HONG KONG, Dec 20, 2023 - (ACN Newswire) - Ocumension Therapeutics ("Ocumension" or the "Company", together with its subsidiaries, collectively the "Group", stock code: 1477), a leading China ophthalmic pharmaceutical platform company, is pleased to announce that, OT-703 (ILUVIEN®, fluocinolone intravitreal implant), an injectable, non-biodegradable fluocinolone acetate intravitreal implant for the treatment of diabetic macular edema (DME) has recently obtained an approval from the Pharmacy and Poisons Board of Hong Kong for its registration as a pharmaceutical product in Hong Kong in accordance with the Pharmacy and Poisons Ordinance (Cap. 138 of the Laws of Hong Kong) (the "Pharmacy and Poisons Ordinance").
OT-703, namely the 190 microgram fluocinolone acetonide intravitreal implant in applicator (0.19 mg), is an injectable, non-biodegradable fluocinolone acetate intravitreal implant used for the treatment of DME by delivering a continuous microdose of the non-proprietary corticosteroid fluocinolone acetonide (FAc) in the eye, for up to 36 months.
In addition, OT-703 has received regulatory approval from the United States Food and Drug Administration (FDA) and is marketed under the trade name "ILUVIEN®". Also, OT-703 is the only FDA-approved corticosteroid intraocular implant for the treatment of DME with a three-year sustained-release period.
In April 2021, Ocumension and Alimera Sciences, Inc. ("Alimera") entered into an exclusive license agreement, according to which the Company obtained the exclusive licensed rights from Alimera in relation to the development and commercialization of ILUVIEN® in Greater China, South Korea and 11 countries in Southeast Asia.
Dr. Lian Yong CHEN, Chairman and Non-executive Director said, "DME is a common complication of diabetes and often leads to severe central vision damage in patients. Upon successful registration as a pharmaceutical product, OT-703 is allowed to be sold, offered for sale, distributed, and possessed in Hong Kong for the Pharmacy and Poisons Ordinance. We are pleased to receive the approval for for marketing OT-703 in Hong Kong, and we hope that more of our products will enter the Hong Kong market, to help more DME patients in the future."