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Oculis Announces First Patient First Visit in Phase 3 OPTIMIZE-2 Trial of OCS-01 for the Treatment of Inflammation and Pain Following Cataract Surgery
Initiation of the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop, follows the recently reported positive OPTIMIZE-1 trial results OPTIMIZE-2
About this update from Oculis Holding Ag
[{"type":"text","content":"Initiation of the second Phase 3 OPTIMIZE-2 trial with OCS-01 once daily eye drop, follows the recently reported positive OPTIMIZE-1 trial results OPTIMIZE-2 topline readout expected before end of 2024 to support NDA submissionOCS-01 is also being evaluated as potentially the first topical eye drop treatment for Diabetic Macular Edema (DME) in the DIAMOND program and for the treatment of Cystoid Macular Edema (CME) in the LEOPARD trial ZUG, Switzerland, and BOSTON, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis” or “the Company”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced First Patient First Visit (FPFV) in OCS-01 Phase 3 OPTIMIZE-2 trial for the treatment of inflammation and pain following cataract surgery. Data from the Phase 3 OPTIMIZE-2 trial is intended to support the Company’s NDA submission to the Food and Drug Administration (FDA). If approved, OCS-01 has the potential to be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery. The OPTIMIZE-2 (Once-daily Post-ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) is a multi-center, randomized, double-masked, vehicle-controlled Phase 3 trial evaluating OCS-01 for the treatment of inflammation and pain following cataract surgery. Similar to the OPTIMIZE-1 trial, patients in the second Phase 3 OPTIMIZE-2 trial will be treated with once-daily OCS-01 post-cataract surgery versus vehicle for 2 weeks. Primary endpoints are the absence of anterior chamber cells (inflammation) on Day 15 and absence of pain on Day 4. The OPTIMIZE-2 trial follows the positive topline results from the OPTIMIZE-1 trial showing that OCS-01 increased the percentage of patients who were inflammation free at Day 15 and had zero pain at Day 4 vs. vehicle with statistical significance (p","length":2359,"tagName":"div"}]