Earlier this year, EyePoint Pharmaceuticals’ drug-device combo Duravyu missed the mark in a nonproliferative diabetic retinopathy (NPDR) study, raising doubts about the product’s potential in several sought-after ophthalmology indications. But EyePoint appears to have reversed its fortunes thanks to positive new interim data on its lead asset in diabetic macular edema (DME).
In the midstage VERONA trial, Duravyu delivered “early, sustained and clinically meaningful" improvements in best-corrected visual acuity (BVCA) and anatomical control in DME patients versus aflibercept, the molecule behind Regeneron’s retinal blockbuster Eylea, EyePoint said Monday. The interim data offer a look at the drug's performance after patients received 16 weeks of treatment in the ongoing trial.
In a note to clients Monday, Mizuho Securities analyst Graig Suvannavejh, Ph.D., called the interim Duravyu readout “very promising” with regards to both efficacy and safety. Deeming Duravyu’s path forward in DME “very viable,” Suvannavejh said that Mizuho continues to consider the eye insert a potential “best-in-class product that can now potentially be applied in multiple retinal disease settings.”
EyePoint’s stock was up about 35% midday Monday. The stock previously fell off a cliff in early May after the company reported a Duravyu miss in its phase 2 NPDR study, though it’s gradually been recovering over the past six months.
Duravyu is an intravitreal, sustained release insert that delivers the tyrosine kinase inhibitor vorolanib, which EyePoint licensed from Equinox Science in early 2020. Duravyu is not approved in the U.S., though the insert's active ingredient, vorolanib, has been approved in China in tablet form to treat certain patients with renal cell carcinoma in combination with everolimus.
Peeling back the layers on the DME data, patients on Duravyu 2.7 mg saw a BVCA improvement of 8.9 letters versus 3.2 letters in the trial’s aflibercept arm. Patients on EyePoint’s drug also experienced a 68.1-micron improvement in central subfield thickness—a measurement of the thickness of the retina’s macular region—compared to 30.5 microns in the aflibercept cohort.
Visual and anatomical gains for patients on Duravyu were apparent at the trial’s four-week mark, with the positive trend continuing for those who have had their 24-week visit, EyePoint explained.
As it stands, DME patients largely rely on frequent intravitreal injections to help control their disease, which can “be a burden and have been associated with under-treatment,” Charles Wykoff, M.D., Ph.D., director of research at Retina Consultants of Texas and co-chair of EyePoint’s scientific advisory board, said in a statement.
EyePoint’s 27-patient VERONA trial compared Duravyu at two doses—1.3 mg and 2.7 mg—to aflibercept in DME patients previously treated with a standard-of-care anti-VEGF therapy.
“Overall, the data come as a surprise … with respect to the high quality of the DME data,” Suvannavejh said in Mizuho’s Monday note. “Notably, according to the company, positive trends have also been seen in patients completing 24 weeks of treatment, and as such, [EyePoint] now represents the only company developing a TKI-based, maintenance treatment for retinal diseases with positive Phase 2 DME data in hand.”
The interim data came earlier than expected, with EyePoint now setting a timeline to unveil full top-line results in the first quarter of 2025, once all participants complete the trial. The company is also testing Duravyu in phase 3 studies for wet age-related macular degeneration (wAMD).
The positive DME data provide a much-needed rebound for EyePoint and Duravyu specifically, which had its worth in retinal disease questioned in May when the drug-device combo failed to pass muster in a phase 2 NPDR study.
At the time, EyePoint reported that only 5% of patients in the study’s 3-mg treatment arm—and none in the 2-mg arm—achieved a two-step Diabetic Retinopathy Severity Scale improvement or greater, causing the drug to fall short of the trial’s prespecified primary endpoint.
Mizuho’s Suvannavejh called the trial outcome a “significant disappointment” for EyePoint. He noted at the time that he expected “questions to rise to the surface regarding Duravyu's potential utility" in DME and wAMD.