EyePoint, Inc. Completes Full Enrollment of Pivotal Phase 3 Trials for DURAVYU™ in Diabetic Macular Edema
Key Highlights
- EyePoint, Inc. (Nasdaq: EYPT) has completed enrollment of its two pivotal Phase 3 clinical trials—COMO and CAPRI—evaluating DURAVYU™ (vorolanib intravitreal insert) for Diabetic Macular Edema (DME).
- Over 480 patients were enrolled across both trials, achieving full enrollment ahead of schedule in just five months.
- Topline 56-week data are anticipated in Q4 2027.
- DURAVYU is being positioned as a potential first-to-market sustained-release therapy for the two largest retinal disease markets: DME and wet age-related macular degeneration (wet AMD).
- Phase 3 data for wet AMD are expected starting August 2026.
Detailed Report
EyePoint, Inc., a clinical-stage biopharmaceutical company focused on innovative retinal disease therapies, announced a significant milestone with the completion of patient enrollment in its two pivotal Phase 3 trials, COMO and CAPRI, for DURAVYU™ in Diabetic Macular Edema (DME). The rapid recruitment of over 480 participants, completed ahead of schedule in five months, signals robust enthusiasm among both investigators and patients for this investigational therapy.
Trial Design and Competitive Positioning:
- Both COMO and CAPRI are global, randomized, double-masked, non-inferiority trials comparing DURAVYU 2.7mg (administered via a single intravitreal injection every six months) to the current standard of care, 2mg aflibercept (Eylea), in both treatment-naïve and previously treated DME patients.
- The primary endpoint is a non-inferior change from baseline in best corrected visual acuity (BCVA) at weeks 52 and 56 (blended), compared to aflibercept. Secondary endpoints include safety, superiority in reducing treatment burden, percentage of eyes free of supplemental aflibercept injections, and anatomical changes as measured by optical coherence tomography (OCT).
- DURAVYU offers a differentiated, sustained-release approach using proprietary Durasert E™ technology, aiming to reduce the frequency of injections and overall treatment burden for patients and providers.
Clinical and Market Implications:
- DME is the second largest retinal disease market globally, affecting approximately 28 million people and representing a significant unmet need due to the chronic under-treatment associated with frequent intravitreal injections.
- The rapid and enthusiastic enrollment underscores excitement in the retina community for a therapy that could offer both durable efficacy and a more patient-friendly dosing schedule (every six months versus current monthly or bimonthly regimens).
- Positive feedback on trial design from both the FDA and EMA supports the regulatory alignment and potential for global approval.
Safety, Efficacy, and Differentiation:
- DURAVYU targets multiple disease mechanisms, inhibiting all VEGF receptors, PDGFR, and IL-6/JAK1 signaling, potentially offering improved outcomes over existing anti-VEGF therapies.
- Phase 2 studies (VERONA for DME and DAVIO/DAVIO-2 for wet AMD) demonstrated early and sustained improvements in both vision and retinal anatomy, with a favorable safety profile and no significant safety signals in over 190 patients treated to date.
- An independent Data Safety Monitoring Committee (DSMC) recommended continuation of all ongoing Phase 3 programs without modifications following a safety review in May 2026.
Upcoming Catalysts for Investors:
- Topline data from the ongoing Phase 3 wet AMD trials (LUGANO and LUCIA) expected beginning August 2026.
- Topline data from the Phase 3 DME trials (COMO and CAPRI) anticipated in Q4 2027.
- These data readouts represent major value inflection points and potential share price catalysts if positive.
Important Shareholder Considerations & Potential Price Sensitivity
- Completion of pivotal trial enrollment ahead of schedule is a positive operational achievement and may indicate strong regulatory and clinical momentum.
- If DURAVYU demonstrates non-inferior or superior efficacy and safety to aflibercept, it could disrupt the DME and wet AMD markets, supporting significant commercial potential.
- Regulatory milestones are closely watched; any delays, negative data, or regulatory setbacks could materially impact share value.
- The company’s Northbridge, MA manufacturing site will be critical for commercial launch, and any regulatory or operational issues at this facility could pose risks.
- EyePoint’s cash runway, partnership strategy, and ability to scale up for commercial launch are also key factors for investors to monitor.
About DURAVYU™
DURAVYU is an investigational, sustained-delivery intravitreal insert containing vorolanib, a selective tyrosine kinase inhibitor, in a bioerodible matrix designed for at least six months of drug release. The product is being evaluated for both DME and wet AMD, with the potential to be the first sustained-release therapy targeting both VEGF and inflammatory pathways. It is not yet FDA-approved. Vorolanib is licensed from Equinox Sciences for use outside of China, Macao, Hong Kong, and Taiwan.
About EyePoint, Inc.
EyePoint is a clinical-stage biopharmaceutical company with a track record of four approved ophthalmic drugs over three decades. The company is based in Watertown, MA, with a commercial manufacturing facility in Northbridge, MA.
Forward-Looking Statements & Disclaimer
This article contains forward-looking statements based on current information, management’s expectations, and estimates. Actual results may differ materially due to various risks and uncertainties, including clinical development outcomes, regulatory approval timelines, manufacturing readiness, market competition, and changes in economic or business conditions. Investors should review the company’s filings with the SEC for a full discussion of risk factors. This article is for informational purposes only and does not constitute investment advice. Please consult your financial advisor before making investment decisions.
