EyePoint Pharmaceuticals releases an encouraging safety update for EYP-1901 under PAVIA and DAVIO 2 Phase 2 Clinical Studies

EyePoint Pharmaceuticals, Inc., a firm devoted to creating and marketing treatments aimed at enhancing the quality of life for people suffering from severe ocular conditions, has released promising preliminary safety data for its leading product candidate EYP-1901. This data was obtained from the company's current Phase 2 PAVIA trial that is investigating EYP-1901's potential as a nine-month intervention for moderate to severe non-proliferative diabetic retinopathy. Each treatment group in the PAVIA study has completed a minimum of 3 months' follow-up after dosing as of September 1, 2023.

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Approximately 170 patients have been administered EYP-1901 with at least three months of post-injection monitoring in the continuing Phase 2 PAVIA and DAVIO 2 clinical studies as well as the concluded DAVIO 1 trial with no reported drug-associated ocular SAEs or systemic SAEs.

"We are encouraged by the favourable concealed safety effects that have been observed in EYP-1901 so far in the 17 patients treated in the Phase 1 DAVIO trial for wet AMD and roughly 150 more patients in our two Phase 2 studies: DAVIO 2 and PAVIA. The results fortify our optimism about EYP-1901 emerging as a potential game-changer for those patients who would benefit from a safe, sustained therapeutic option for VEGF-mediated diseases," declared Jay S. Duker, M.D., the President and CEO of EyePoint Pharmaceuticals.

"In the Phase 2 PAVIA trial involving 77 patients, the research team reports no drug-related ocular SAEs or systemic SAEs, thus demonstrating EYP-1901's outstanding safety record in NPDR for the first time. Our enthusiasm remains high for the possibilities of EYP-1901 in NPDR, a lasting illness wherein over 90% of patients currently receive no therapeutic intervention besides monitoring by their eye care specialist until vision-endangering complications emerge. We are on schedule to release our preliminary findings from the DAVIO 2 trial in December this year and from the PAVIA trial in Q2 of 2024." Jay S. Duker remarked.

EYP-1901 is under development as a sustained delivery treatment for retinal disease, combining a bioerodible formulation of EyePoint's exclusive Durasert® delivery technology (Durasert E™) with vorolanib, a tyrosine kinase inhibitor. Encouraging safety and effectiveness findings from the Phase 1 DAVIO clinical trial of EYP-1901 in wet AMD revealed a favourable safety record along with consistent visual acuity and OCT.

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According to the data provided by the Synapse Database, As of September 14, 2023, there are 36 investigational drugs for the PDGFR and VEGFR target, including 96 applicable indications,69 R&D institutions involved, with related clinical trials reaching 1755，and as many as 6102 patents.

Vorolanib is a small molecule drug with potential applications in various therapeutic areas. Its approval for multiple indications, including renal cell carcinoma and diabetic retinopathy, highlights its versatility and potential to address different medical conditions. The drug's approval in China indicates its availability for patients in the country, while its global approval suggests its potential for international use. As a result, Vorolanib represents an important development in the field of biomedicine, offering new treatment options for patients with diverse medical needs.