Zhitong Financial App News, Beida Pharmaceutical (300558.SZ) announced that its partner EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT, hereinafter “EyePoint”) announced the first of two key phase III clinical trials of the research voronibu ophthalmic preparation EYP-1901 intravitreal implant (DURAVYU™, hereinafter referred to as “DURAVYU”) to treat wet age-related macular degeneration (hereinafter referred to as “WamD”) LUGANO's data.
Based on the complete test data set, this study did not achieve a pre-set primary endpoint, and DURAVYU did not achieve non-inferior efficacy compared to abacip. There are two key factors in this result: one is that the DURAVYU trial group had an asymmetric case cohort. Of the 211 subjects, 9 cases (about 4%) had vision loss of at least 15 letters unrelated to wAMd disease itself, while there were no similar cases in the abibasip control group; second, the efficacy of the abibasip control group in this trial was significantly superior to those expected in historical phase III trials. In historical similar studies, about 3% ~ 5% of subjects treated with abibasip experienced vision loss of at least 15 letters.
After excluding 4% of the subjects in the asymmetric cohort described above after post-mortem analysis, DURAVYU was able to meet the non-inferior standard (nominal p-value = 0.0096) compared to abacip. This analysis was an exploratory post-mortem analysis, and did not pre-set an end point for the test.
Headline data for Lucia, the second key phase III clinical trial of Duravyu in the two key phase III clinical trials of treating WAMD, is expected to be released in the fourth quarter of 2026. EyePoint plans to combine the results of this study or submit Duravyu's New Drug Marketing Application (NDA) for WAMD indications to the US Food and Drug Administration (FDA) in the first half of 2027. The details of the application will depend on the data results of the LUCIA study. Furthermore, DURAVYU's COMO and CAPRI phase III clinical trials for diabetic macular edema (DME) have now all been enrolled. The top-line data for these two trials is expected to be announced in the fourth quarter of 2027.
Since DURAVYU's complete data set of LUGANO critical phase III clinical trials did not reach the primary target, there are uncertainties about the subsequent clinical promotion, registration and commercialization process of the project, and the possible impact on the company is as follows: As of the date of this announcement, the company has received a total of 6 million US dollars in down payments and milestone payments to authorize EyePoint to develop voronib ophthalmic indications by means of topical administration. According to the licensing agreement, these payments are not refundable. There is uncertainty about the product's subsequent development milestones and the achievement of sales commission payments, and the company will confirm the timing and amount of relevant revenue based on actual progress and agreement agreements. The product is currently in clinical trials, has not been commercially sold, and has not contributed to the company's current revenue. The current clinical results will not have a significant impact on the company's current production and operation activities.