EyePoint Pharma Reports Positive 16-Week Data in Phase 2 DURAVYU™ Trial for Diabetic Macular Edema

EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), dedicated to developing novel treatments for serious retinal diseases, shared positive interim 16-week data from the Phase 2 VERONA clinical trial of DURAVYU, a sustained release therapy delivering vorolanib, a selective tyrosine kinase inhibitor in Durasert E™, for diabetic macular edema (DME). The current results indicate that DURAVYU 2.7mg produces early and sustained improvements in best-corrected visual acuity (BCVA) and anatomical measures compared with the aflibercept control group, while maintaining a favorable safety profile. The Company expects to announce full topline results in the first quarter of 2025.

“We are thrilled by these promising results showing significant functional and structural improvements with DURAVYU, coupled with continued safety,” said Jay S. Duker, M.D., President and CEO of EyePoint. "DME is widespread and requires more enduring treatments. The interim findings of the VERONA trial indicate that a single DURAVYU 2.7mg treatment leads to significant early and sustained BCVA improvements and notable anatomical gains, suggesting its substantial potential in DME. Both DURAVYU doses provided immediate benefits over aflibercept in BCVA and CST. These compelling results support the advancement of DURAVYU to pivotal trials. With ongoing pivotal trials for wet AMD and promising DME data, DURAVYU could become the first sustained release therapy for two major conditions."

All 27 patients completed their week 16 visit. DURAVYU 2.7mg showcased early and sustained BCVA and CST improvements, measured by optical coherence tomography (OCT). BCVA gains were +8.9 letters compared to +3.2 letters for aflibercept control. CST saw a reduction of 68.1 microns versus 30.5 microns for aflibercept control. Visual and anatomical benefits were noted at Week 4, demonstrating DURAVYU’s immediate bioavailability. Positive trends continued for those reaching the Week 24 visit, with no DURAVYU-related serious ocular or systemic adverse events. Furthermore, 82% of eyes in the DURAVYU 2.7mg group required no supplemental treatment at 16 weeks, compared to 50% in the aflibercept control group.

Charles Wykoff, M.D., Ph.D., Director of Research, Retina Consultants of Texas and Co-Chair of EyePoint’s Scientific Advisory Board, emphasized the need for long-acting treatments for DME due to the burdensome nature of frequent injections. He noted the promising activity and favorable safety profile of DURAVYU observed in the interim data. Adam Gerstenblith, M.D., a vitreoretinal surgeon and principal investigator in the VERONA trial, highlighted the importance of reducing treatment burdens while maintaining or improving vision and anatomy, calling the VERONA trial a significant step towards better treatment options.

The VERONA trial is a randomized, controlled, single-masked Phase 2 study involving patients with DME previously treated with anti-VEGF therapy. It enrolled 27 patients assigned to either DURAVYU doses (1.3mg or 2.7mg) or aflibercept control. The primary endpoint is time to first supplemental aflibercept injection up to 24 weeks. Secondary endpoints include safety, BCVA changes, CST changes, and diabetic retinopathy severity scale changes over time. 

DME leads to vision loss in people with diabetes due to leaking blood vessels causing retinal swelling. The global prevalence of DME is increasing with rising diabetes cases. Current treatments include frequent intravitreal injections, which are burdensome for patients and healthcare providers. DURAVYU aims to offer a more durable solution, reducing treatment frequency while maintaining efficacy.

EyePoint’s pipeline leverages its Durasert E™ technology for sustained intraocular drug delivery. DURAVYU is under investigation for both wet AMD and DME, with Phase 3 and 2 clinical trials respectively, and full topline data from the DME trial expected in Q1 2025. Future directions include further pivotal trials and potential market approval.

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