EyePoint Completes Enrollment in Phase 3 Duravyu Trials for Diabetic Macular Edema Ahead of Schedule

EyePoint Reaches Major Clinical Development Milestone

EyePoint, Inc. has announced that it has completed patient enrollment in its two global Phase 3 clinical trials, COMO and CAPRI, evaluating Duravyu (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME).

The company enrolled more than 480 patients across both studies, completing recruitment ahead of schedule in just five months.

EyePoint expects topline results from both Phase 3 studies during the fourth quarter of 2027.

Fast Enrollment Reflects Strong Interest in the Program

According to the company, completing enrollment earlier than expected highlights the strong execution of its clinical development team as well as growing interest from investigators and patients.

Jay S. Duker, President and Chief Executive Officer of EyePoint, said the rapid enrollment supports the company's confidence in Duravyu as a potentially longer-lasting treatment option for diabetic macular edema.

He also noted that the positive safety and efficacy data generated so far, along with constructive feedback from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), continue to support the advancement of the program toward the next stage of development.

What the COMO and CAPRI Studies Are Evaluating

COMO and CAPRI are global, randomized, double-masked, Phase 3 clinical trials comparing Duravyu with the standard 2 mg aflibercept treatment.

The studies include both newly diagnosed patients and individuals who have previously received treatment for diabetic macular edema.

Participants are randomly assigned to receive either:

• Duravyu 2.7 mg administered once every six months.
• Standard 2 mg aflibercept treatment.

Duravyu is delivered through a single intravitreal injection performed in a physician's office using a procedure similar to currently approved retinal injections.

Researchers will primarily measure changes in best corrected visual acuity (BCVA) at Weeks 52 and 56 to determine whether Duravyu performs as well as aflibercept.

Additional study endpoints include patient safety, reduction in treatment burden, the number of patients who remain free from supplemental aflibercept injections, and retinal anatomy improvements measured using optical coherence tomography (OCT).

Retina Specialists See Strong Potential

Dr. Veeral Sheth, Partner and Director of Clinical Research at University Retina and Macula Associates, said diabetic macular edema patients often receive fewer treatments than they need because current therapies require frequent injections.

He explained that results from earlier studies have shown encouraging improvements in vision and retinal anatomy while maintaining a favorable safety profile.

According to Dr. Sheth, Duravyu's ability to deliver medicine over an extended period while targeting multiple disease pathways could provide longer-lasting treatment benefits for patients.

The quick enrollment of both studies also reflects growing excitement within the retina community.

Safety Monitoring Supports Continued Development

EyePoint also reported that an independent Data Safety Monitoring Committee reviewed masked safety information from the company's ongoing Phase 3 studies in both diabetic macular edema and wet age-related macular degeneration.

Following the review in May 2026, the committee recommended that both development programs continue without any protocol changes.

To date, Duravyu has been studied in more than 190 patients across four completed clinical trials.

The company says no treatment-related safety concerns have been identified during those studies.

Earlier Studies Helped Shape the Phase 3 Program

The current Phase 3 studies were designed using data collected from the Phase 2 VERONA clinical trial.

In that study, Duravyu demonstrated:

• Early improvements in visual acuity.
• Sustained vision gains.
• Approximately two-thirds reduction in treatment burden compared with aflibercept.
• Longer time before patients required supplemental injections.
• Improvements in central subfield thickness.

The overall Phase 3 program was developed in collaboration with both US and European regulatory authorities.

Many of the clinical sites participating in EyePoint's wet age-related macular degeneration studies are also involved in the diabetic macular edema program, helping accelerate enrollment.

Understanding Diabetic Macular Edema

Diabetic macular edema is one of the leading causes of vision loss in people living with type 1 and type 2 diabetes.

The condition develops when damaged blood vessels leak fluid into the macula, the part of the retina responsible for sharp central vision.

As fluid builds up, the retina swells, causing blurred vision that may eventually progress to severe vision loss or blindness.

Researchers believe the disease is driven not only by vascular endothelial growth factor (VEGF), but also by platelet-derived growth factor (PDGF) and inflammatory pathways involving interleukin-6 (IL-6).

Around 28 million people worldwide are affected by diabetic macular edema, and the number continues to increase as diabetes becomes more common.

Current treatment usually requires repeated anti-VEGF injections, corticosteroids, or laser treatment, creating a significant burden for patients, caregivers, and physicians.

How Duravyu Is Different

Duravyu is an investigational sustained-release treatment designed for serious retinal diseases.

The therapy combines vorolanib, a selective tyrosine kinase inhibitor, with EyePoint's proprietary Durasert E sustained drug delivery technology.

The insert is designed to release medicine continuously for at least six months after a single injection without leaving free-floating drug particles inside the eye.

Unlike traditional anti-VEGF therapies that block VEGF outside the cell, vorolanib works inside cells.

It blocks all VEGF receptors and PDGF receptors while also reducing inflammation through inhibition of IL-6 and JAK1 signaling.

This multi-mechanism approach may provide longer-lasting disease control while reducing the number of injections patients require.

Development Continues Across Multiple Retinal Diseases

In addition to diabetic macular edema, Duravyu is also being developed for wet age-related macular degeneration (wet AMD).

EyePoint has already completed enrollment in its Phase 3 LUGANO and LUCIA studies, which include more than 900 patients.

Those studies are evaluating six-month dosing intervals and are expected to begin reporting data in August 2026.

For diabetic macular edema, the newly completed enrollment in COMO and CAPRI moves the program one step closer to Phase 3 data expected during the fourth quarter of 2027.