FDA accepts Bausch Health, Clearside Biomedical's resubmitted Xipere NDA

PDUFA action date of October 30, 2021, is assigned for investigational therapy with a proposed indication of treatment of macular edema associated with uveitis.

Bausch + Lomb and Clearside Biomedical Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application for triamcinolone acetonide suprachoroidal injectable suspension (Xipere).

The agency determined that the filing is a Class 2 resubmission and assigned a Prescription Drug User Fee Act (PDUFA) action date of October 30, 2021, for the investigational therapy with a proposed indication of treatment of macular oedema associated with uveitis.

“If approved by the FDA, [triamcinolone acetonide suprachoroidal injectable suspension] would be the first therapy available utilising the suprachoroidal space for patients suffering from macular edema associated with uveitis, which is the leading cause of vision loss in people with uveitis,” said Yolande Barnard, vice president and general manager, US Pharmaceuticals, Bausch + Lomb, in a prepared statement.

“If approved, [this] would be our first commercial product and the first approved drug to be delivered into the suprachoroidal space (SCS),” added Clearside’s President and CEO George Lasezkay, PharmD, JD.

The novel treatment option is designed for suprachoroidal administration via Clearside’s proprietary SCS microinjector that provides access to the back of the eye, where sight-threatening disease often occurs.

An affiliate of Bausch Health acquired the exclusive license for the commercialisation and development of triamcinolone acetonide suprachoroidal injectable suspension in the United States and Canada in October 2019.

The Bausch Health affiliate also has exclusive options for the right to commercialise and develop the novel treatment option in the European Union, the United Kingdom, Australia and New Zealand, and/or South America and Mexico. Arctic Vision has the exclusive license for its commercialisation and development of in Greater China and South Korea. Triamcinolone acetonide suprachoroidal injectable suspension is not yet approved in any jurisdiction.