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.