EyePoint Pharma Announces Positive Interim Results for Duravyu in Phase 2 VERONA Trial for DME

EyePoint Pharmaceuticals reported interim 16-week data from its ongoing phase 2 VERONA clinical trial, which is assessing the investigational sustained delivery therapy Duravyu. The therapy, developed for patients with diabetic macular edema (DME), leverages a proprietary bioerodible Durasert E technology to deliver patent-protected vorolanib, a selective tyrosine kinase inhibitor, and is showing notable early results in visual and anatomical improvements.

The VERONA study interim results demonstrate that Duravyu 2.7mg provides an early, sustained, and meaningful improvement in best-corrected visual acuity (BCVA) and central subfield thickness (CST) when compared to the control treatment, aflibercept. Additionally, Duravyu maintains a favorable safety and tolerability profile. EyePoint anticipates reporting full topline data in Q1 2025.

“We are encouraged and excited by these highly positive interim results demonstrating clinically meaningful functional and concomitant structural improvement with a continued favorable safety profile of Duravyu,” Jay S. Duker, MD, President and CEO of EyePoint, said in a company news release. “DME is a prevalent disease with a significant need for more durable treatments. The interim data from the VERONA trial demonstrates that after a single Duravyu 2.7mg treatment, there was a meaningful, early and maintained improvement in BCVA paired with strong anatomical improvement in retinal thickness, demonstrating the potential for Duravyu in DME as a sustained delivery therapy. One of the most notable aspects of these data is that both Duravyu doses showed an immediate benefit over aflibercept control in both BCVA and CST.”

Key 16-Week Findings from the VERONA Trial:

• Visual Improvement: BCVA improved by +8.9 letters in the Duravyu 2.7mg group compared to +3.2 letters in the aflibercept control group
• Anatomical Improvement: CST decreased by 68.1 microns for Duravyu 2.7mg patients versus 30.5 microns in the aflibercept control group
• Durability and Supplement-Free Rates: 82% of eyes in the Duravyu 2.7mg group were supplement-free at 16 weeks, compared to 50% in the control group
• Safety: No serious adverse events, including endophthalmitis, retinal vasculitis, insert migration, or intraocular inflammation, were reported

The randomized, controlled, single-masked phase 2 VERONA trial enrolled 27 patients who had previously received standard anti-VEGF therapy for DME. Patients were assigned to one of two Duravyu doses (1.3mg or 2.7mg) or to the aflibercept control group. The primary endpoint is the time to first supplemental aflibercept injection over a 24-week period, with key secondary endpoints including safety and changes in BCVA, CST, and diabetic retinopathy severity scale.

Further details on the VERONA trial can be found at clinicaltrials.gov (identifier: NCT06099184).