Registered study purpose

“This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.” (opens the source at this quote in a new tab)

Primary objective of the Phase 3 program

“The primary objective of the Phase 3 program is to evaluate and compare the safety, IOP-lowering efficacy, and BCDVA efficacy of the BIM-IOL System versus control in participants with OAG or OHT undergoing cataract surgery.” (opens the source at this quote in a new tab)
“Both trials are designed to demonstrate noninferiority of the BIM-IOL System to a standard of care commercial IOL plus twice-daily administration of timolol eye drops.” (opens the source at this quote in a new tab)

Study dates

Milestone	Registry record
Study start (actual)	“2025-10-15”
Primary completion (estimated)	“2029-03-31”
Study completion (estimated)	“2031-03-31”
First posted	“2025-10-20”

Registered recruiting site

Field	Registry record
Facility	“Houston Eye Associates”
City	“Houston”
State	“Texas”
Country	“United States”

Planned countries, sites, and enrollment timeline

“Each trial is expected to enroll approximately 400 patients across 45 clinical sites. The trials are being conducted at sites in the United States, New Zealand and Asia.” (opens the source at this quote in a new tab)
“In July 2025, we initiated two identical, registrational, Phase 3 clinical trials to evaluate the BIM-IOL System with 78 mcg of bimatoprost, which is designed to consistently deliver three years of bimatoprost. In January 2026, we announced the randomization of the first patients in our Phase 3 trials.” (opens the source at this quote in a new tab)
“We plan to complete Phase 3 enrollment by 2027 and report 12 month data in 2028 and 24 month data in 2029.” (opens the source at this quote in a new tab)

First randomization announced January 2026

“SpyGlass Pharma, a late-stage biopharmaceutical company, today announced that the first patients have been randomized in two registrational Phase III clinical trials of its lead product candidate, the Bimatoprost Drug Pad-IOL System (BIM-IOL System), for lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).” (opens the source at this quote in a new tab)

Enrollment status as of August 2026

“Enrollment remains on track in the registrational Phase 3 trials of the Bimatoprost Drug Pad-IOL System (BIM-IOL System), with completion of enrollment expected in 2027.” (opens the source at this quote in a new tab)

Registered design

“A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,” (opens the source at this quote in a new tab)

Design element	Registry record
Study type	“Interventional”
Phase	“Phase 3”
Allocation	“Randomized”
Intervention model	“Parallel Assignment”
Primary purpose	“Treatment”
Masking	“Double”
Masked roles	“Participant”, “Outcomes Assessor”

Two identical trials, 1:1 randomization, noninferiority design

“Enrolled patients will be randomized into two groups at a ratio of 1:1 to receive the BIM-IOL System (78 mcg) or a commercially available monofocal IOL with twice-daily administration of timolol maleate 0.5%, as the control group. Enrolled patients who meet the surgical eligibility criteria will receive cataract surgery in one eye (the study eye) after receiving a baseline washout of all IOP-lowering medications.” (opens the source at this quote in a new tab)
“Participants will be followed through 36 months, allowing us to compare long-term safety, efficacy, and durability.” (opens the source at this quote in a new tab)

Protocol changes from the Phase 1/2 trial

“Informed by our Phase 1/2 data, we have implemented minor protocol modifications to the inclusion and exclusion criteria. Key changes include tightening the baseline IOP range, enrolling patients on up to two IOP-lowering medications, tailoring washout periods based on drug class pharmacokinetics, and standardizing IOP measurement timing. The changes are intended to improve consistency across trial arms.” (opens the source at this quote in a new tab)

Registered inclusion criteria

“Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension” (opens the source at this quote in a new tab)
“Planned removal of cataract” (opens the source at this quote in a new tab)
“Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception” (opens the source at this quote in a new tab)

Field	Registry record
Minimum age	“22 Years”
Sex	“All”

Registered exclusion criteria

“Uncontrolled systemic disease” (opens the source at this quote in a new tab)
“History of incisional/refractive corneal surgery” (opens the source at this quote in a new tab)
“Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma” (opens the source at this quote in a new tab)
“History of incisional glaucoma surgery or intraocular injections” (opens the source at this quote in a new tab)
“Other ocular diseases, pathology, or conditions” (opens the source at this quote in a new tab)

Baseline medication burden permitted

“Each prospective, multicenter, randomized, masked, controlled Phase 3 clinical trial evaluates the safety and efficacy of the BIM-IOL System (78 mcg) in patients with OAG or OHT and a concomitant cataract, who are taking up to two IOP-lowering medications.” (opens the source at this quote in a new tab)

Registered arms and interventions

Arm	Arm type	Quoted intervention description
“Bimatoprost Implant System / IOL Combination”	“Experimental”	“Bimatoprost Implant System used in combination with the SpyGlass IOL”; “SpyGlass Intraocular Lens”
“Timolol Maleate Ophthalmic Solution 0.5%”	“Active Comparator”	“Timolol Maleate Ophthalmic Solution, 0.5% BID”; “Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens”

Dose and intended duration of drug delivery

“In July 2025, we initiated two identical, registrational, Phase 3 clinical trials to evaluate the BIM-IOL System with 78 mcg of bimatoprost, which is designed to consistently deliver three years of bimatoprost.” (opens the source at this quote in a new tab)

Registered primary and secondary outcomes

Outcome type	Measure	Description	Time frame
Primary	“Mean IOP Reduction from Baseline (mmHg)”	“Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints”	“Weeks 2 and 6, and Month 3”
Primary	“BCDVA 20/40 or better”	“Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better”	“Month 6”
Secondary	“Mean IOP Reduction from Baseline (mmHg)”	“Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints”	“Month 6, 9 and 12”

Co-primary and secondary endpoints as described by the sponsor

“The co-primary endpoints are (1) the time-matched mean IOP change from baseline at 8 and 10 a.m. at two and six weeks and three months and (2) BCDVA of 20/40 or better at 12 months. Secondary outcome measures will also be evaluated, including mean IOP, time to postoperative introduction of IOP-lowering medications, and number of IOP-lowering medications introduced postoperatively.” (opens the source at this quote in a new tab)

Rationale for IOP as the efficacy endpoint

“The reduction of IOP is currently the only known modifiable risk factor that has been borne out by large randomized controlled clinical trials to reduce both the risk of developing glaucoma and the progression of existing disease” (opens the source at this quote in a new tab)

Rationale for the BCDVA co-primary endpoint and the noninferiority margin

No evidence found.

Planned enrollment

Enrollment type	Participants
Estimated	“400”

Analyzed population

No evidence found.

Summary

SGP-005 was recruiting at the time of the most recent sponsor update (August 2026), with enrollment completion expected in 2027, 12-month data in 2028, and 24-month data in 2029; no results are available. The comparator is a commercial monofocal IOL plus twice-daily timolol 0.5%, not a prostaglandin analog, sustained-release implant, or MIGS procedure. The registry record lists the BCDVA co-primary endpoint at Month 6, whereas the sponsor's Form 10-K describes it at 12 months. The registry record lists one U.S. site, whereas the sponsor describes approximately 45 sites per trial in the United States, New Zealand, and Asia. The registry record states the study start as October 15, 2025, whereas the Form 10-K states that the Phase 3 trials were initiated in July 2025. No noninferiority margin or statistical analysis plan has been published.

