EyePoint Reports Positive Six-Month Phase 2 VERONA Trial Results for DURAVYU™ in Diabetic Macular Edema

EyePoint Pharmaceuticals, based in Watertown, Massachusetts, has announced promising results from its Phase 2 VERONA clinical trial of DURAVYU™ (vorolanib intravitreal insert). This investigational therapy is intended for sustained delivery in the treatment of diabetic macular edema (DME), a leading cause of vision loss among working-age adults. DURAVYU, which utilizes EyePoint's proprietary bioerodible Durasert E™ technology, has shown significant clinical benefits in this trial.

The Phase 2 VERONA study evaluated two doses of DURAVYU, 1.34mg and 2.7mg, against a control treatment of aflibercept. The primary objective of the trial was to extend the time to the first supplemental injection, a goal achieved by both DURAVYU doses. Notably, the 2.7mg dose of DURAVYU demonstrated a marked improvement in best corrected visual acuity (BCVA) with an increase of +7.1 letters and a 76-micron reduction in central subfield thickness (CST) at week 24. This was paired with a reduction in treatment burden by two-thirds compared to the aflibercept control, with 73% of DURAVYU-treated eyes remaining supplement-free up to 24 weeks.

The safety profile of DURAVYU was favorable, with no reported ocular or systemic serious adverse events linked to the treatment. These results underscore DURAVYU's potential as a best-in-class treatment option for DME patients, providing both visual and anatomical improvements.

Dr. Jay S. Duker, President and CEO of EyePoint, emphasized the significance of these findings, noting the potential of DURAVYU to revolutionize DME treatment with its superior dosing interval and safety. The trial outcomes suggest that DURAVYU can offer a durable treatment option, crucial for patients who currently face burdensome monthly injections that can lead to treatment discontinuation and further vision loss.

With the positive outcome from the Phase 2 VERONA trial, EyePoint plans to initiate a Phase 3 non-inferiority pivotal program by the end of 2025. The company is also preparing for discussions with the FDA in the coming months to advance this program.

Dr. Ramiro Ribeiro, Chief Medical Officer at EyePoint, expressed confidence in the transition to Phase 3 trials, citing the promising early results from the VERONA trial as a strong foundation for further development. The company aims to provide an effective, safe, and sustainable treatment solution for DME, addressing a significant unmet need in the market.

The trial design of VERONA was robust, involving 27 patients previously treated with standard anti-VEGF therapy. These participants were randomized to receive either of the two DURAVYU doses or aflibercept as a control. Key secondary outcomes included safety assessments and changes in BCVA and CST, measured by optical coherence tomography (OCT).

The results from the VERONA trial will be shared during the February 2025 Angiogenesis, Exudation, and Degeneration meeting, with complete six-month data to be presented at a forthcoming medical conference. This could pave the way for DURAVYU to become a pivotal therapy in treating retinal diseases like DME.

EyePoint's commitment to developing DURAVYU as a sustained-delivery option for VEGF-mediated retinal diseases is supported by substantial safety and efficacy data. The company continues to explore further indications, with ongoing Phase 3 trials in wet age-related macular degeneration (wet AMD) and plans to expand its treatment options in the field of serious retinal conditions.

With the growing prevalence of diabetes and its complications, such as DME, the healthcare system faces significant challenges. Innovations like DURAVYU offer promising solutions to improve patient outcomes and reduce the overall burden of disease management. As the company moves towards the next phase of clinical trials, the potential for DURAVYU to transform the treatment landscape remains strong.