Bimatoprost Implant System for Glaucoma

Overseen By Director, Clinical Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: SpyGlass Pharma, Inc.

Disqualifiers: Uncontrolled systemic disease, other ocular diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with mild to moderate open-angle glaucoma or ocular hypertension who plan to undergo cataract surgery. It compares a new Bimatoprost Implant System (an implant for managing eye pressure) combined with a special lens to the standard eye drop treatment, Timolol Solution. The trial aims to determine which option better manages eye pressure. Ideal candidates for this trial have glaucoma or ocular hypertension, require cataract surgery, and do not have other eye diseases. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Bimatoprost Implant System is safe for treating open-angle glaucoma and high eye pressure. Studies have found that one implant can lower eye pressure for up to a year, potentially reducing the need for eye-drop medications.

The treatment is generally well-tolerated, though some patients have noticed changes in eye color and darkening of eye tissues. These side effects are usually not harmful, but awareness is important. Overall, evidence suggests that the Bimatoprost Implant System is a safe option for managing eye pressure. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Bimatoprost Implant System is unique because it offers a new delivery method for treating glaucoma. Unlike traditional eye drops, such as Timolol Maleate, this implant provides a continuous release of medication directly inside the eye. This method not only ensures consistent drug delivery but also potentially improves patient compliance by eliminating the need for daily eye drops. Researchers are excited about this treatment because it targets intraocular pressure more efficiently, possibly leading to better long-term outcomes for patients.

What evidence suggests that the Bimatoprost Implant System might be an effective treatment for glaucoma?

Research has shown that the Bimatoprost Implant System, a treatment in this trial, helps lower eye pressure, which is crucial for treating open-angle glaucoma and high eye pressure. In several studies, the implant effectively reduced eye pressure for up to a year and decreased the need for additional eye-drop medications. One study found that the Bimatoprost Implant worked as well as Selective Laser Trabeculoplasty (SLT) in lowering eye pressure. These results suggest that the implant is a promising option for individuals with mild to moderate open-angle glaucoma or high eye pressure. Participants in this trial may receive the Bimatoprost Implant System combined with an IOL, while others will receive Timolol Maleate Ophthalmic Solution 0.5% as a comparator. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul Yoo, OD

Principal Investigator

SpyGlass Pharma

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate open-angle glaucoma or ocular hypertension who are also undergoing cataract surgery. Specific eligibility criteria details were not provided, so interested participants should inquire further.

Inclusion Criteria

I have been diagnosed with mild to moderate open-angle glaucoma or high eye pressure.

I am scheduled for cataract surgery.

I am a woman who can have children, tested negative for pregnancy, and agree to use birth control.

Exclusion Criteria

I have other eye diseases or conditions.

I have had surgery to correct my vision.

I have a type of glaucoma that is not OHT, open-angle, pseudoexfoliative, or pigmentary.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Bimatoprost Implant System with SpyGlass IOL or Timolol Maleate Ophthalmic Solution

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bimatoprost Implant System
• Commercial IOL

Trial Overview The study compares the Bimatoprost Implant System combined with SpyGlass IOL against Timolol Ophthalmic Solution in patients. It's a randomized trial, meaning participants are randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: Bimatoprost Implant System / IOL Combination Experimental Treatment 2 Interventions

Group II: Timolol Maleate Ophthalmic Solution 0.5% Active Control 2 Interventions

Who Is Running the Clinical Trial?

SpyGlass Pharma, Inc.

Lead Sponsor

Trials

1

Recruited

200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10804876/

Real-World Study of the Effectiveness and Safety ... A single bimatoprost implant administration safely and effectively reduced IOP for up to 1 year and decreased the need for topical IOP-lowering medications.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772632025000273

Efficacy of bimatoprost sustained-release implant in ... In summary, the study's findings indicate that the bimatoprost implant effectively and safely treats open-angle glaucoma (OAG) by reducing intraocular pressure ...

3. ajo.com ajo.com/article/S0002-9394(25)00003-0/fulltext

Phase 3, Randomized, Comparison Study of Intracameral ... The bimatoprost implant demonstrated statistical and clinical noninferiority to SLT in IOP reduction from baseline at weeks 4, 12, and 24. In ...

4. link.springer.com link.springer.com/article/10.1007/s40265-025-02157-1

Prospective 18-Month Study of Bimatoprost Intracameral ... The purpose of this study was to prospectively collect effectiveness and safety data after administration of the implant in patients with open-angle glaucoma ...

5. aaojournal.org aaojournal.org/article/S0161-6420%2820%2930555-8/fulltext

Phase 3, Randomized, 20-Month Study of Bimatoprost ... The effects of bimatoprost implant on IOP were similar after repeated administration. Both dose strengths of bimatoprost implant demonstrated statistical and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07154810

NCT07154810 | Observational Study to Evaluate Long ... Observational Study to Evaluate Long Term Outcomes for Ocular Hypertension and Glaucoma Patients Treated With the SpyGlass Bimatoprost Implant ...

7. durystahcp.com durystahcp.com/clinical-data

Clinical Data Ophthalmic bimatoprost, including DURYSTA intracameral implant, has been reported to cause changes to pigmented tissues, such as increased pigmentation of the ...