Bimatoprost Implant + SpyGlass Lens for Glaucoma/Ocular Hypertension

(Tigris Trial)

Overseen By Chris Hafner

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

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)

Compensation: Varies

Number of Visits: 2

Duration: 36 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment using the Bimatoprost Implant (a type of eye implant) combined with a special lens called SpyGlass can benefit individuals with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery. Researchers are comparing two different doses of this new treatment against a standard eye drop, Timolol, to identify the most effective option. Individuals with open-angle glaucoma or high eye pressure who plan to have cataract surgery might be suitable candidates for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking advancements in eye care.

Will I have to stop taking my current medications?

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 generally safe for people. Studies indicate that both high and low doses of the implant effectively lower eye pressure in patients with open-angle glaucoma or high eye pressure. The implants have been safely used for up to a year, often reducing the need for other treatments to lower eye pressure.

For the high dose, earlier studies found that a single implant was safe and effective in reducing eye pressure for a long time. The low dose also showed similar results, with patients experiencing a significant drop in eye pressure and good tolerance.

In summary, while the current trial is in its early stages, previous studies provide promising evidence about the safety of the Bimatoprost Implant System in managing eye pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Bimatoprost Implant System for glaucoma and ocular hypertension because it offers a novel approach by delivering medication directly within the eye through an implant. Unlike traditional eye drops like Timolol Maleate, which require daily application and can be difficult for some patients to use consistently, the implant provides a steady release of medication over time, potentially improving adherence and effectiveness. Additionally, the implant’s use of Bimatoprost, a prostaglandin analog, targets fluid buildup in the eye to lower intraocular pressure, which is crucial in managing these conditions. This innovative delivery method could reduce the burden of daily medication and enhance patient outcomes.

What evidence suggests that this trial's treatments could be effective for glaucoma or ocular hypertension?

Research has shown that the Bimatoprost Implant System, in both high and low doses, effectively lowers eye pressure. In this trial, participants may receive either the high-dose or low-dose Bimatoprost Implant System combined with an intraocular lens (IOL). One study found that the implant significantly reduced eye pressure compared to a placebo, with an average difference of –1.53 mmHg. Another study found that some patients did not need any other treatments to lower eye pressure for up to 18 months after receiving the implant. The implant has also demonstrated effectiveness comparable to other treatments like laser therapy. These findings suggest that the Bimatoprost Implant could be a promising option for managing glaucoma and high eye pressure. ^{1 2 3 5 6}

Who Is on the Research Team?

Chris Hafner

Principal Investigator

SpyGlass Pharma, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate open-angle glaucoma or ocular hypertension who are also undergoing cataract surgery. Participants must not have other types of glaucoma, uncontrolled diseases, a history of certain eye surgeries, or additional eye conditions.

Inclusion Criteria

I am scheduled for cataract surgery.

I am a woman who can have children, not pregnant, and agree to use birth control.

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

Exclusion Criteria

I have no other eye diseases or conditions.

I have had surgery for glaucoma or injections in my eye.

I have a disease that is not currently under control.

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 in combination with the SpyGlass IOL or Timolol Ophthalmic Solution

36 months

Regular visits at Weeks 2 and 6, and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimatoprost Implant System (High Dose)
• Bimatoprost Implant System (Low Dose)
• Timolol Maleate Ophthalmic Solution, 0.5%

Trial Overview

The study compares two doses of the Bimatoprost Implant System combined with SpyGlass IOL against Timolol Ophthalmic Solution in patients having cataract surgery and living with specific types of glaucoma or high eye pressure.

How Is the Trial Designed?

Group I: Bimatoprost Implant System (Low Dose) / IOL Combination Experimental Treatment 2 Interventions

Group II: Bimatoprost Implant System (High Dose) / IOL Combination Experimental Treatment 2 Interventions

Group III: 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+

Published Research Related to This Trial

In a study of 606 patients with primary open-angle glaucoma or ocular hypertension, the fixed combination of bimatoprost 0.03% and timolol 0.5% significantly lowered intraocular pressure (IOP) from a baseline of 20.7 mmHg to 16.1 mmHg after 12 weeks, demonstrating a reduction of 22.2%.

The treatment was well tolerated, with 98.7% of physicians and 96.7% of patients rating its tolerability as excellent or good, and only a few adverse events were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. Feuerhake, C., Buchholz, P., Kimmich, F.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11891102/

Prospective 18-Month Study of Bimatoprost Intracameral ...

The bimatoprost implant helped control IOP and decrease topical medication use. Throughout the 18 months after implant administration, an ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772632025000273

Efficacy of bimatoprost sustained-release implant in ...

Pooled analysis demonstrated that the bimatoprost SR implant significantly reduced IOP compared to placebo, with a mean difference of –1.53 mmHg. The implant ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11947067/

Interim Analysis of a Phase 3b Clinical Trial (TRITON) - PMC

In this analysis of interim data from the TRITON study, the bimatoprost implant provided a long duration of IOP management without use of IOP- ...

4.

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 ...

5.

ajo.com

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

Phase 3, Randomized, Comparison Study of Intracameral ...

This study compared bimatoprost implant with selective laser trabeculoplasty (SLT). Up to 2 implants lowered intraocular pressure (IOP) as effectively as ...

6.

dovepress.com

dovepress.com/real-world-study-of-the-effectiveness-and-safety-of-intracameral-bimat-peer-reviewed-fulltext-article-OPTH

Effectiveness and Safety of Intracameral Bimatoprost Implant

Conclusion: A single bimatoprost implant administration safely and effectively reduced IOP for up to 1 year and decreased the need for topical ...