EyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema

EyePoint Pharmaceuticals查看公司主页 has announced positive interim results from its Phase 2 VERONA clinical trial, evaluating Duravyu查看药品详情, an investigational sustained-release therapy for diabetic macular edema (搜索)搜索该疾病 (DME (搜索)搜索该疾病). The trial (NCT06099184查看临床试验) assesses Duravyu, which delivers the tyrosine kinase inhibitor vorolanib查看药品详情 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查看药品详情 control arm. Both Duravyu查看药品详情 arms demonstrated a favorable safety and tolerability profile. The 2.7mg dose is also under evaluation in Phase 3 pivotal trials for wet AMD (搜索)搜索该疾病. 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查看药品详情 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查看药品详情 2.7mg arm versus +3.2 letters in the aflibercept查看药品详情 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查看药品详情-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查看药品详情 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 (搜索)搜索该疾病, highlighting Duravyu查看药品详情'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 (搜索)搜索该疾病, 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查看药品详情'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 (搜索)搜索该疾病 patients. He is encouraged by the potential for Duravyu查看药品详情 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查看药品详情 for DME (搜索)搜索该疾病 in patients previously treated with standard-of-care anti-VEGF (搜索)搜索该靶点 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查看药品详情. 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.