OCUMENSION-B (01477): OT-703 Completes Patient Enrollment for Real-World Study in Boao, Hainan

Stock News
01/20

The Group's product, OT-703 (ILUVIEN®, fluocinolone acetonide intravitreal implant), an injectable, non-biodegradable implant for treating diabetic macular edema (DME), has recently completed the enrollment of a total of 195 patients for its real-world study conducted in the Boao Lecheng International Medical Tourism Pilot Zone, Hainan Province, People's Republic of China. OT-703, a 190-microgram fluocinolone acetonide intravitreal implant (0.19 mg), is an injectable, non-biodegradable product designed to treat DME by continuously releasing a microdose of the non-proprietary corticosteroid, fluocinolone acetonide (FAc), into the eye for up to 36 months. It has received regulatory approval from the U.S. Food and Drug Administration (FDA) and is marketed under the trade name "ILUVIEN®." OT-703 is the only corticosteroid intraocular implant approved by the FDA for treating DME with a sustained release duration of up to three years. In April 2021, the Company entered into an exclusive license agreement with Alimera Sciences, Inc. (Alimera), granting the Company exclusive rights to develop and commercialize ILUVIEN® in Greater China, South Korea, and 11 Southeast Asian countries. In December 2023, OT-703 received approval from the Pharmacy and Poisons Board of Hong Kong, allowing it to be registered as a pharmaceutical product in Hong Kong under Chapter 138 of the Hong Kong Ordinance, the Pharmacy and Poisons Ordinance.

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