EyePoint Pharmaceuticals announces positive interim 16-Week data for ongoing Phase 2 VERONA clinical trial of Duravyu for DME

(Image credit: Adobe Stock/Paul)

EyePoint Pharmaceuticals Inc announced positive interim 16-week data for the ongoing Phase 2 VERONA clinical trial (NCT06099184) evaluating an investigational sustained delivery therapy (Duravyu) delivering patent-protected vorolanib, a selective tyrosine kinase inhibitor formulated in proprietary bioerodible Durasert E, for patients with diabetic macular edema (DME).

According to the company, the therapy demonstrated an early, sustained, and clinically meaningful improvement in best-corrected visual acuity (BCVA) and anatomical control versus the aflibercept control arm. A favorable safety and tolerability profile continued for both Duravyu arms. The 2.7mg dose is also being evaluated in the Phase 3 pivotal trials for wet AMD. The company said it expects to report the full topline results in the first quarter of 2025, once all patients complete the trial.¹

Jay S. Duker, MD, president and CEO of EyePoint, said the company is encouraged and excited by the positive interim results demonstrating clinically meaningful functional and concomitant structural improvement with a continued favorable safety profile of the therapy.

“DME is a prevalent disease with a significant need for more durable treatments,” he said. “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.”

Duker noted one of the most notable aspects of these data is that both doses showed an immediate benefit over aflibercept control in both BCVA and CST.

“We believe these compelling interim results support DURAVYU’s potential to advance to non-inferiority pivotal trials in DME,” he added. “With pivotal wet AMD clinical trials underway and promising DME interim data, DURAVYU has the potential to be the first sustained release therapy to market in two significant indications.”

Phase 2 VERONA interim 16-week results

• All patients (n=27) have completed the week 16 visit.
• DURAVYU 2.7mg demonstrated an early and sustained improvement in both BCVA and CST (central subfield thickness) as measured by optical coherence tomography (OCT).
• BCVA improved +8.9 letters versus +3.2 letters for aflibercept control compared to baseline.
• CST improved 68.1 microns versus 30.5 microns for aflibercept control compared to baseline.
• Visual and anatomical gains were observed at Week 4 demonstrating the immediate bioavailability of DURAVYU.
• Positive trend in BCVA and anatomy continued for patients that have reached the Week 24 visit.
• Continued positive safety and tolerability profile with no DURAVYU-related ocular or systemic serious adverse events. Additionally, there were no cases of:
• Endophthalmitis
• Retinal vasculitis (occlusive or non-occlusive)
• Insert migration to the anterior chamber
• Intraocular inflammation (IOI)
• 82% of eyes in the DURAVYU 2.7mg arm were supplement-free versus 50% in the aflibercept control arm at 16 weeks.

Charles Wykoff, MD, PhD, director of Research, Retina Consultants of Texas and Co-Chair of EyePoint’s Scientific Advisory Board, pointed out that DME is a sight-threatening complication of diabetes that can lead to severe visual loss and eventual blindness.

“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,” Wykoff said. “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. These results support the potential for Duravyu to bring substantial value to patients through stable, durable disease control.”

Adam Gerstenblith, MD, a principal investigator in the VERONA clinical trial and vitreoretinal surgeon at Mid Atlantic Retina Specialists, pointed out that reducing the treatment burden in patients with DME is a critical unmet need.

“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,” he said. The VERONA trial is an important step in the pursuit of treatment options for patients that are safe and durable, and I am pleased to be participating in research that has the potential to shift the treatment paradigm in DME and ultimately improve patient outcomes.”

The VERONA trial is a randomized, controlled, single-masked, open-label, phase 2 study investigating Duravyu for diabetic macular edema (DME) in patients previously treated with standard-of-care anti-VEGF therapy. The trial enrolled 27 patients, who were randomly assigned to receive 1 of 2 intravitreal doses of the therapy (1.3 mg or 2.7 mg) or a control treatment of aflibercept.¹

The company reports that the primary efficacy endpoint of the VERONA trial is the time to first supplemental aflibercept injection within 24 weeks, based on pre-specified criteria for supplementation. Key secondary endpoints include assessments of safety, mean change in best-corrected visual acuity (BCVA), mean change in central subfield thickness (CST) as measured by optical coherence tomography (OCT), and changes in diabetic retinopathy severity scale (DRSS) over time.¹

Reference:

1. EyePoint Pharmaceuticals Announces Positive Interim 16-Week Data for Ongoing Phase 2 VERONA Clinical Trial of DURAVYUTM for Diabetic Macular Edema | EyePoint Pharmaceuticals. EyePoint Pharmaceuticals. Published 2024. Accessed October 28, 2024.