Registered study purpose

“This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.” (opens the source at this quote in a new tab)

Primary objective of the Phase 3 program

“The primary objective of the Phase 3 program is to evaluate and compare the safety, IOP-lowering efficacy, and BCDVA efficacy of the BIM-IOL System versus control in participants with OAG or OHT undergoing cataract surgery.” (opens the source at this quote in a new tab)

Study dates

Milestone	Registry record
Study start (estimated)	“2025-10-28”
Primary completion (estimated)	“2029-05-31”
Study completion (estimated)	“2031-05-31”
First posted	“2025-10-20”

Registered recruiting site

Field	Registry record
Facility	“R and R Eye Research, LLC”
City	“San Antonio”
State	“Texas”
Country	“United States”

Planned countries, sites, and enrollment timeline

“Each trial is expected to enroll approximately 400 patients across 45 clinical sites. The trials are being conducted at sites in the United States, New Zealand and Asia.” (opens the source at this quote in a new tab)
“We plan to complete Phase 3 enrollment by 2027 and report 12 month data in 2028 and 24 month data in 2029.” (opens the source at this quote in a new tab)

First randomization and enrollment status

“The two registrational Phase 3 trials, SGP-005 and SGP-006, are designed to demonstrate non-inferiority of the BIM-IOL System to a state-of-the-art commercial IOL with twice-daily topical timolol. SpyGlass Pharma continues to expect that both trials will complete enrollment in 2027.” (opens the source at this quote in a new tab)

Registered design

“A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,” (opens the source at this quote in a new tab)

Design element	Registry record
Study type	“Interventional”
Phase	“Phase 3”
Allocation	“Randomized”
Intervention model	“Parallel Assignment”
Primary purpose	“Treatment”
Masking	“Double”
Masked roles	“Participant”, “Outcomes Assessor”

Phase III program design as announced

“The Phase III clinical trial program consists of two prospective, multicenter, randomized, masked, controlled clinical trials, SGP-005 and SGP-006, evaluating the efficacy and safety of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery. Each trial is expected to enroll approximately 400 participants and is designed to demonstrate non-inferiority of the BIM-IOL System to a standard of care commercial intraocular lens (IOL) with twice-daily administration of timolol eye drops.” (opens the source at this quote in a new tab)
“Participants will be monitored for up to 36 months to evaluate long-term safety, efficacy, and durability.” (opens the source at this quote in a new tab)

Protocol changes from the Phase 1/2 trial

“Key changes include tightening the baseline IOP range, enrolling patients on up to two IOP-lowering medications, tailoring washout periods based on drug class pharmacokinetics, and standardizing IOP measurement timing.” (opens the source at this quote in a new tab)

Registered inclusion criteria

“Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension” (opens the source at this quote in a new tab)
“Planned removal of cataract” (opens the source at this quote in a new tab)
“Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception” (opens the source at this quote in a new tab)

Field	Registry record
Minimum age	“22 Years”
Sex	“All”

Registered exclusion criteria

“Uncontrolled systemic disease” (opens the source at this quote in a new tab)
“History of incisional/refractive corneal surgery” (opens the source at this quote in a new tab)
“Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma” (opens the source at this quote in a new tab)
“History of incisional glaucoma surgery or intraocular injections” (opens the source at this quote in a new tab)
“Other ocular diseases, pathology, or conditions” (opens the source at this quote in a new tab)

Baseline medication burden permitted

“Each prospective, multicenter, randomized, masked, controlled Phase 3 clinical trial evaluates the safety and efficacy of the BIM-IOL System (78 mcg) in patients with OAG or OHT and a concomitant cataract, who are taking up to two IOP-lowering medications.” (opens the source at this quote in a new tab)

Registered arms and interventions

Arm	Arm type	Quoted intervention description
“Bimatoprost Implant System / IOL Combination”	“Experimental”	“Bimatoprost Implant System used in combination with the SpyGlass IOL”; “SpyGlass Intraocular Lens”
“Timolol Maleate Ophthalmic Solution 0.5%”	“Active Comparator”	“Timolol Maleate Ophthalmic Solution, 0.5% BID”; “Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens”

Randomization ratio and washout

“Enrolled patients will be randomized into two groups at a ratio of 1:1 to receive the BIM-IOL System (78 mcg) or a commercially available monofocal IOL with twice-daily administration of timolol maleate 0.5%, as the control group. Enrolled patients who meet the surgical eligibility criteria will receive cataract surgery in one eye (the study eye) after receiving a baseline washout of all IOP-lowering medications.” (opens the source at this quote in a new tab)

Registered primary and secondary outcomes

Outcome type	Measure	Description	Time frame
Primary	“Mean IOP Reduction from Baseline (mmHg)”	“Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints”	“Weeks 2 and 6, and Month 3”
Primary	“BCDVA 20/40 or better”	“Study eyes achieving best corrected distance visual acuity (BCDVA) of 20/40 or better”	“Month 6”
Secondary	“Mean IOP Reduction from Baseline (mmHg)”	“Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints”	“Month 6, 9 and 12”

Co-primary and secondary endpoints as announced

“The co-primary endpoints are the time-matched change in mean IOP from baseline, as well as the proportion of patients achieving best corrected distance visual acuity (BCDVA) of 20/40 or better. The studies will also measure change in mean IOP, time to postoperative introduction of IOP-lowering medications, and number of IOP-lowering medications introduced postoperatively.” (opens the source at this quote in a new tab)

Co-primary endpoint timing described in the Form 10-K

“The co-primary endpoints are (1) the time-matched mean IOP change from baseline at 8 and 10 a.m. at two and six weeks and three months and (2) BCDVA of 20/40 or better at 12 months.” (opens the source at this quote in a new tab)

Rationale for IOP as the efficacy endpoint

“The reduction of IOP is currently the only known modifiable risk factor that has been borne out by large randomized controlled clinical trials to reduce both the risk of developing glaucoma and the progression of existing disease” (opens the source at this quote in a new tab)

Rationale for the BCDVA co-primary endpoint and the noninferiority margin

No evidence found.

Planned enrollment

Enrollment type	Participants
Estimated	“400”

Analyzed population

No evidence found.

Summary

SGP-006 has the same registered design, eligibility criteria, arms, and outcomes as SGP-005 and was recruiting at the most recent sponsor update, with enrollment completion expected in 2027; no results are available. The registry start date (October 28, 2025) is recorded as estimated, and the record lists one U.S. site. As for SGP-005, the registry lists the BCDVA co-primary endpoint at Month 6 while the sponsor's Form 10-K states 12 months, the active comparator is twice-daily timolol 0.5% with a commercial monofocal IOL, and no noninferiority margin or statistical analysis plan has been published.

Registered study purpose

“This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.” (opens the source at this quote in a new tab)

Dose selection objective

“Based on the results of our FIH trial, we designed a Phase 1/2 trial to evaluate the safety and efficacy of the BIM-IOL System with 39 mcg and 78 mcg of bimatoprost, which are designed to have similar daily release profiles to the 75 and 150 mcg doses in our FIH trial, respectively.” (opens the source at this quote in a new tab)

Study dates

Milestone	Registry record
Study start (actual)	“2023-10-13”
Primary completion (actual)	“2025-01-31”
Study completion (estimated)	“2027-11”
Overall status	“Active, not recruiting”

Countries and enrollment completion

“The trial is being conducted at sites in the United States, New Zealand and Asia.” (opens the source at this quote in a new tab)
“Our investigational new drug application (IND) for the Phase 1/2 trial of the BIM-IOL System in patients with OAG or OHT undergoing cataract surgery was cleared by the FDA, and we completed enrollment in November 2024.” (opens the source at this quote in a new tab)

Registered site

Field	Registry record
Facility	“Arizona Advanced Eye Research Institute”
City	“Glendale”
State	“Arizona”
Country	“United States”

Enrollment completion reported in trade press

“SpyGlass Pharma has completed enrollment in its phase 1/2 clinical trial evaluating a long-term drug delivery platform of bimatoprost for glaucoma and ocular hypertension, according to a press release.” (opens the source at this quote in a new tab)

Registered design

“A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%” (opens the source at this quote in a new tab)

