DURAVYU Hits Primary Phase 2 Endpoint, Reduces Treatment Burden in DME

Carl Regillo, MD

Credit: Wills Eye Hospital

Positive 6-month data from the Phase 2 VERONA clinical trial evaluating vorolanib intravitreal insert (DURAVYU) reported a meaningful improvement in vision and anatomy in diabetic macular edema (DME), meeting the trial’s primary and secondary endpoints.¹

Announced by EyePoint Pharmaceuticals on February 5, 2025, both doses of DURAVYU (1.34 mg and 2.7 mg) achieved an extended time to the first supplemental anti-vascular endothelial growth factor (VEGF) injection, compared with the aflibercept control cohort.

“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,” said Carl Regillo, MD, chief of retina service at Wills Eye Hospital, in a statement. “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.”

DURAVYU, formerly known as EYP-1901, is an investigational sustained therapy delivering vorolanib, a selective tyrosine kinase inhibitor (TKI), formulated in EyePoint’s proprietary bioerodible Durasert E. It is developed as a maintenance treatment for patients with chronic VEGF-mediated retinal diseases, offering a new mechanism as a potent and highly selective pan-VEGF receptor inhibitor.¹

The vorolanib intravitreal insert has previously achieved strong safety and efficacy results in people with neovascular (wet) age-related macular degeneration (nAMD). In the Phase 2 DAVIO 2 trial, DURAVYU achieved a treatment burden reduction of ~88% 6 months after treatment, with ≥80% of patients with nAMD remaining supplement-free or receiving 1 supplemental anti-VEGF injection.²

The randomized, controlled, single-masked, open-label Phase 2 VERONA trial evaluated DURAVYU in patients with DME previously treated with anti-VEGF therapy. A total of 27 patients were assigned to intravitreal DURAVYU 1.34 mg or 2.7 mg or aflibercept control. Based on established supplement criteria, the primary efficacy endpoint was the time to first supplemental aflibercept injection at 24 weeks.¹

Analysis of VERONA showed both doses of DURAVYU achieved an extended time to the first supplement injection, meeting the primary endpoint. Key secondary endpoints, including the mean change in best-corrected visual acuity (BCVA) and central subfield thickness (CST), were additionally positive in the DURAVYU arms.

DURAVYU 2.7 mg exhibited an early and sustained visual and anatomic benefit, improving +7.1 letters and +75.9 µm, respectively, compared with baseline. This anatomic benefit represented 74% more drying in DURAVYU eyes versus the aflibercept control. EyePoint indicated gains were observed at Week 4, suggesting the immediate bioavailability of the insert.

Approximately three-quarters (73%) of eyes in the DURAVYU 2.7mg arm remained supplement-free, compared with half (50%) of eyes in the aflibercept control arm, up to Week 24. Overall, this represented a two-thirds reduction in the treatment burden of the 2.7 mg arm. Safety of DURAVYU remained favorable, with no reports of treatment-related ocular or systemic serious adverse events or cases of endophthalmitis, retinal vasculitis, or intraocular inflammation.

“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,” Regillo added.¹

In the release, EyePoint indicated these Phase 2 data support the DME program’s advancement to Phase 3, with plans to initiate at the end of 2025. The company also announced the 16-week VERONA interim data will be published at Angiogenesis, Exudation, and Degeneration 2025, with full 6-month data expected at an upcoming medical meeting.¹

“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,” said Jay S. Duker, MD, president and chief executive officer of Eyepoint, in a statement.¹ “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.”

References

1. _{EyePoint announces positive six-month results for the phase 2 verona clinical trial of DURAVYUTM for Diabetic macular edema meeting primary and secondary endpoints. EyePoint Pharmaceuticals. February 5, 2025. Accessed February 5, 2025. https://investors.eyepointpharma.com/news-releases/news-release-details/eyepoint-announces-positive-six-month-results-phase-2-verona.}
2. _{Iapoce C. EYP-1901 for wet AMD achieves primary endpoint in davio 2 trial. HCP Live. December 7, 2023. Accessed February 5, 2025. https://www.hcplive.com/view/eyp-1901-wet-amd-achieves-primary-endpoint-davio-2-trial.}