EyePoint Reports Positive 6-Month Results for Phase 2 VERONA Trial of Duravyu in DME

EyePoint Pharmaceuticals has announced positive 6-month results from its ongoing Phase 2 VERONA clinical trial evaluating Duravyu (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME). Duravyu is an investigational sustained-release therapy that delivers vorolanib, a selective tyrosine kinase inhibitor (TKI), using EyePoint’s proprietary bioerodible Durasert E platform.

The trial successfully met its primary endpoint, demonstrating an extended time to first supplemental injection compared to aflibercept control for both Duravyu doses. Additionally, the study showed clinically meaningful improvements in vision and anatomical control, with no Duravyu-related ocular or systemic serious adverse events (SAEs).

Clinical Findings: Duravyu’s Impact on Visual and Anatomical Outcomes

The Phase 2 VERONA study included 27 patients randomized to receive either Duravyu (1.34 mg or 2.7 mg) or aflibercept control. The primary endpoint was time to first supplemental aflibercept injection within 24 weeks, while secondary endpoints included safety, changes in best corrected visual acuity (BCVA), central subfield thickness (CST), and diabetic retinopathy severity scale (DRSS) scores.

As of January 16, 2025, data cut-off, key findings include:

       • Duravyu 2.7 mg demonstrated sustained improvements in both BCVA and CST:

               • +7.1 letter BCVA gain at Week 24

               • 75.9-micron CST reduction, representing 74% greater retinal drying compared to aflibercept control

       • Visual and anatomical improvements were observed as early as Week 4, indicating the immediate bioavailability of Duravyu.

       • 73% of eyes in the Duravyu 2.7 mg group remained supplement-free up to Week 24, compared to 50% in the aflibercept control group, confirming that efficacy results were driven by Duravyu rather than additional injections.

       • Duravyu 2.7 mg reduced treatment burden by over two-thirds, offering an extended dosing interval while maintaining visual outcomes.

Duravyu’s Favorable Safety Profile

The safety and tolerability of Duravyu remained strong throughout the trial, with:

       • No Duravyu-related ocular or systemic SAEs reported

       • No cases of:

               • Impaired vision

               • Endophthalmitis

               • Retinal vasculitis (occlusive or non-occlusive)

               • Insert migration

               • Intraocular inflammation (IOI)

Expert Perspectives on Duravyu’s Potential in DME Treatment

Jay S. Duker, MD, President and CEO of EyePoint Pharmaceuticals, highlighted the significance of these results:

"We are extremely pleased to report these highly positive VERONA results that demonstrate 2.7 mg Duravyu immediately and meaningfully improves both visual acuity and anatomy in DME patients with a superior dosing interval and excellent safety. This underscores the potential of Duravyu to be a best-in-class treatment for patients."

Dr. Carl Regillo, MD, FACS, Chief of Retina Service at Wills Eye Hospital and Co-Chair of EyePoint’s Scientific Advisory Board, emphasized Duravyu’s zero-order kinetics release, which ensures consistent VEGF receptor blockade for at least six months.

"This feature will be important in the DME population, giving patients and physicians a durable treatment option. Based on these meaningful Phase 2 results, I believe Duravyu demonstrates the ability to fundamentally alter the treatment paradigm in DME, and if approved, has the potential for significant adoption among retina specialists."

Next Steps: Phase 3 Trial Planned for 2025

The strong efficacy and safety data from the VERONA trial support the initiation of a noninferiority Phase 3 clinical program for DME. EyePoint plans to meet with the FDA in Q2 2025 to discuss the trial’s launch, with pivotal wet AMD trials also on track for a 2026 readout.

Upcoming Data Presentations

       • 16-week interim data will be presented at the Angiogenesis, Exudation, and Degeneration 2025 conference in February.

       • Full 6-month data will be presented at an upcoming major medical meeting.

Conclusion

The VERONA Phase 2 trial highlights Duravyu’s potential to redefine DME treatment, offering extended durability, immediate bioavailability, and a strong safety profile. With Phase 3 trials on the horizon, Duravyu is positioned as a potential blockbuster therapy in the retinal disease space.