OCUL: SOL-1 Faz 3, AXPAXLI'nin yaşa bağlı makula dejenerasyonu (ıslak AMD) için en üst düzey verileri Şubat 2026'da bekleniyor

The company announced that 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.

Temel olgular

Bildirildi: 5 Şub 2026 12:13
Olay: Ön sonuçlar
Yön: Nötr
Şirket: OCULOcular Therapeutix
Varlık: axitinib
Kaynak: SEC 8-K
Güvenilirlik: Kaynaklı
tutma oranı: >%95
randomize denekler: 555
kurtarma kriteri karşılandı: >%95

Kaynak alıntısı

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

SEC 8-K