原始出處紀錄
決策級主要結果 (Topline)
OCUL：AXPAXLI 用於濕性 AMD 的 SOL-1 第三期初步數據預計於 2026 年 2 月公布
該公司宣布，AXPAXLI 用於濕性 AMD 的 SOL-1 第三期優效性試驗結果將於第 49 屆 Macula Society 年會（2026 年 2 月 25-28 日）上發表。若結果正面，Ocular 計畫依據單一 SOL-1 52 週數據集，透過 505(b)(2) 途徑提交 NDA。
關鍵事實
來源摘錄
EX-99.1 2 tm265061d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights SOL-1 Phase 3 superiority trial results remain masked to date SOL-1 data expected to be presented at the 49 th Macula Society Annual Meeting Ocular plans to submit NDA for AXPAXLI™ in wet AMD based on SOL-1 52 Week data, pending positive results and planned FDA interactions Completed randomization of 631 subjects in SOL-R Phase 3 non-inferiority trial in December 2025; timing of topline results accelerated and now anticipated in 1Q 2027 HELIOS-3 Phase 3 trial in diabetic retinopathy underway Cash balance of $737.1 million as of December 31, 2025, with expected runway into 2028 BEDFORD, MA, February 05, 2026 (GLOBE NEWSWIR
此資產的更多資訊
重大
2026年6月17日
下午12:45
OCULOcular Therapeutix