SGP-005 (Rhine)

20 evidence topics · 4 sources

Objective

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)

Location and study date

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)

Study design

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)

Eligibility criteria

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)

Treatment

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)

Study outcomes

Rationale for using time-matched mean IOP change from baseline and BCDVA of 20/40 or better as the co-primary endpoints

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.

Statistical analysis description

Number of participants (Planned and analyzed)

Planned enrollment

Enrollment type	Participants
Estimated	“400”

Analyzed population

No evidence found.

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

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.