Design element	Registry record
Phase	“Phase 1”, “Phase 2”
Allocation	“Randomized”
Intervention model	“Parallel Assignment”
Masking	“Quadruple”
Masked roles	“Participant”, “Care Provider”, “Investigator”, “Outcomes Assessor”

Randomization, washout, and IOP measurement schedule

“Our prospective, multicenter, randomized, double-masked, controlled Phase 1/2 clinical trial evaluates the safety and efficacy of the BIM-IOL System in patients previously diagnosed with OAG or OHT and a concomitant cataract, who are taking up to three IOP-lowering medications.” (opens the source at this quote in a new tab)
“The 104 enrolled patients who met the surgical eligibility criteria received cataract surgery in one eye (the study eye) after receiving a baseline washout of all IOP-lowering medications. Patients are examined at two time points (8 and 10 a.m.) for each follow-up visit at two weeks, six weeks and three months, and will continue to be followed through at least 36 months.” (opens the source at this quote in a new tab)

Registered inclusion criteria

“Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension” (opens the source at this quote in a new tab)
“Planned removal of cataract” (opens the source at this quote in a new tab)
“Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception” (opens the source at this quote in a new tab)

Field	Registry record
Minimum age	“22 Years”
Sex	“All”

Registered exclusion criteria

“Uncontrolled systemic disease” (opens the source at this quote in a new tab)
“History of incisional/refractive corneal surgery” (opens the source at this quote in a new tab)
“Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma” (opens the source at this quote in a new tab)
“History of incisional glaucoma surgery or intraocular injections” (opens the source at this quote in a new tab)
“Other ocular diseases, pathology, or conditions” (opens the source at this quote in a new tab)

Registered arms and interventions

Arm	Arm type	Quoted intervention description
“Bimatoprost Implant System (High Dose) / IOL Combination”	“Experimental”	“Bimatoprost Implant System (High Dose) used in combination with the SpyGlass IOL”
“Bimatoprost Implant System (Low Dose) / IOL Combination”	“Experimental”	“Bimatoprost Implant System (Low Dose) used in combination with the SpyGlass IOL”
“Timolol Maleate Ophthalmic Solution 0.5%”	“Active Comparator”	“Timolol Maleate Ophthalmic Solution 0.5% BID”; “Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens”

Doses, allocation ratio, and concomitant eye drops

“A total of 104 patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) and 39 mcg BIM-IOL System (N=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL from Alcon, Bausch + Lomb or Johnson & Johnson with twice-daily administration of timolol eye drops as the control group (N=30).” (opens the source at this quote in a new tab)

Intended delivery duration

“The BIM-IOL System in the Phase 1/2 trial is designed to deliver bimatoprost over three years.” (opens the source at this quote in a new tab)

Registered primary, secondary, and other outcomes

Outcome type	Measure	Time frame
Primary	“Mean IOP Reduction from Baseline (mmHg)”	“Weeks 2 and 6, and Month 3”
Secondary	“Mean IOP”	“Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36”
Secondary	“Mean IOP Change from Baseline”	“Months 6, 12, 18, 24, 27, 30, 33, and 36”
Secondary	“Time to postoperative introduction of IOP-lowering medications”	“Total Study Period of 36 Months”
Secondary	“Number of IOP-lowering medications introduced postoperatively”	“Total Study Period of 36 Months”
Secondary	“Proportion of eyes achieving BCDVA 20/40 or better”	“Months 3, 6, and 12”
Secondary	“Manifest refraction spherical equivalent”	“Month 3”
Other	“Number and Rates of Adverse Events”	“Total Study Period of 36 Months”

Endpoints as described by the sponsor

“The primary endpoint of the Phase 1/2 trial is the mean IOP reduction from baseline at multiple time points of follow-up. Secondary endpoints include mean IOP reduction from baseline, mean IOP, time to reintroduction and number of IOP-lowering medications, and proportion of eyes achieving BCDVA 20/40 or better. Safety endpoints include assessment of AEs, endothelial cell density, slit lamp examination, and patient-reported quality of vision, each at multiple time points of follow-up.” (opens the source at this quote in a new tab)

Rationale for IOP as the efficacy endpoint

“The reduction of IOP is currently the only known modifiable risk factor that has been borne out by large randomized controlled clinical trials to reduce both the risk of developing glaucoma and the progression of existing disease” (opens the source at this quote in a new tab)

Registered enrollment

Enrollment type	Participants
Actual	“201”

Randomized and treated participants

“The 104 enrolled patients who met the surgical eligibility criteria received cataract surgery in one eye (the study eye) after receiving a baseline washout of all IOP-lowering medications.” (opens the source at this quote in a new tab)

Evaluable participants at 12 months

“Evaluable patients in the 78-mcg (N=47) and 39-mcg (N=21) dose groups achieved a 34% and 42% reduction in mean IOP from baseline, respectively, compared to a 35% reduction in the control (N=29) group at 8 a.m.” (opens the source at this quote in a new tab)
“98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications.” (opens the source at this quote in a new tab)

Statistical methods and analysis sets

No evidence found.

Summary

The registry record lists an actual enrollment of 201 participants, while all company disclosures report 104 randomized participants (78 mcg, n=51; 39 mcg, n=23; timolol control, n=30). The difference may reflect consented participants who did not meet surgical eligibility criteria, but no source reconciles the two counts. At 3 months, medication-free status was reported for 50 evaluable participants in the 78-mcg group. At 12 months, 49 (78 mcg) and 23 (39 mcg) participants were evaluable for medication-free status, and 47 (78 mcg), 21 (39 mcg), and 29 (control) participants were evaluable for IOP at 8 a.m. Reasons for non-evaluability were not reported.

Randomized population

“A total of 104 eligible patients were randomized 2:1:1 to receive the 78 mcg BIM-IOL System (N=51) with daily administration of artificial tear drops, 39 mcg BIM-IOL System (N=23) with daily administration of artificial tear drops, or a commercially available monofocal IOL with twice-daily administration of timolol eye drops as the control group (N=30).” (opens the source at this quote in a new tab)

Baseline topical medication use and visual acuity

“At baseline, 30% to 37% of patients were not taking topical IOP-lowering medications, but would benefit from pressure reduction.” (opens the source at this quote in a new tab)
“As shown in the figure below, the 78 mcg, 39 mcg, and control groups all demonstrated similar improvement, with measures ranging from 76 to 78 letters (approximately equivalent to 20/30 vision) at baseline and improving to 85 to 86 letters (approximately equivalent to 20/20 vision) at three months.” (opens the source at this quote in a new tab)

Baseline demographics and baseline IOP by group

No evidence found.

Summary: 3-month and 12-month topline results

At 3 months (primary endpoint period), mean IOP reductions from baseline at 8 a.m. were 37% (78 mcg), 36% (39 mcg), and 37% (timolol control); absolute reductions were -9.29 mmHg (8 a.m.) and -9.19 mmHg (10 a.m.) for 78 mcg, -9.64 and -8.70 mmHg for 39 mcg, and -9.63 and -10.24 mmHg for control. No between-group statistical comparison or noninferiority analysis was reported. At 3 months, 49 of 50 (98%) participants in the 78-mcg group and 22 of 23 (96%) in the 39-mcg group were free of topical IOP-lowering medications, and all participants had BCDVA of 20/40 or better.

At 12 months, evaluable participants had mean IOP reductions of 34% (78 mcg, n=47), 42% (39 mcg, n=21), and 35% (control, n=29) at 8 a.m.; 48 of 49 (98%) in the 78-mcg group and 22 of 23 (96%) in the 39-mcg group were free of topical IOP-lowering medications; and 72 of 72 (100%) evaluable BIM-IOL participants had BCDVA of 20/32 or better, with mean BCDVA of 86 letters. Company summaries also describe 97% of treated participants as drop-free at 3 and 12 months. Absolute 12-month IOP values, 10 a.m. percentages, variance estimates, and p values were not published. No peer-reviewed publication or congress abstract with full Phase 1/2 data was identified; the company stated that additional results would be presented at a future medical meeting.

