Business
Ocular Therapeutix™ Reports Fourth Quarter and Full Year 2024 Results and Business Highlights
Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"Announces several updates to enhance and accelerate AXPAXLI registrational program in wet AMD, potentially supporting label flexibility of 6-12 months to showcase expected best-in-class durability FDA approves Amendment to SOL-1 Special Protocol Agreement (SPA) to include AXPAXLI re-dosing at Weeks 52 and 76 SOL-1 trial Week 36 primary endpoint data now expected in 1Q 2026 due to requirement for masking until Week 52 to allow for re-dosing Inclusion of re-dosing in SOL-1, along with exceptional retention seen to date in the study, paves way for reduction of SOL-R trial size to 555 subjects (previously 825), potentially accelerating registration timelines Additional updates provided on SOL-R non-inferiority margin and rescue criteria Cash balance of $392.1M as of December 31, 2024, expected to fund operations into 2028 and the Company currently does not intend to raise additional capital this year FDA feedback on clinical trial design for AXPAXLI in NPDR and DME expected in 1H 2025 Ocular to host a 4Q 2024 conference call and webcast today, March 3rd, at 8:00 AM ET BEDFORD, Mass., March 03, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a biopharmaceutical company committed to redefining the retina experience, today reported financial results for the fourth quarter and year ended December 31, 2024 and provided recent business highlights, including updates to the registrational program for AXPAXLI™ (axitinib intravitreal hydrogel) in wet age-related macular degeneration (wet AMD) designed to accelerate a potential path to NDA submission and increased label flexibility. “2024 was a transformative year for Ocular Therapeutix. We sharpened our focus on a single, bold mission – to redefine the retina experience – starting with wet AMD as our top priority. Despite effective treatments today, the burden of frequent pulsatile dosing leads to high dropout rates and poor long-term visual outcomes. AXPAXLI has the potential to disrupt this paradigm by offering a more sustainable solution and possibly improve long-term outcomes. And we see wet AMD as just the beginning. There is a significant opportunity to expand into non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME), along with several other retinal diseases, where millions remain untreated,” said Pravin U. Dugel, MD, Executive Chai...