Betta Pharmaceuticals Co.,Ltd. (300558.SZ) has disclosed that its partner, EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), released data from the LUGANO study, the first of two pivotal Phase III clinical trials evaluating the investigational vorolanib ophthalmic insert DURAVYU™ for the treatment of wet age-related macular degeneration (wAMD). Based on the complete dataset, the study did not achieve its pre-specified primary endpoint, as DURAVYU failed to demonstrate non-inferiority versus aflibercept.

Two key factors contributed to this outcome. First, the DURAVYU treatment arm had an asymmetric case cohort: 9 of 211 subjects (approximately 4%) experienced a vision loss of 15 or more letters unrelated to the wAMD disease itself, whereas no such cases were observed in the aflibercept control group. Second, the aflibercept control group in this trial performed significantly better than expected compared with historical Phase III studies, where roughly 3% to 5% of subjects receiving aflibercept typically experience a 15-letter or greater vision decline. A post-hoc interim analysis, excluding the asymmetric 4% cohort, showed that DURAVYU could meet the non-inferiority criterion relative to aflibercept (nominal p-value = 0.0096); however, this exploratory analysis was not a pre-specified trial endpoint.

Topline data from LUCIA, the second pivotal Phase III study of DURAVYU in wAMD, are expected in the fourth quarter of 2026. EyePoint plans to combine these results and potentially submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DURAVYU in the wAMD indication in the first half of 2027, contingent on the LUCIA outcomes. Additionally, the COMO and CAPRI Phase III trials evaluating DURAVYU for diabetic macular edema (DME) have completed enrollment, with topline data anticipated in the fourth quarter of 2027.

Given that the LUGANO pivotal Phase III trial did not meet its pre-specified primary endpoint, the project's subsequent clinical advancement, regulatory filing, and commercialization efforts face uncertainty. The potential impacts on the company are as follows: as of the announcement date, Betta Pharmaceuticals Co.,Ltd. has received total upfront and milestone payments of $6 million from EyePoint for the licensed local delivery development of vorolanib in ophthalmic indications, and these payments are non-refundable under the agreement. The realization of future development milestones and sales royalties remains uncertain, with revenue recognition timing and amounts to be determined based on actual progress and contractual terms. The product is still in clinical trials and has not been commercialized, contributing no revenue to current operations. This clinical outcome will not materially affect the company's ongoing production and business activities.