IOP reduction at 3 months: percentage and absolute change

“At three months, the BIM-IOL System demonstrated a mean IOP reduction of 37% and 36% in the 78 mcg and 39 mcg dose groups, respectively. IOP reductions were comparable to the control group at three months in both dose groups, as expected.” (opens the source at this quote in a new tab)
“At three months, we observed mean IOP reductions of -9.29 mmHg (8 a.m.) and -9.19 mmHg (10 a.m.) for the 78 mcg dose group, -9.64 mmHg (8 a.m.) and -8.70 mmHg (10 a.m.) for the 39 mcg dose group, and -9.63 mmHg (8 a.m.) and -10.24 mmHg (10 a.m.) for the control group.” (opens the source at this quote in a new tab)

IOP reduction, medication-free status, and visual acuity at 3 months as presented at IGC 2025

“Patients achieved a 37% and 36% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 37% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint (Figure 1).” (opens the source at this quote in a new tab)
“98% of patients (49 of 50) in the 78-mcg dose group and 96% of patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications.” (opens the source at this quote in a new tab)
“Patients demonstrated vision improvement, reaching 20/40 or better BCDVA and mean BCDVA of 85 to 86 letters (~20/20 vision).” (opens the source at this quote in a new tab)

IOP reduction, medication-free status, and visual acuity at 12 months

“Evaluable patients achieved a 34% and 42% reduction in mean IOP from baseline in the 78-mcg and 39-mcg dose groups, respectively, compared to a 35% reduction in the control group at 8 a.m. Results were similar at the 10 a.m. timepoint.” (opens the source at this quote in a new tab)
“98% of evaluable patients (48 of 49) in the 78-mcg dose group and 96% of evaluable patients (22 of 23) in the 39-mcg dose group were free from all topical IOP-lowering medications.” (opens the source at this quote in a new tab)
“Evaluable patients (N=72) demonstrated vision improvement, 100% reaching 20/32 or better best corrected distance visual acuity (BCDVA) and mean BCDVA of 86 letters (equivalent to 20/20 vision).” (opens the source at this quote in a new tab)

Pooled medication-free rate reported in company summaries

“In our Phase 1/2 multicenter, randomized, controlled trial, which is evaluating the safety and efficacy of the BIM-IOL System, patients who received the BIM-IOL System in the 78 mcg and 39 mcg dose groups achieved mean IOP reductions of 37% and 36%, respectively, at three months and sustained similar rates of mean IOP reduction at twelve months. 97% of treated patients were off topical IOP-lowering drops at three and twelve months, and the BIM-IOL System was observed to be well tolerated at both three and twelve months.” (opens the source at this quote in a new tab)

Independent trade-journal summary of Phase 1/2 results

“The latest available phase 1/2 data showed that, at 12 months, patients achieved a mean IOP reduction of 34% and 42% in the 78-µg and 39-µg dose groups, respectively, compared to a 35% reduction in the control group. In addition, 97% of patients who received the BIM-IOL had discontinued all topical IOP-lowering therapy, 100% achieved a distance BCVA of 20/32 or better, and the mean distance BCVA was equivalent to 20/20 vision.” (opens the source at this quote in a new tab)

Peer-reviewed publication or congress abstract of Phase 1/2 results

No evidence found.

Planned patient-reported quality of vision assessment

“Safety endpoints include assessment of AEs, endothelial cell density, slit lamp examination, and patient-reported quality of vision, each at multiple time points of follow-up.” (opens the source at this quote in a new tab)

Patient-reported outcome results

No evidence found.

Adverse event rates and serious events at 3 and 12 months

“In the Phase 1/2 trial, the overall safety results of the BIM-IOL System at three months were comparable to the control group. Only one patient receiving the BIM-IOL System reported allergic conjunctivitis (1/50, 2.0%) and there were no other reports of conjunctival hyperemia. Similar AE rates were observed in the 78 mcg (35.3%), 39 mcg (39.1%) and the control (33.3%) groups.” (opens the source at this quote in a new tab)
“AE rates were similar across the 78-mcg (41.2%), 39-mcg (43.5%), and control (36.7%) groups. No serious ocular AEs were observed.” (opens the source at this quote in a new tab)

Most common study-eye adverse events through 3 months (3% or greater in any group)

Adverse event	78 mcg, n = 51, n (%)	39 mcg, n = 23, n (%)	Control, n = 30, n (%)
Eye disorders	“17 (33.3)”	“8 (34.8)”	“9 (30.0)”
Iritis	“4 (7.8)”	“1 (4.3)”	“1 (3.3)”
Corneal edema	“3 (5.9)”	“2 (8.7)”	“1 (3.3)”
Keratitis	“1 (2.0)”	“0”	“1 (3.3)”
Eye pruritus	“0”	“0”	“1 (3.3)”
Eye inflammation	“3 (5.9)”	“0”	“0”
Visual impairment (i.e., halos)	“2 (3.9)”	“0”	“0”
Dry eye	“0”	“4 (17.4)”	“1 (3.3)”
Visual acuity reduced (BCDVA loss ≥ 10 letters)	“2 (3.9)”	“2 (8.7)”	“2 (6.7)”
Corneal defect	“0”	“1 (4.3)”	“0”
Meibomian gland dysfunction	“4 (7.8)”	“0”	“2 (6.7)”
Anterior capsule contraction	“0”	“1 (4.3)”	“0”
Vitreous detachment	“1 (2.0)”	“0”	“1 (3.3)”
Pterygium	“0”	“0”	“1 (3.3)”
Swelling of eyelid	“0”	“0”	“1 (3.3)”
General disorders and conditions	“0”	“0”	“1 (3.3)”
Impaired Healing	“0”	“0”	“1 (3.3)”
Infections (i.e., conjunctivitis, periorbital cellulitis, hordeolum)	“2 (3.9)”	“1 (4.3)”	“0”

Severity of cumulative ocular adverse events at 3 months

Severity	78 mcg, N = 51, n (%)	39 mcg, N = 23, n (%)	Control, N = 30, n (%)
Cumulative	“18 (35.3)”	“9 (39.1)”	“10 (33.3)”
Mild	“15 (29.4)”	“8 (34.8)”	“8 (26.7)”
Severe	“0”	“1 ( 4.3)”	“0”

Severe adverse event and corneal endothelial cell density

“There was one instance of dry eye reported in the 39 mcg dose group that was rated as severe and determined to be unrelated to the investigational product.” (opens the source at this quote in a new tab)
“Endothelial cell density loss was within the expected range for post-cataract surgery glaucoma patients, with patients receiving the BIM-IOL System demonstrating an average loss of 14.9% compared to 12.1% in the control group. Importantly, endothelial cell density levels remained stable between three and six months.” (opens the source at this quote in a new tab)

Adverse events by type at 12 months

No evidence found.

Summary

All Phase 1/2 results available as of September 2026 are sponsor-reported topline data from press releases and SEC filings; no peer-reviewed publication, congress abstract, or registry results posting was identified. The trial was not described as powered for noninferiority, and no confidence intervals, p values, or between-group tests were published. Registered enrollment (201) differs from the randomized population (104), and 12-month IOP analyses used evaluable subsets (47 of 51, 21 of 23, and 29 of 30). The 12-month IOP reduction for the 78-mcg dose (34%) was lower than at 3 months (37%) and numerically lower than the 39-mcg dose (42%), while the Form 10-K describes the reduction as sustained at similar rates. The active control was timolol 0.5% twice daily rather than a prostaglandin analog. The drug pads are non-bioerodible and designed for 3 years of delivery; efficacy after drug depletion and retreatment options have not been reported. The sponsor also reported that 30% to 37% of participants were not taking topical IOP-lowering medications at baseline.

