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First Patient Enrolled in LEOPARD, an Investigator-Initiated Trial, with OCS-01 Eye Drops for the Treatment of Cystoid Macular Edema
LEOPARD trial initiation follows recent positive data from OCS-01 eye drops from the Stage 1 Phase 3 DIAMOND trial in patients with Diabetic Macular Edema
About this update from Oculis Holding Ag
[{"type":"text","content":"LEOPARD trial initiation follows recent positive data from OCS-01 eye drops from the Stage 1 Phase 3 DIAMOND trial in patients with Diabetic Macular Edema (DME)Cystoid Macular Edema (CME) can result from uveitis or from post-surgical complicationsCME is one of the most significant causes of vision loss after ocular surgery1 and approximately 28% of patients who undergo ocular surgery, including patients with diabetes, uveitis and other risk factors, have a higher risk of CME2. In addition, CME can also occur in about 40% of patients with posterior or pan-uveitis3 ZUG, Switzerland, and BOSTON, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, announces that the first patient has been enrolled in the investigator-initiated LEOPARD trial evaluating the potential of OCS-01 eye drops, Oculis’ novel high concentration preservative-free topical OPTIREACH formulation of dexamethasone, for the treatment of cystoid macular edema (CME). CME may occur as a complication of ocular conditions, including uveitis and ocular surgery, and is a leading cause of vision loss worldwide. It is one of the most significant causes of postoperative vision loss after cataract surgery1. Approximately 28% of patients who undergo ocular surgery, including patients with diabetes, uveitis and other risk factors, have a higher risk of developing CME following the procedure2. Up to 56% of high-risk patients may experience clinically significant CME following ocular surgery1. The LEOPARD trial, administratively sponsored by the Global Ophthalmic Research Center (Los Altos, California) and led by Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, aims to evaluate the efficacy and safety profile of OCS-01 eye drops in the management of two different forms of CME: Uveitic Macular Edema (UME) and Post-Surgical Macular Edema (PSME). It is a prospective, multi-center, open label, single-armed trial which plans on enrolling 24 eligible subjects (12 with UME and 12 with PSME). Two different doses will be used, and the total treatment period is 24 weeks. The primary endpoints, which will be assessed at 12 weeks, are improvement in central subfield thickness (CST) and ...