Clearside announces TGA of Australia accepted Arctic Vision’s NDA for Arcatus

Clearside Biomedical announced that the Therapeutic Goods Administration, TGA, of Australia has formally accepted Arctic Vision’s new drug application, NDA, for suprachoroidal use of Arcatus for the treatment of Uveitic Macular Edema. Arctic Vision is a specialty ophthalmology company based in China that has the exclusive license for the commercialization and development of XIPERE. “Acceptance of the NDA in Australia is additional validation of suprachoroidal administration as an innovative, recognized form of ophthalmic drug delivery and another step towards the global commercialization of XIPERE,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside. “With approval in the U.S., regulatory review ongoing in Australia, and plans to gradually submit applications in more countries in its territories, our partner Arctic Vision continues to expand access for patients to the only product approved for the treatment of macular edema associated with uveitis.”