Registered study purpose

“The goal of this clinical trial is to further observe and learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also further observe and learn about the safety of the Bimatoprost Implant System / IOL Combination.” (opens the source at this quote in a new tab)

Rationale for extended follow-up

“At that time, findings were reviewed, and the decision was made to extend study monitoring through 7 years. This was done to better guide future study design and to provide surgeons with further information on a device that had already generated anecdotal interest.” (opens the source at this quote in a new tab)

Study dates and site

Field	Registry record
Study start (actual)	“2023-03-16”
Primary completion (estimated)	“2031-04-14”
Study completion (estimated)	“2031-04-14”
First submitted	“2025-08-22”
Facility	“Centro Oftalmológico Robles”
City	“Santa Rosa de Copán”
Country	“Honduras”

Retrospective registration

“Trial registration was performed retrospectively, on September 3, 2025, to enable publication of the findings for interested ophthalmologists to critique.” (opens the source at this quote in a new tab)

Registered observational design

Design element	Registry record
Study type	“Observational”
Observational model	“Cohort”
Time perspective	“Prospective”
Sampling method	“Non-Probability Sample”

“Observational Study to Evaluate Long-term Follow-up of Subjects Implanted With Sustained-release Bimatoprost With the SpyGlass IOL in Subjects With Ocular Hypertension or Mild-to-moderate Open-angle Glaucoma” (opens the source at this quote in a new tab)
“This is an observational extension to a proof of concept trial (first in human).” (opens the source at this quote in a new tab)

Protocol amendment, visit schedule, and IOP measurement

“The protocol was amended to include future follow-up visits and the corresponding assessments. Eligible enrollees were reconsented accordingly.” (opens the source at this quote in a new tab)
“For this interim report, postoperative follow-up visits occurred at day 1, week 1, and months 1, 3, 6, 9, 12, 18, 24, 30, and 36.” (opens the source at this quote in a new tab)
“All scheduled IOP measurements were performed at approximately 8 AM. To minimize bias, IOP was assessed by two observers” (opens the source at this quote in a new tab)

Registered eligibility criteria and study population

“Be able to understand a written informed consent and be willing to participate by evidence of signing an informed consent form” (opens the source at this quote in a new tab)
“Met all inclusion criteria, participated in and completed the SGP-SPEC-001 study” (opens the source at this quote in a new tab)
“Planned participation in another clinical trial within 30 days of the initial study visit that, in the investigator's opinion, could confound the study results” (opens the source at this quote in a new tab)
“Ocular hypertension or open-angle glaucoma participants in Honduras who completed the SpyGlass Pharma Inc. SGP-SPEC-001 study.” (opens the source at this quote in a new tab)

Exclusion of the participant with preexisting diabetic retinopathy

“Data was collected for this patient with diabetic retinopathy up to and including month 6, the end of the initial pilot, but they did not partake in extended study follow-up.” (opens the source at this quote in a new tab)

Dose cohorts followed (no new intervention)

Cohort	Registry arm label
Low dose	“Bimatoprost Implant System / IOL Combination Low Dose”
Medium dose	“Bimatoprost Implant System / IOL Combination Medium Dose”
High dose	“Bimatoprost Implant System / IOL Combination High Dose”

Bimatoprost content by cohort

“One eye of each subject was sequentially assigned to one of three arms (75 μg, 150 μg, or 300 μg of bimatoprost pads).” (opens the source at this quote in a new tab)

Registered primary and other outcomes

Outcome type	Measure	Time frame
Primary	“Unmedicated eyes with an IOP Reduction from SGP-SPEC-001 Baseline”	“From Month 9 post-operative through the end of post-operative follow-up at Month 84”
Other	“Mean change in unmedicated IOP from SGP-SPEC-001 baseline visit for each follow-up time up to the month 84 exam.”	“From Month 9 post-operative through the end of post-operative follow-up at Month 84”
Other	“Assessment of Postoperative Adverse Events”	“From Month 9 post-operative through the end of post-operative follow-up at Month 84”
Other	“Supplementary Safety Parameter - Specular Microscopy”	“Month 12 post-operative”

Primary outcome definition

“The proportion of eyes that remain unmedicated and with an IOP reduction ≥ 20% from the SGP-SPEC-001 baseline visit for each follow-up time through the month 84 exam.” (opens the source at this quote in a new tab)

Rationale for the 20% IOP reduction threshold

No evidence found.

Registered enrollment

Enrollment type	Participants
Actual	“23”

Participants analyzed at 36 months

“Twenty-one of 24 enrollees (87.5%) were retained through 36 months.” (opens the source at this quote in a new tab)

Per-protocol and intention-to-treat analyses, statistical tests, and handling of rescue medication

“To focus on the effect of the technology on a consistent cohort inclusive of the other 23 enrollees who completed subsequent visits, we primarily implemented a per-protocol approach. An intention-to-treat analysis, including the subject with preexisting diabetic retinopathy, is included in the Supplementary Material.” (opens the source at this quote in a new tab)
“Paired IOP outcomes were analyzed using the Wilcoxon signed-rank test. Comparisons between mean IOPs across the three treatment arms were conducted via the Kruskal–Wallis test and with mixed model repeated measure analysis. If an ocular antihypertensive medication was reintroduced in a subject during follow-up, the IOP values used for analyses at subsequent visits were carried forward from the last unmedicated IOP.” (opens the source at this quote in a new tab)

Retention through 36 months

“All 23 subjects were retained through the month 30 follow-up visit. Between months 30 and 36, two subjects in the high-dose cohort withdrew. The first subject moved to another country, and the second exited to undergo palliative care in the setting of newly diagnosed pancreatic cancer.” (opens the source at this quote in a new tab)

Baseline characteristics of the extension cohort

Characteristic	Data (n = 23)
Age, mean years ± SD	“70.5 ± 9.6”
Female, n (%)	“12 (52.2%)”
Hispanic or Latino, n (%)	“23 (100%)”
Primary open-angle glaucoma, n (%)	“23 (100%)”
Ocular hypertension, n (%)	“0 (0%)”
Pre-washout screening IOP, mean mmHg ± SD	“16.5 ± 3.5”
Post-washout baseline IOP, mean mmHg ± SD	“25.1 ± 2.5”
One ocular hypotensive medication, n (%)	“20 (87.0%)”
Two ocular hypotensive medications, n (%)	“1 (4.3%)”
Three ocular hypotensive medications, n (%)	“2 (8.7%)”
Endothelial cell density, mean cells/mm2 ± SD	“2308 ± 223”

Summary: IOP and medication outcomes from month 9 through month 36

In the per-protocol cohort, mean IOP decreased from 25.1 ± 2.5 mmHg at post-washout baseline to 13.8 ± 2.4 mmHg at month 9, 13.9 ± 2.3 mmHg at month 12, 14.5 ± 3.0 mmHg at month 24, and 15.9 ± 2.8 mmHg at month 36 (n=21), corresponding to mean reductions of 44.6%, 44.0%, 41.9%, and 36.7% (p < 0.0001 at each visit). All 21 eyes followed to month 36 maintained an IOP reduction greater than 20%, and 19 of 21 (90.5%) had IOP below 18 mmHg. All 16 participants in the 75 μg and 150 μg cohorts remained drop-free through month 36; one participant in the 300 μg cohort restarted topical medication at month 30, giving 20 of 21 (95.2%) drop-free at 36 months. Month-36 IOP did not differ significantly among dose cohorts (p = 0.50), and the 300 μg cohort (n=5) did not reach statistical significance for IOP reduction from baseline (p = 0.06). The sponsor reported that 4-year follow-up data are expected in the fourth quarter of 2026.

