Ocular Therapeutix Q2 2025: Unpacking Key Contradictions in SOL-R Trial Criteria and FDA Relations
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最新报道：Ocular Therapeutix has progressed in its SOL-1 and SOL-R trials, achieving strong patient retention with 344 participants randomized and completing a 6-month loading phase. The company strategically adjusted SOL-R's rescue criteria (requiring 5+ letter vision loss plus 75µm retinal thickening) for competitive advantage, not due to FDA requirements. FDA discussions revealed contradictions in trial criteria changes, while the firm's $390M cash reserves will support future studies, including potential expansion into NPDR/DME. Long-term extension studies are planned to validate 2-year safety data, aiming to bolster physician confidence and demonstrate real-world treatment benefits.
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