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糖尿病性黄斑水肿(DME)
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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
Zhi Tong Cai Jing· 2026-01-19 23:35
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(01477.HK):OT-703于海南博鳌进行的真实世界研究完成患者入组
Ge Long Hui· 2026-01-19 23:29
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 a small amount of non-proprietary corticosteroid for up to 36 months to treat DME [2] - It is the only FDA-approved intravitreal implant that offers a sustained release for up to 3 years for the treatment of DME [2] - The product has received regulatory approval from the FDA and is marketed under the brand name "ILUVIEN®" [2] Group 2: Licensing and Approvals - In April 2021, the company entered into an exclusive licensing agreement with Alimera Sciences, Inc., granting it exclusive rights for the development and commercialization of ILUVIEN® in Greater China, South Korea, and 11 Southeast Asian countries [2] - In December 2023, OT-703 received approval from the Hong Kong Pharmacy and Poisons Board to be registered as a pharmaceutical product under the Pharmacy and Poisons Ordinance [2]