Chinese Regulators Accept NDA for Arcatus (Xipere) in Uveitic Macular Edema

Clearside Biomedical announced Feb. 20 that Chinese regulators had accepted for review the new drug application (NDA) filed by Clearside’s Asia-Pacific partner, Arctic Vision, for Arcatus, known as Xipere in the US, in uveitic macular edema.

Xipere, a suspension of triamcinolone acetonide for injection into the suprachoroidal space, was approved in the US in 2021. It is also approved in Australia and Singapore.

According to Clearside’s website, Bausch + Lomb has licensed Xipere for the US and Canada, while Arctic Vision holds the rights in Taiwan, Hong Kong, Macau, South Korea, Australia, New Zealand, India, and the ASEAN countries. Arctic Vision licensed the rights in mainland China to Japan’s Santen in November 2024 for up to $85 million in upfront and milestone payments.

Arctic Vision is developing Arcatus for other ocular diseases, including diabetic macular edema.

Clearside is based in Alpharetta, Georgia. Arctic Vision is based in Shanghai, China.