EyePoint announces positive six-month results for phase 2 VERONA clinical trial of DURAVYU™ for diabetic macular edema meeting primary and secondary endpoints

The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU-related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. DURAVYU 2.7mg demonstrated a +7.1 letter BCVA gain and 76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the best-in-class potential for DURAVYU in serious retinal diseases.

We are extremely pleased to report these highly positive VERONA results that demonstrate 2.7mg DURAVYU immediately and meaningfully improves both visual acuity and anatomy in DME patients with a superior dosing interval and excellent safety. This underscores the potential of DURAVYU to be a best-in-class treatment for patients. DME is the leading cause of vision loss in working age adults and the second largest market in retinal diseases after wet age-related macular degeneration (wet AMD). The data from the VERONA trial demonstrate that after a single DURAVYU 2.7mg treatment there was an early and maintained improvement in both BCVA and retinal thickening as measured by OCT throughout the six-month trial, demonstrating the differentiated profile of DURAVYU with immediate bioavailability and zero order kinetics drug delivery. Importantly, the favorable safety and tolerability profile of DURAVYU continued with no DURAVYU-related ocular or systemic serious adverse events. These compelling results support a noninferiority pivotal program in DME, and we plan to meet with the FDA in the second quarter for potential initiation of a Phase 3 clinical trial later in 2025. With ongoing pivotal trials in wet AMD on track to read-out in 2026 and positive efficacy and safety data across multiple Phase 2 clinical trials, DURAVYU is well-positioned to become a potential blockbuster franchise.

said Jay S. Duker, M.D., President and Chief Executive Officer of EyePoint.

Phase 2 VERONA results as of January 16, 2025 data cut-off include:

• Both DURAVYU doses (1.34 mg and 2.7mg) met the primary endpoint of extended time to first supplemental injection versus aflibercept control.
• DURAVYU 2.7mg demonstrated an early and sustained improvement in both best corrected visual acuity (BCVA) and central subfield thickness (CST) as measured by optical coherence tomography (OCT).
  • BCVA improved +7.1 letters compared to baseline.
  • CST improved 75.9 microns compared to baseline representing 74% more drying in DURAVYU eyes versus aflibercept control.
• Visual and anatomical gains were observed at Week 4 demonstrating the immediate bioavailability of DURAVYU.
• 73% of eyes in the DURAVYU 2.7mg arm were supplement-free versus 50% in the aflibercept control arm up to week 24 underscoring that the positive efficacy results were driven by treatment with DURAVYU and not supplemental injections.
• Over two-thirds reduction in treatment burden for 2.7mg dose.
• DURAVYU favorable safety profile continues:
  • No DURAVYU-related ocular or systemic serious adverse events reported
  • No cases of:
    • Impaired vision
    • Endophthalmitis
    • Retinal vasculitis (occlusive or non-occlusive)
    • Insert migration
    • Intraocular inflammation (IOI)

DME is a prevalent disease with a significant need for more durable treatments. The data from the Phase 2 VERONA trial demonstrated that within four weeks, eyes treated with DURAVYU had a significant benefit for patients with DME, both visually and anatomically. The magnitude of these results gives us confidence moving forward into a Phase 3 noninferiority program with a differentiated treatment for patients with DME who need effective, safe and durable treatment options. We would like to thank the patients, investigators and their staff for participating in the trial, and we look forward to working with regulatory agencies to discuss next steps as we work to advance this innovative therapy and improve the lives of patients suffering from serious retinal diseases.

said Ramiro Ribeiro, M.D., Ph.D., Chief Medical Officer.

The diabetes epidemic and the associated increase in patients with DME has resulted in a significant burden to patients and the healthcare system. The number of diabetic retinopathy patients is predicted to reach 16 million by 2050, and diabetes-related vision loss is expected to cost 500 million US dollars annually. The average patient with DME is working age and requires burdensome monthly injections that can result in missed visits and chronic undertreatment. This can lead to irreparable vision loss and potential blindness. I am very encouraged by the Phase 2 VERONA data demonstrating the ability to improve vision and anatomy while maintaining a favorable safety and tolerability profile. Additionally, DURAVYU features zero order kinetics release, so the VEGF receptors remain blocked for at least six months enabling the ability to extend dosing intervals while maintaining the patient’s vision. This feature will be important in the DME population, giving patients and physicians a durable treatment option. Based on these meaningful Phase 2 results, I believe DURAVYU demonstrates the ability to fundamentally alter the treatment paradigm in DME, and if approved, has the potential for significant adoption among retina specialists.

said Carl Regillo, M.D., FACS, Chief of Retina Service at Wills Eye Hospital and Co-Chair of EyePoint’s SAB.

VERONA is a randomized, controlled, single-masked, open label Phase 2 trial of DURAVYU in DME patients previously treated with a standard-of-care anti-VEGF therapy. The trial enrolled 27 patients assigned to one of two intravitreal doses of DURAVYU (1.34mg or 2.7mg) or aflibercept control. The primary efficacy endpoint of the VERONA trial is time to first supplemental aflibercept injection up to 24 weeks based on established supplement criteria. Key secondary endpoints include safety, mean change in best corrected visual acuity (BCVA), mean change in central subfield thickness (CST) as measured by optical coherence tomography (OCT) and change in diabetic retinopathy severity scale (DRSS) over time. More information about the trial is available at clinicaltrials.gov (identifier: NCT06099184).

The 16-week interim data will be presented at Angiogenesis, Exudation, and Degeneration 2025 in February and the full six-month data at an upcoming medical meeting.