प्राथमिक स्रोत रिकॉर्ड
निर्णायकटॉपलाइन परिणाम
OCUL: वेट AMD में AXPAXLI के लिए फेज़ 3 SOL-1 टॉपलाइन डेटा फरवरी 2026 में अपेक्षित
कंपनी ने घोषणा की कि SOL-1 Phase 3 superiority trial results for AXPAXLI in wet AMD will be presented at the 49th Macula Society Annual Meeting (Feb 25-28, 2026). Pending positive results, Ocular plans to submit an NDA based on the single SOL-1 52-week dataset under the 505(b)(2) pathway.
मुख्य तथ्य
स्रोत का अंश
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
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