EyePoint Pharmaceuticals has announced positive interim 16-week data from its Phase 2 VERONA clinical trial, evaluating Duravyu, an investigational sustained delivery therapy for diabetic macular edema (DME). The trial (NCT06099184) assesses Duravyu, which delivers vorolanib, a selective tyrosine kinase inhibitor, using EyePoint's Durasert E technology.
The interim data indicate that Duravyu demonstrated early, sustained, and clinically meaningful improvements in best-corrected visual acuity (BCVA) and anatomical control compared to the aflibercept control arm. The therapy also exhibited a favorable safety and tolerability profile. The 2.7mg dose is also under evaluation in Phase 3 pivotal trials for wet age-related macular degeneration (AMD). Full topline results are expected in the first quarter of 2025.
Key Findings from the VERONA Trial
The Phase 2 VERONA trial included 27 patients who completed the week 16 visit. Key findings include:
- BCVA Improvement: Patients treated with Duravyu 2.7mg showed an 8.9-letter improvement in BCVA compared to a 3.2-letter improvement in the aflibercept control group from baseline.
- CST Improvement: Central subfield thickness (CST) improved by 68.1 microns in the Duravyu 2.7mg arm versus 30.5 microns in the aflibercept arm compared to baseline, as measured by optical coherence tomography (OCT).
- Early Onset: Visual and anatomical gains were observed at Week 4, indicating rapid bioavailability of Duravyu.
- Reduced Need for Supplementation: 82% of eyes in the Duravyu 2.7mg arm were supplement-free versus 50% in the aflibercept control arm at 16 weeks.
- Safety Profile: The therapy continued to demonstrate a positive safety and tolerability profile, with no Duravyu-related ocular or systemic serious adverse events, including endophthalmitis, retinal vasculitis, insert migration, or intraocular inflammation.
Expert Commentary
Jay S. Duker, MD, president and CEO of EyePoint, expressed enthusiasm about the results, stating, "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."
Charles Wykoff, MD, PhD, director of Research, Retina Consultants of Texas and Co-Chair of EyePoint’s Scientific Advisory Board, highlighted the unmet need for longer-acting DME treatments: "There remains a significant need for differentiated and longer-acting treatments, as the current standard of care involves frequent intravitreal injections that can be a burden and have been associated with under-treatment. The interim data from the Phase 2 VERONA trial suggests promising activity in patients with active DME versus aflibercept alone and a favorable safety profile."
Adam Gerstenblith, MD, a principal investigator in the VERONA clinical trial, emphasized the importance of reducing treatment burden: "As a clinician dedicated to advancing retinal care, I am encouraged by the interim clinical data demonstrating 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. It enrolled 27 patients with DME previously treated with anti-VEGF therapy, who were randomized 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. 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.