IOP over time, overall per-protocol sample

Measure	Month 9	Month 12	Month 18	Month 24	Month 30	Month 36
Study eyes, n	“23”	“23”	“23”	“23”	“23”	“21”
IOP, mean mmHg ± SD	“13.8 ± 2.4”	“13.9 ± 2.3”	“13.9 ± 2.2”	“14.5 ± 3.0”	“15.2 ± 3.2”	“15.9 ± 2.8”
% IOP reduction from baseline	“44.6 ± 8.9”	“44.0 ± 11.1”	“44.4 ± 8.8”	“41.9 ± 11.5”	“39.3 ± 12.0”	“36.7 ± 9.4”
% eyes with ≥ 20% reduction (95% exact CI)	“100% (85%, 100%)”	“100% (85%, 100%)”	“100% (85%, 100%)”	“100% (85%, 100%)”	“91.3% (72%, 99%)”	“100% (84%, 100%)”
p value (CFB among Tx)	“1.00”	“0.84”	“0.42”	“0.99”	“0.28”	“0.50”

IOP at month 36 by dose cohort

Measure	75 μg	150 μg	300 μg
Study eyes, n	“8”	“8”	“5”
IOP, mean mmHg ± SD	“14.9 ± 2.0”	“17.2 ± 2.5”	“15.3 ± 3.8”
% IOP reduction from baseline	“39.5 ± 6.3”	“32.3 ± 9.4”	“39.3 ± 12.4”
p value (CFB = 0)	“0.0078”	“0.0078”	“0.06”

Medication-free status and IOP targets through month 36

“Through month 24, all study eyes continued to maintain an IOP reduction > 20%, and all but one study eye measured at an IOP of 18 mmHg or less. All 16 subjects in the 75 μg and 150 μg cohorts remained off glaucoma drops through month 36. A single subject in the 300 μg arm required reintroduction of a topical IOP-lowering medication at month 30. Thus, at last follow-up, 95.2% of study eyes (n = 20) remained topical medication-free. All month 36 subjects maintained an IOP reduction > 20% and all but two subjects (90.5%, n = 19) achieved an IOP < 18 mmHg.” (opens the source at this quote in a new tab)
“For the aggregate sample, mean percentage IOP reduction from baseline was 36.7 ± 9.4% (p < 0.0001) by month 36.” (opens the source at this quote in a new tab)
“This model resulted in a two-sided p value of 0.36 for the time in months by treatment interaction, showing no overall difference between groups in IOP change over time.” (opens the source at this quote in a new tab)

36-month results as reported by the sponsor

“At 36 months, 95% of evaluable patients (n=21) were off all topical IOP-lowering drops. In addition, we observed a statistically significant reduction in mean IOP from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.8 mmHg at 36 months (p<0.0001), with a mean IOP reduction of 37% across all doses compared to baseline.” (opens the source at this quote in a new tab)

Visual acuity at 36 months

“From month 18 through month 36, 100% of study eyes maintained a BCDVA of 20/30 or better.” (opens the source at this quote in a new tab)

BCDVA	Screening	36 Months
n	“23”	“21”
20/20 or better	“0%”	“62%”
20/30 or better	“35%”	“100%”
20/40 or better	“48%”	“100%”

36-month results as presented at the Interventional Glaucoma Consortium 2025

“37% reduction in mean IOP in evaluable patients across all dose groups from 25.1 ± 2.5 mmHg at baseline post-washout to 15.9 ± 2.7 mmHg.” (opens the source at this quote in a new tab)
“95% of evaluable patients were off all topical IOP-lowering medications.” (opens the source at this quote in a new tab)
“100% of evaluable patients achieved 20/30 or better BCDVA.” (opens the source at this quote in a new tab)
“No product-related AEs were reported.” (opens the source at this quote in a new tab)

Earlier data cut: 18 months presented at ASCRS 2025

“To start, patients’ baseline post-washout IOP was 25.1 ± 2.5 mmHg.” (opens the source at this quote in a new tab)
“By 18-months postop, IOP was reduced to 14.1 ± 2.6 mmHg (p < 0.0001).” (opens the source at this quote in a new tab)
“By the 18-month follow-up visit, investigators reported that all 23 patients remained off IOP-lowering topical medications” (opens the source at this quote in a new tab)

Earlier data cut: 18 months presented at Glaucoma 360 2025

“After 18 months, mean IOP reduction was 43.7%, with 96% of patients maintaining pressure at or below 18 mm Hg.” (opens the source at this quote in a new tab)

Earlier data cut: 24 months

“At 24 months, 100% of patients had discontinued topical IOP-lowering therapy, a 42% mean reduction in IOP was achieved across all three bimatoprost doses, and 100% of patients had a distance BCVA of 20/30 or better.” (opens the source at this quote in a new tab)

Four-year follow-up

“BIM-IOL System: Four-year efficacy and safety follow-up expected in fourth quarter of 2026.” (opens the source at this quote in a new tab)

Effect of the two withdrawals in the 300 microgram cohort on the month 36 analysis

“Regarding the two 300 μg subjects who dropped out for aforementioned reasons after month 30, one subject had a measured IOP of 11.0 mmHg, while the other’s was 16.5 mmHg at their final study visits. Neither subject required reintroduction of a topical agent prior to dropout. Hence, their dropout may have contributed to statistical underestimation of the 300 μg dose effect.” (opens the source at this quote in a new tab)

Cumulative adverse events through 36 months

Adverse event	75 μg, n = 8 (%)	150 μg, n = 8 (%)	300 μg, n = 7 (%)	Overall, n = 23 (%)
Blepharitis	“1 (12.5%)”	“0 (0.0%)”	“0 (0.0%)”	“1 (4.3%)”
Bacterial conjunctivitis	“1 (12.5%)”	“0 (0.0%)”	“0 (0.0%)”	“1 (4.3%)”
Conjunctival chemosis	“0 (0.0%)”	“1 (12.5%)”	“0 (0.0%)”	“1 (4.3%)”
Conjunctival hyperemia	“0 (0.0%)”	“1 (12.5%)”	“0 (0.0%)”	“1 (4.3%)”
Corneal laceration	“0 (0.0%)”	“1 (12.5%)”	“0 (0.0%)”	“1 (4.3%)”
Corneal scar	“0 (0.0%)”	“0 (0.0%)”	“1 (14.3%)”	“1 (4.3%)”
Dry eye	“4 (50.0%)”	“0 (0.0%)”	“1 (14.3%)”	“5 (21.7%)”
Intraoperative iris prolapse	“1 (12.5%)”	“0 (0.0%)”	“0 (0.0%)”	“1 (4.3%)”
Meibomian gland dysfunction	“0 (0.0%)”	“0 (0.0%)”	“1 (14.3%)”	“1 (4.3%)”
Photokeratitis	“0 (0.0%)”	“1 (12.5%)”	“0 (0.0%)”	“1 (4.3%)”
Subconjunctival hemorrhage	“0 (0.0%)”	“2 (25.0%)”	“0 (0.0%)”	“2 (8.7%)”
Transient BCDVA loss of ≥ 2 lines	“2 (25.0%)”	“0 (0.0%)”	“1 (14.3%)”	“3 (13.0%)”

Prostaglandin-class effects, implant stability, and serious events

“There were no cases of prostaglandin-associated periorbitopathy, no abnormal eyelash growth, and no cases of iris hyperpigmentation. There were no IOL dislocations, bimatoprost drug pad displacements, explantations, or reports of clinically significant posterior capsule opacification.” (opens the source at this quote in a new tab)
“No deaths or serious adverse events related to the implant occurred.” (opens the source at this quote in a new tab)

