EyePoint completed enrollment in the Phase 3 COMO and CAPRI trials evaluating DURAVYU for diabetic macular edema, with topline data expected in Q4 2027.
Written By: Rishabh Sonawane, BPharm
Reviewed By: Pharmacally Editorial Team
EyePoint Pharmaceuticals has completed patient enrollment in the pivotal Phase 3 COMO (NCT07449936) and CAPRI (NCT07449923) clinical trials evaluating DURAVYU™ (vorolanib intravitreal insert) for diabetic macular edema (DME). More than 480 patients were enrolled across the two global studies within five months, completing enrollment ahead of schedule. Topline efficacy and safety results from both trials are expected in the fourth quarter of 2027. DURAVYU is EyePoint’s investigational sustained-release intravitreal insert based on the company’s Durasert E™ delivery platform.
Phase 3 Trial Design
The randomized, double-masked, non-inferiority COMO and CAPRI studies compare DURAVYU 2.7 mg with aflibercept 2 mg in treatment-naïve and previously treated patients with DME. The primary endpoint is the blended change in best-corrected visual acuity (BCVA) at Weeks 52–56. Secondary endpoints include safety, treatment burden, need for supplemental aflibercept injections, and retinal anatomical outcomes assessed by optical coherence tomography (OCT). According to EyePoint, the rapid enrollment reflects strong investigator engagement with the trial program, which was developed following interactions with the FDA and EMA.
Supporting Clinical Evidence
The Phase 3 program is supported by the Phase 2 VERONA trial (NCT06099184), in which DURAVYU was associated with early and sustained improvements in BCVA, an approximately two-thirds reduction in treatment burden, prolonged time to first supplemental anti-VEGF injection, and favorable retinal anatomical outcomes compared with aflibercept.
These findings provided the clinical rationale for advancing DURAVYU into the pivotal Phase 3 COMO and CAPRI trials. The studies are designed to demonstrate non-inferior visual outcomes compared with aflibercept while evaluating whether DURAVYU’s sustained-release design can maintain efficacy with approximately six-month dosing, potentially reducing treatment burden and the need for frequent intravitreal injections.
An independent Data Safety Monitoring Committee recommended continuation of the ongoing Phase 3 DME and wet age-related macular degeneration (AMD) studies without protocol modifications. Across four completed clinical trials involving more than 190 patients, DURAVYU has shown a favorable safety profile with no new treatment-related safety signals.
Executive Perspective
EyePoint President and CEO Dr. Jay S. Duker said the ahead-of-schedule enrollment reflects strong investigator engagement and highlighted that interactions with both the FDA and EMA helped inform the current Phase 3 trial design.
About Diabetic Macular Edema
Diabetic macular edema is a leading cause of vision loss among people with diabetes. The condition develops when damaged retinal blood vessels leak fluid into the macula, leading to retinal swelling and impaired central vision. Current standard treatment typically requires frequent intravitreal anti-VEGF injections, creating a substantial long-term treatment burden.
How DURAVYU Works
DURAVYU is an investigational sustained-release intravitreal insert combining vorolanib, a selective tyrosine kinase inhibitor, with EyePoint’s bioerodible Durasert E™ delivery technology designed to release drug for at least six months. Unlike anti-VEGF biologics that neutralize extracellular VEGF, vorolanib acts intracellularly by inhibiting VEGF and PDGF receptor signaling while also suppressing IL-6/JAK1 inflammatory signaling. This dual approach is intended to address both angiogenesis and inflammation while reducing injection frequency.
Current anti-VEGF therapies often require injections every four to eight weeks. If successful, a sustained-release therapy capable of maintaining efficacy with dosing every six months could reduce treatment burden and improve long-term treatment adherence.
Path Forward
EyePoint is also evaluating DURAVYU in two pivotal Phase 3 trials for wet AMD. The company expects topline data from the wet AMD program beginning in August 2026, followed by topline DME results in the fourth quarter of 2027. DURAVYU has received FDA conditional acceptance of its proprietary name and remains an investigational therapy that has not yet been approved.
What This Means for Patients
If approved, DURAVYU could provide a longer-lasting treatment option requiring dosing approximately every six months, potentially reducing clinic visits and the burden of repeated intravitreal injections. However, its efficacy and safety must first be confirmed in the ongoing Phase 3 studies and subsequent regulatory review.
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About the Writer
Rishabha Sonawane, B.Pharm (LinkedIn) is healthcare writer with a strong interest in medical writing, regulatory affairs, clinical research, and AI-driven drug discovery. He has completed specialized training from the NIH and ICMR in clinical pharmacology, clinical research, and scientific writing. Passionate about evidence-based healthcare communication, he focuses on translating complex scientific research into clear, accurate, and engaging medical content.