EyePoint Pharmaceuticals has announced positive interim results from its Phase 2 VERONA clinical trial, evaluating Duravyu, an investigational sustained-release therapy for diabetic macular edema (DME). The trial (NCT06099184) assesses Duravyu, which delivers the tyrosine kinase inhibitor vorolanib via the Durasert E platform.
The 16-week interim data indicated early, sustained, and clinically meaningful improvements in best-corrected visual acuity (BCVA) and anatomical control compared to the aflibercept control arm. Both Duravyu arms demonstrated a favorable safety and tolerability profile. The 2.7mg dose is also under evaluation in Phase 3 pivotal trials for wet AMD. Topline results are expected in the first quarter of 2025.
Key Findings from the VERONA Trial
The Phase 2 VERONA trial's interim results at 16 weeks revealed that all 27 patients had completed their week 16 visit. The Duravyu 2.7mg arm demonstrated an early and sustained improvement in both BCVA and central subfield thickness (CST), as measured by optical coherence tomography (OCT).
Specifically, BCVA improved by +8.9 letters in the Duravyu 2.7mg arm versus +3.2 letters in the aflibercept control arm compared to baseline. CST improved by 68.1 microns in the Duravyu arm versus 30.5 microns in the aflibercept arm. Visual and anatomical gains were observed as early as Week 4, demonstrating the immediate bioavailability of Duravyu. This positive trend in BCVA and anatomy continued for patients who reached the Week 24 visit.
The therapy also maintained a positive safety and tolerability profile, with no Duravyu-related ocular or systemic serious adverse events reported. There were no cases of endophthalmitis, retinal vasculitis, insert migration to the anterior chamber, or intraocular inflammation (IOI). Furthermore, 82% of eyes in the Duravyu 2.7mg arm were supplement-free versus 50% in the aflibercept control arm at 16 weeks.
Expert Commentary
Jay S. Duker, MD, president and CEO of EyePoint, expressed enthusiasm about the results, noting the clinically meaningful functional and structural improvements with a continued favorable safety profile. He emphasized the significant need for more durable treatments for DME, highlighting Duravyu's potential as a sustained delivery therapy.
Charles Wykoff, MD, PhD, director of Research at Retina Consultants of Texas and Co-Chair of EyePoint’s Scientific Advisory Board, noted the importance of longer-acting treatments for DME, given the burden and potential for under-treatment associated with frequent intravitreal injections. He stated that the VERONA trial data suggests promising activity and a favorable safety profile, supporting Duravyu's potential to provide stable, durable disease control.
Adam Gerstenblith, MD, a principal investigator in the VERONA trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists, highlighted the critical unmet need to reduce the treatment burden for DME patients. He is encouraged by the potential for Duravyu 2.7mg to extend treatment intervals while improving vision without sacrificing anatomy.
Trial Design
The VERONA trial is a randomized, controlled, single-masked, open-label, phase 2 study investigating Duravyu for DME in patients previously treated with standard-of-care anti-VEGF therapy. The trial enrolled 27 patients, randomly assigned to receive one of two intravitreal doses of Duravyu (1.3 mg or 2.7 mg) or aflibercept. The primary efficacy endpoint is the time to first supplemental aflibercept injection within 24 weeks, based on pre-specified criteria. Key secondary endpoints include assessments of safety, mean change in BCVA, mean change in CST, and changes in diabetic retinopathy severity scale (DRSS) over time.
