EyePoint Announces Positive 6-Month Results for the Phase 2 VERONA Clinical Trial of Duravyu for DME

EyePoint Pharmaceuticals announced positive 6-month results for the ongoing phase 2 VERONA clinical trial evaluating Duravyu (vorolanib intravitreal insert) for diabetic macular edema (DME). Duravyu is an investigational sustained delivery therapy delivering vorolanib, a selective tyrosine kinase inhibitor (TKI) formulated in proprietary bioerodible Durasert E.

The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both Duravyu doses, the company announced in a news release. 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. 

“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,” Jay S. Duker, MD, President and Chief Executive Officer of EyePoint, said in a company news release. “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 (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 6-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," Dr. Duker added. 

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 BCVA and 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)

"Duravyu features zero order kinetics release, so the VEGF receptors remain blocked for at least 6 months enabling the ability to extend dosing intervals while maintaining the patient’s vision," said Carl Regillo, M.D., FACS, Chief of Retina Service at Wills Eye Hospital and Co-Chair of EyePoint’s SAB. "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.”

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 6-month data at an upcoming medical meeting.