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Ocular Therapeutix™ Announces First Patients Enrolled in Phase 3 SOL-R Wet AMD Study
SOL-R evaluates repeat AXPAXLI™ dosing for wet age-related macular degeneration (wet AMD) Global non-inferiority study comparing AXPAXLI, dosed every six
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"SOL-R evaluates repeat AXPAXLI™ dosing for wet age-related macular degeneration (wet AMD) Global non-inferiority study comparing AXPAXLI, dosed every six months, to 2 mg aflibercept every eight weeks BEDFORD, Mass., July 30, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that the first patients have been enrolled in the Phase 3 SOL-R clinical trial evaluating repeat dosing of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD). SOL-R is a global, 825-patient, non-inferiority study evaluating repeat dosing of AXPAXLI every six months (Q6M) compared to 2 mg aflibercept, dosed every eight weeks (Q8W) in patients with wet AMD. A third arm evaluating 8 mg aflibercept dosed Q6M is incorporated to ensure the study is adequately masked. The trial is evaluating AXPAXLI versus the current standard of care under the “real world” requirements of a repeat-dosing regimen. “Our first Phase 3 trial, SOL-1, is intended to show that AXPAXLI can safely and durably maintain visual acuity in patients with wet AMD. SOL-R is intended to build on that by providing physicians with important evidence regarding the potential to re-dose AXPAXLI every six months, which better aligns with a likely ‘real world’ experience,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “SOL-R will initially enroll patients who do not qualify to be randomized in SOL-1. Subsequently, SOL-R will be opened to direct enrollment of patients who are treatment naïve or diagnosed with wet AMD within three months prior to enrollment. Patients enrolled in SOL-R are similar to those enrolled in our successful U.S. Phase 1 study, with further enrichment through multiple aflibercept loading doses. Further, these patients are evaluated to limit retinal fluid fluctuations between visits prior to randomization, increasing our confidence in the study’s potential success.” “There is increasing evidence that pulsatile VEGF suppression may result in OCT fluctuations that could lead to poor long t...