Research & Development
Arctic Vision treats first set of patients in China in Phase III study of ARVN001 for macular edema associated with uveitis
23 November 2021 -

Chinese biotech company Arctic Vision said on Monday that it has dosed the first set of patients in China under the Phase III study of ARVN001 for the treatment of macular edema associated with uveitis (UME), the leading cause of vision loss and blindness.

The company added that ARVN001 (triamcinolone acetonide suprachoroidal injectable suspension, known as XIPERE in the U.S.) is a first-in-class investigational therapy directly targeting the suprachoroidal space (SCS). ARVN001 is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the suprachoroidal space.

On 25 October 2021, the New Drug Application (NDA) for XIPERE for UME treatment was approved by the US Food and Drug Administration (FDA) and the product is expected to be launched soon. The US Phase III pivotal study (PEACHTREE)1 results have demonstrated good efficacy and safety profile of ARVN001, with significant improvement in vision.

Under the randomized double-blind placebo-controlled Phase III trial in China, the company plans to evaluate the efficacy and safety of ARVN001 in patients with UME. The trial is the first clinical registration study targeting the indication of UME in China and the first clinical application of SCS microinjection in China.

The leading principal investigator of the Phase III study of ARVN001 is Professor Peizeng Yang, an uveitis expert in China. He is the head of Ophthalmology at the First Affiliated Hospital of Chongqing Medical University, director of the Chongqing Key Laboratory of Ophthalmology as well as vice-chairman of the Chinese Ophthalmological Society.