Corneal endothelial cell density and anterior chamber inflammation

“There was a reduction from a baseline of 2308 ± 223 cells/mm2 to 2068 ± 374 cells/mm2 (− 10.4%) by month 6 and 2013 ± 407 cells/mm2 (− 12.8%) by month 12.” (opens the source at this quote in a new tab)
“There was no anterior chamber inflammation observed in any subject’s study eye for the remainder of follow-up.” (opens the source at this quote in a new tab)

Sponsor summary of product-related adverse events

“All AEs that were observed were considered to be related to the cataract procedure and none were deemed to be associated with our product candidate.” (opens the source at this quote in a new tab)

Anterior chamber cell clearance at month 1

“Anterior chamber cell clearance at 1 month was 91.7%, a value within the range of cataract surgery with standard IOLs” (opens the source at this quote in a new tab)

Method used for the endothelial cell density measurements

“Although endothelial cell density measurements did not employ a validated reading center methodology, outcomes from automated measurements are reported.” (opens the source at this quote in a new tab)
“Further, corneal endothelial cell count data were not sufficiently reliable as they were derived directly from automated machine output and not verified by a reading center.” (opens the source at this quote in a new tab)

Summary

The long-term evidence comes from one sponsor-funded, single-surgeon, single-site cohort of 23 eyes in Honduras, with sequential unmasked dose assignment, no control group, and registration completed retrospectively in September 2025, after the 6-month pilot ended and 36-month follow-up was in progress. All participants were Hispanic or Latino with primary open-angle glaucoma, 87.0% were controlled on one medication before washout, and prior response to topical prostaglandin analogs was required. The study did not include a cataract-surgery-only comparator, although cataract extraction alone lowers IOP by 2 to 4 mmHg in glaucoma populations. Endothelial cell counts were automated without reading-center verification, and specular microscopy stopped after month 12. The authors state that the sponsor participated in design, analysis, and manuscript preparation, and that several authors are SpyGlass employees, consultants, or shareholders. The studied doses (75, 150, and 300 μg) differ from the Phase 3 dose (78 mcg).

Limitations stated by the authors

“This first-in-human study has important limitations, including small sample size, nonrandomized design, and selection of prior prostaglandin analogue responders.” (opens the source at this quote in a new tab)
“This criterion selected for eyes that would be more likely to benefit from the bimatoprost implant, possibly inflating efficacy metrics.” (opens the source at this quote in a new tab)
“As with any investigation that examines a technology paired with cataract extraction, one must consider the standalone 2–4 mmHg reduction achieved by the latter in glaucoma populations” (opens the source at this quote in a new tab)
“Retrospective registration of the current study increases risk for bias; outcomes should thus be interpreted cautiously.” (opens the source at this quote in a new tab)

Sponsor role in the publication

“The sponsor participated in the design of the study, conducting the study, data collection, data management, data analysis, interpretation of the data, preparation, and review and approval of the manuscript.” (opens the source at this quote in a new tab)

Registered study purpose

“The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination.” (opens the source at this quote in a new tab)

Publication aim

“This study aimed to explore the safety and efficacy of sustained release bimatoprost implant with SpyGlass intraocular lens (SpyGlass Pharma, Inc., Aliso Viejo, CA, USA).” (opens the source at this quote in a new tab)
“A placebo arm was not included because the current study was designed as a pilot to help guide dose selection for future research.” (opens the source at this quote in a new tab)

Study dates and site

Field	Registry record
Study start (actual)	“2022-04-21”
Primary completion (actual)	“2022-12-13”
Study completion (actual)	“2022-12-13”
First submitted	“2025-08-22”
Facility	“Centro Oftalmológico Robles”
City	“Santa Rosa de Copán”
Country	“Honduras”

Enrollment period and ethics approval

“The first patient was consented in April 2022, and the completion date of this initial pilot was December 2022.” (opens the source at this quote in a new tab)
“This nonrandomized, prospective, proof-of-concept interventional study was approved by the National Health Research Ethics Committee in El Salvador (CNEIS/2022/01H).” (opens the source at this quote in a new tab)

Registered design

“This is a single center, proof-of-concept, nonrandomized, multi-arm, controlled clinical trial with a 6-month participation period. The study consists of 3 cohorts of up to 10 participants each. Participants are assigned sequentially to cohorts using a nonrandomized intervention model.” (opens the source at this quote in a new tab)
“There was no masking in the study design, however, a 2-person reading method was used for all IOP measurements, wherein Observer 1 adjusts the dial and is masked to the reading on the dial and Observer 2 reads and records the value on the source documentation.” (opens the source at this quote in a new tab)

Design element	Registry record
Phase	“Not Applicable”
Allocation	“Non-Randomized”
Intervention model	“Parallel Assignment”
Masking	“Single”
Masked roles	“Outcomes Assessor”

Allocation and masking as published

“Participants were sequentially assigned by the local investigator (author MR) to receive either the low configuration (75 μg bimatoprost), medium configuration (150 μg), or high configuration (300 μg) of the product in a 1:1:1 allocation ratio. Neither subjects nor investigators were masked to assignments. Only one eye per subject was designated for treatment in the study.” (opens the source at this quote in a new tab)

Key inclusion criteria

Criterion	Quoted publication text
Age	“Male or female subjects at least 22 years of age”
Cataract	“Age-related cataract eligible for phacoemulsification, with BCDVA 20/30 or worse”
Medicated IOP	“Screening IOP ≤ 24 mmHg while on at least a prostaglandin analogue, with a stable medication regimen for ≥ 4 weeks”
Post-washout IOP	“Baseline unmedicated (post-washout) IOP ≥ 22 mmHg and ≤ 36 mmHg, and at least 3 mmHg higher than medicated screening IOP”
Optic disc	“Screening cup-to-disc ratio of 0.8 or less”
Angle anatomy	“Normal open-angle anatomy (Shaffer grade ≥ 2) by gonioscopy”

Key exclusion criteria

Criterion	Quoted publication text
Secondary glaucoma	“Pseudoexfoliation, pigmentary, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders”
Endothelium	“Central corneal endothelial cell count < 2000 cells/mm2 by specular microscopy”
Prior procedures	“History of incisional glaucoma surgery, argon laser trabeculoplasty, iridectomy, or iridotomy, or completion of selective laser trabeculoplasty within 90 days before screening”
Inflammation	“History of uveitis/iritis”
Macula	“History of macular edema”
IOL power	“Inability to receive an IOL ranging from 19 to 25 D”
Alpha-blockers	“Use of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) or similar medications”
Diabetic eye disease	“Diabetic retinopathy or diabetic maculopathy”
Hypersensitivity	“Subjects with known hypersensitivity or allergy to bimatoprost ophthalmic eye drops”

Prior prostaglandin response requirement

“All subjects were required to have responded to topical prostaglandin analogues.” (opens the source at this quote in a new tab)

Implant configuration and surgical procedure

“The studied drug delivery system consists of two silicone molded pads attached to an IOL (defined as the bimatoprost implant system). Each pad sits at the optic–haptic junction, contains a multiyear bimatoprost load, and delivers slow, continuous elution of bimatoprost with a near-zero-order delivery profile. Studied drug content selections include 75 μg, 150 μg, and 300 μg of bimatoprost.” (opens the source at this quote in a new tab)
“The postoperative regimen included a weekly taper of topical steroid/antibiotic combination from Q4H to Q6H to Q8H over a 3-week period. IOP-lowering drops were not reintroduced unless clinically necessary.” (opens the source at this quote in a new tab)

