Core Viewpoint - The announcement highlights the completion of patient enrollment for a real-world study of OT-703 (ILUVIEN), a non-biodegradable fluocinolone acetonide intravitreal implant for treating diabetic macular edema (DME) in Hainan, China [1] Group 1: Product Overview - OT-703 is an injectable, non-biodegradable fluocinolone acetonide implant that provides continuous release of the drug for up to 36 months [1] - It is the only FDA-approved intravitreal implant for DME that offers a sustained release for three years [1] 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" [1] - 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 [1] Group 3: Licensing Agreement - In April 2021, the company entered into an exclusive licensing agreement with Alimera Sciences, Inc., granting the company exclusive rights to develop and commercialize ILUVIEN in Greater China, South Korea, and 11 Southeast Asian countries [1] Group 4: Study Details - The real-world study involved a total of 195 patients enrolled in Hainan, China [1]
欧康维视生物-B：OT-703于海南博鰲进行的真实世界研究完成患者入组