Durysta for Glaucoma

Overseen By Giana Ilarraza

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must be taking: Topical glaucoma medications

Must not be taking: Immunosuppressors, Immunomodulators

Disqualifiers: Retinal disease, Conjunctivitis, Corneal transplant, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if Durysta, a tiny capsule with medicine injected into the eye, can reduce eye inflammation in people with glaucoma. Specifically, it examines whether this long-lasting treatment, which reduces the need for daily eye drops, helps with inflammation. This trial may suit individuals with open-angle glaucoma who regularly use eye drops but still face issues. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.

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

The trial does not specify if you need to stop your current medications, but it seems you need to be on certain glaucoma medications to participate. If you are using immunosuppressor or immunomodulator drugs, you cannot join the trial.

What is the safety track record for Durysta?

Research shows that Durysta, a bimatoprost implant, has been studied for its safety and effectiveness in lowering eye pressure in people with glaucoma. Studies have found that one implant can safely reduce eye pressure for up to a year, potentially reducing the need for other eye pressure-lowering medications.

However, some studies have noted that the implants can cause issues with the cornea, the clear front part of the eye, including possible side effects and a risk of losing some corneal cells. Despite these concerns, patients have generally reported positive experiences, and the overall safety is considered acceptable.

Durysta is in a Phase 4 trial, indicating that the FDA has already approved the treatment for use in people. This suggests that while some risks exist, the benefits are well-understood and monitored. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for glaucoma, which often involve daily eye drops like prostaglandin analogs or beta-blockers, Durysta offers a unique approach with its one-time intracameral administration. This delivery method means the medication is placed directly in the eye, potentially reducing the need for daily compliance and minimizing systemic side effects. Researchers are excited about Durysta because it uses bimatoprost, a proven active ingredient, in a sustained-release format that might provide long-term pressure reduction with a single treatment. This could significantly improve convenience and quality of life for patients managing their eye pressure.

What is the effectiveness track record for Durysta in treating glaucoma?

Research has shown that Durysta, a tiny implant, effectively lowers eye pressure in people with glaucoma. Studies have found it can reduce this pressure by about 5 to 8 mm Hg, which is crucial for managing the condition. Over 18 months, about 78% of eyes treated with the implant did not require additional medications. This indicates that Durysta not only lowers eye pressure but also reduces the need for other eye-drop medicines. These results instill confidence in its ability to help people with open-angle glaucoma. ^{1 2 3 4 6}

Who Is on the Research Team?

Swarup S Swaminathan, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for people with open-angle glaucoma or suspected of it, who have had at least 6 months of treatment with up to 3 daily eye drops including a preserved prostaglandin analog (PGA) at night. Participants must show signs of corneal damage and be good at following their medication routine. Those with certain retinal diseases, using immunosuppressors, having recent eye surgery or transplants, or using preservative-free glaucoma medications cannot join.

Inclusion Criteria

I have or might have open-angle glaucoma.

I have a lens implant in my eye and significant eye inflammation.

I've been using 3 or fewer glaucoma eye drops daily for over 6 months.

Exclusion Criteria

I have a serious eye condition like wet AMD, diabetic retinopathy, or CRVO.

I am not using any immune system affecting drugs like steroids.

I use eye drops without preservatives for high eye pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intracameral administration of Durysta - bimatoprost 10mcg

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ocular surface inflammation and other secondary outcomes

3 months

Multiple visits (in-person) at 1 month and 3 months post-injection

What Are the Treatments Tested in This Trial?

Interventions

• Durysta

Trial Overview The study tests if switching from regular eye drops to Durysta—a sustained release capsule injected into the eye—reduces inflammation on the ocular surface. This is measured by checking levels of caspase-1, an inflammatory marker in the eyes.

How Is the Trial Designed?

Group I: Durysta Experimental Treatment 1 Intervention

Participants will receive a one-time intracameral administration of Durysta - bimatoprost 10mcg

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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. durystahcp.com durystahcp.com/clinical-data

Clinical Data In clinical studies, DURYSTA® demonstrated an IOP reduction of approximately 5 to 8 mm Hg in patients with a mean baseline IOP of 24.5 mm Hg. Please see below ...

3. 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 ...

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

Prospective 18-Month Study of Bimatoprost Intracameral ... Throughout the 18 months after implant administration, an estimated 77.7% of eyes required no new added medication for IOP management. Patient- ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39946034/

Prospective 18-Month Study of Bimatoprost Intracameral ... Intraocular pressure was reduced after implant administration, with mean changes in IOP from baseline at follow-up visits ranging from - 1.0 to ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0002939425000030

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 ...