Earlier this year, EyePoint Pharmaceuticals faced setbacks when their drug-device combination, Duravyu, did not perform well in a study for nonproliferative diabetic retinopathy (NPDR). This raised concerns about its potential in other eye-related conditions. However, recent developments have improved the situation for EyePoint. New interim data from a study on diabetic macular edema (DME) showed that Duravyu significantly improved vision and eye anatomy in patients compared to a popular treatment called aflibercept, known as Eylea.
In the ongoing VERONA trial, after 16 weeks of treatment, patients using Duravyu showed better vision improvement and eye health than those using aflibercept. An analyst from Mizuho Securities described the data as “very promising” in terms of both effectiveness and safety. This suggests that Duravyu could become a leading treatment option for various retinal diseases.
EyePoint’s stock rose by about 35% following this news. Previously, the stock had dropped significantly after disappointing results in an NPDR study in May but has been gradually recovering since then. Duravyu is currently not approved in the U.S., but its active ingredient, vorolanib, is approved in China for treating kidney cancer in pill form.
The VERONA trial involved 27 patients, comparing two doses of Duravyu to aflibercept in DME patients who had already received standard anti-VEGF therapy. Results showed notable improvement in vision and retinal thickness in patients using Duravyu, with benefits appearing as early as four weeks into treatment.
Currently, DME patients often need frequent eye injections, which can be burdensome and lead to under-treatment. Duravyu, as a sustained-release insert, could offer a less frequent alternative.
Mizuho Securities emphasized the high quality of the DME data and pointed out that EyePoint is the only company developing a treatment based on tyrosine kinase inhibitors (TKIs) for retinal diseases with positive Phase 2 results. EyePoint plans to release full trial results in early 2025 and is also testing Duravyu for wet age-related macular degeneration (wAMD).
These positive findings are crucial for EyePoint after the previous setback in the NPDR study, where Duravyu did not meet key outcomes. An analyst noted that the initial NPDR results were disappointing but the promising DME data now offer a potential path forward for the company.