Relative daily release by dose

“Enrolled patients were sequentially assigned 1:1:1 into three groups, where patients received a BIM-IOL System containing 75, 150 or 300 mcg of bimatoprost that continuously released a low (1x), mid (2x) or high (4x) dose of bimatoprost per day, respectively.” (opens the source at this quote in a new tab)

Registered primary and secondary outcomes

Outcome type	Measure	Time frame
Primary	“Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6”	“From Baseline until the end of post-operative follow-up at Month 6”
Secondary	“Mean change in unmedicated IOP from Baseline to Month 6”	“From Baseline until the end of post-operative follow-up at Month 6”
Secondary	“Number of topical glaucoma medications”	“From Screening until the end of post-operative follow-up at Month 6”
Other	“Adverse Events”	“From Screening to the end of post-operative follow-up at Month 6”
Other	“Supplementary Safety Parameter - Specular Microscopy”	“From Baseline until the end of post-operative follow-up at Month 6”

Primary endpoint as published

“The primary endpoint was the proportion of unmedicated eyes with IOP reduction > 20% from baseline at month 6 and onward. Secondary outcomes included adverse events, mean changes in IOP, and mean changes in glaucoma medications.” (opens the source at this quote in a new tab)

Rationale for the 20% IOP reduction threshold

No evidence found.

Planned and enrolled participants

“The enrollment target was set at up to 30 subjects. Sample size was not calculated to attain pre-determined power for specified assumptions and type I error. Instead, the sample size was determined on the basis of ethical considerations, to adequately characterize safety across the three doses, and to obtain initial estimates of mean change-from-baseline IOPs with corresponding standard deviations.” (opens the source at this quote in a new tab)

Enrollment type	Participants
Actual	“24”

Analysis populations and significance threshold

“The statistical significance threshold was set at p < 0.05. Data were analyzed both on a per-protocol basis and with intention-to-treat analysis, by a trained statistician.” (opens the source at this quote in a new tab)
“When compared to the intention-to-treat IOP analysis through 6 months, outcomes were similar (Supplemental Table 2).” (opens the source at this quote in a new tab)

Screening, enrollment, and protocol deviation

“A total of 29 subjects were consented for the study from April through June 2022 (Fig. 2). Of those, four subjects failed either inclusion or exclusion criteria prior to surgery, and one withdrew consent prior to any study procedures being performed. The remaining 24 enrollees all received surgical interventions corresponding to their sequential assignments. Eight subjects per group received the low, medium, and high dose implants.” (opens the source at this quote in a new tab)
“No enrollees dropped out during the first 6 months of follow-up. At month 3 it was discovered that a single subject in the high dose implant cohort had preexisting diabetic retinopathy. This subject should have failed eligibility criteria prior to surgery (Table 1) but was followed for safety until referral to the retina clinic.” (opens the source at this quote in a new tab)

Baseline characteristics as published

“Mean age was 70.5 ± 9.6 years, with a near-equal gender ratio. All subjects were of Hispanic/Latino ethnicity and Caucasian race, and all were diagnosed with primary open-angle glaucoma (POAG) with a mean vertical cup-to-disc ratio of 0.6 ± 0.2. Median BCDVA prior to cataract surgery was 20/50.” (opens the source at this quote in a new tab)
“Target pressures for most subjects were achieved preoperatively on a single ocular hypotensive agent (n = 20, 87.0%), while the remainder required two or three. Prior to medication washout, mean IOP was 16.5 ± 3.5 mmHg. Post-washout mean IOP was 25.1 ± 2.5 mmHg.” (opens the source at this quote in a new tab)

Primary endpoint at month 6

“By week 1, all groups achieved mean IOP reductions exceeding 40% (p < 0.05 all).” (opens the source at this quote in a new tab)
“At month 6, every individual study eye achieved an unmedicated IOP reduction ≥ 20% versus baseline.” (opens the source at this quote in a new tab)

IOP at months 3 and 6 by dose cohort (per-protocol)

Cohort	Baseline IOP, mean mmHg ± SD	Month 3 IOP, mean mmHg ± SD	Month 6 IOP, mean mmHg ± SD	Month 3 % reduction	Month 6 % reduction
75 μg (n = 8)	“24.6 ± 2.1”	“12.4 ± 1.9”	“12.7 ± 2.5”	“49.3 ± 7.2”	“48.4 ± 9.3”
150 μg (n = 8)	“25.6 ± 3.3”	“13.9 ± 2.7”	“14.4 ± 3.2”	“45.5 ± 9.8”	“43.2 ± 12.3”
300 μg (n = 7)	“25.0 ± 1.8”	“14.3 ± 2.4”	“14.3 ± 3.0”	“42.8 ± 9.2”	“42.8 ± 11.9”
Overall (n = 23)	“25.1 ± 2.5”	“13.5 ± 2.4”	“13.8 ± 2.9”	“46.0 ± 8.8”	“44.9 ± 11.0”

Change from baseline and between-cohort comparison at months 3 and 6

Measure	Month 3	Month 6
Overall CFB IOP, mean mmHg ± SD	“− 11.6 ± 2.8”	“− 11.3 ± 3.1”
p value (CFB = 0)	“< 0.0001”	“< 0.0001”
p value (CFB among Tx)	“0.65”	“0.72”

Intraoperative and early postoperative findings

“All procedures were uncomplicated except for a single subject in the low dose cohort who experienced mild iris prolapse into the main incision after anterior chamber overinflation; the iris appearance had normalized without sequelae on scheduled follow-up.” (opens the source at this quote in a new tab)
“Regarding postoperative changes, mild corneal edema was noted in 13 study eyes at day 1 (56.5%). This decreased to a single eye (4.3%) by week 1. At all subsequent visits, no corneal edema was reported.” (opens the source at this quote in a new tab)
“At postoperative month 1, only two subjects (8.7%) had faint anterior chamber cells in their study eyes; all other study eyes were clear.” (opens the source at this quote in a new tab)

Transient visual acuity loss at month 1

“Temporary loss of ≥ 2 Snellen lines occurred in the study eyes of three subjects, each at the month 1 visit. Two were attributed to ocular surface disease and responded to topical drops by subsequent visits.” (opens the source at this quote in a new tab)
“The third instance had no associated ocular findings and self-resolved by the next visit.” (opens the source at this quote in a new tab)

Early postoperative IOP spikes

“Further, no eye had an early postoperative IOP spike that required the addition of medication.” (opens the source at this quote in a new tab)

Summary

SGP-SPEC-001 was a 6-month, single-site, nonrandomized, unmasked dose-exploration pilot in 24 participants, registered on ClinicalTrials.gov in August to September 2025, almost 3 years after its December 2022 completion. The authors did not calculate sample size for statistical power, and one enrolled participant with preexisting diabetic retinopathy should have been excluded before surgery. Only prior responders to topical prostaglandin analogs were eligible, all participants had primary open-angle glaucoma (none had ocular hypertension), and the IOL power range was limited to 19.0 to 25.0 D. No dose-response relationship was observed: month-6 IOP change did not differ among cohorts (p = 0.72), and the doses tested (75, 150, 300 μg) are not the Phase 3 dose (78 mcg). The registry describes the trial as "controlled," although no control group was enrolled.

Limitations stated by the authors

“A small, nonrandomized sample with no control group greatly limits validity and may have contributed to underestimation of adverse effects.” (opens the source at this quote in a new tab)
“The single-site design with a sample comprised entirely of white Latino patients with POAG further limits generalizability to wider populations. Procedures were performed by a single ophthalmologist; given that cataract surgery approaches vary, other operators may realize challenges with a new product.” (opens the source at this quote in a new tab)
“Most subjects required only a single glaucoma medication prior to washout; as such, it is less clear how this product would perform for more recalcitrant glaucomas.” (opens the source at this quote in a new tab)