原始来源记录
决策级顶线结果
OCUL：AXPAXLI用于湿性AMD的SOL-1 III期顶线数据预计于2026年2月公布
该公司宣布，AXPAXLI用于湿性AMD的SOL-1 III期优效性试验结果将在第49届黄斑病学会年会（2026年2月25-28日）上公布。若结果积极，Ocular计划基于SOL-1 52周单一数据集，通过505(b)(2)途径提交NDA。
关键事实
来源摘录
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