Ocumension Therapeutics has announced that the New Drug Application (NDA) for the core product in its pipeline, OT-401 (Sterile non-bioerodible intravitreal implant, Product  name: YUTIO), has been officially approved by the National Pharmaceutical Administration (NMPA) for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye (chronic NIU-PS).

This is the first new drug in Ocumension's pipeline to be approved for marketing and is currently the potential best-in-class therapy for the treatment of this indication in China.

Non-infectious uveitis is a chronic form of uveitis that can lead to a variety of complications such as cataracts and glaucoma, and when the inflammation is not promptly controlled, it can also lead to impaired vision or even permanent vision loss. The complexity of the clinical presentation of non-infectious uveitis and the high degree of similarity between subtypes pose significant diagnostic and differential problems.

Liu Ye, Chief Executive Officer of Ocumension, said: "With its low dose intraocular administration and stable drug release over a period of up to 36 months, YUTIO is the first and only new drug approved by the FDA for the treatment of chronic non-infectious uveitis involving the posterior segment of the eye that can release fluphenazole for up to 36 months. This approval is an important event not only for Ocumension , but also for Chinese patients with YUTIO. This dangerous and stubborn disease will now have a long-term effective control method. Everyone will be able to return to a normal life without the fear of losing their sight."