Core Viewpoint - The company has successfully completed the enrollment of 195 patients in a real-world study for its product OT-703 (ILUVIEN), which is used to treat diabetic macular edema (DME) [1] Group 1: Product Information - OT-703 is an injectable, non-biodegradable fluocinolone acetonide intravitreal implant that provides continuous release of the drug for up to 36 months [2] - It is the only FDA-approved corticosteroid intravitreal implant for DME treatment that offers a sustained release for up to three years [2] - The product has been licensed exclusively for development and commercialization in Greater China, South Korea, and 11 Southeast Asian countries through an agreement with Alimera Sciences, Inc. [2] Group 2: Regulatory Approvals - OT-703 has received regulatory approval from the U.S. Food and Drug Administration (FDA) and is marketed under the brand name "ILUVIEN" [2] - In December 2023, OT-703 was approved by the Hong Kong Pharmacy and Poisons Board for registration as a pharmaceutical product under the Pharmacy and Poisons Ordinance [2]
欧康维视生物-B(01477):OT-703于海南博鰲进行的真实世界研究完成患者入组