By Fineline Cube Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that its partner EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT) disclosed data from LUGANO, the first of two pivotal Phase III clinical trials evaluating EYP‑1901 (vorolanib ophthalmic insert, brand name: DURAVYU), an investigational intravitreal insert for the treatment of wet age‑related macular degeneration (wAMD). The study did not achieve its pre‑specified primary endpoint.
Trial Outcome Summary
| Item | Detail |
|---|---|
| Trial Name | LUGANO (first of two pivotal Phase III trials) |
| Product | EYP‑1901 / DURAVYU (vorolanib ophthalmic insert) |
| Indication | Wet age‑related macular degeneration (wAMD) |
| Route | Intravitreal insert |
| Comparator | Aflibercept 2 mg, administered per labeled indication |
| Result | Primary endpoint not met; non‑inferiority not demonstrated |
| Disclosure Date | 18 Aug 2026 |
Primary Endpoint Design
- Endpoint: Mean change in Best Corrected Visual Acuity (BCVA) from baseline
- Assessment Period: Pooled period from Day 1 to Weeks 52 and 56
- Non‑Inferiority Margin: ‑4.5 letters
- Objective: Demonstrate non‑inferiority of DURAVYU versus aflibercept 2 mg
- Outcome: Based on the complete trial dataset, DURAVYU failed to demonstrate non‑inferiority relative to aflibercept
Partnership Structure & Greater China Rights
| Item | Detail |
|---|---|
| Agreement Date | May 2022 |
| Parties | Betta Pharmaceuticals × EyePoint Pharmaceuticals |
| Betta’s Rights | Exclusive development and commercialization of EYP‑1901 in Greater China (Mainland China, Hong Kong, Macao, and Taiwan) |
| EyePoint’s Rights | Ophthalmic rights for EYP‑1901 in the rest of the world |
Market Impact & Outlook
- Second Pivotal Trial Pending: LUGANO is the first of two pivotal Phase III trials; results from the second study will be critical in determining the overall development fate of the EYP‑1901 program.
- Competitive Landscape: The wAMD market is dominated by anti‑VEGF injectables including aflibercept, ranibizumab and newer long‑acting agents; a sustained‑release insert would have differentiated on treatment burden reduction had efficacy held up.
- Greater China Exposure: The outcome directly affects Betta Pharmaceuticals’ exclusive regional program, raising questions about development timelines and commercial planning across Mainland China, Hong Kong, Macao, and Taiwan.
- Watch Items: EyePoint’s next steps on the second pivotal trial, potential protocol or dosing adjustments, and any regulatory engagement regarding the path forward.
Forward-Looking Statements
This brief contains forward‑looking statements regarding clinical development, regulatory outcomes, and commercial expectations for EYP‑1901 (DURAVYU). Actual results may differ due to risks including additional trial results, regulatory decisions, and competitive dynamics.-Fineline Info & Tech