Clearside and Arctic Vision Report Data From Trial of Arcatis to Treat Uveitic Macular Edema in China

Clearside Biomedical announced that its partner, Arctic Vision, reported topline results from its phase 3 clinical trial of Arcatus (ARVN001) for the treatment of uveitic macular edema in China. In addition, Arctic Vision announced that new drug applications for Arcatus have been officially accepted in Australia and Singapore.

According to Clearside, Arcatus is Arctic Vision’s name for Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use, which was originally developed by Clearside.

Arctic Vision is a specialty ophthalmology company based in China that has the exclusive license for the commercialization and development of Xipere in Greater China, South Korea, Australia, New Zealand, India, and member states of ASEAN, the Association of Southeast Asian Nations.

On July 26, Arctic Vision announced the phase 3 trial results.

As summarized in Clearside’s press release, the results showed that the trial met its primary endpoint and secondary endpoints and demonstrated significantly better visual acuity improvement and edema control in the treatment arm versus the sham arm. Specific findings included the following:

• In 38.5% of ARVN001-treated patients gained 15 or more “Early Treatment Diabetic Retinopathy Study” letters in vision versus 9.4% of patients in the sham group.
• At week 24, central subfield thickness (CST) reduction was 204.3 microns in ARVN001-treated patients versus 1.6 microns in the sham group.
• Both findings reached statistical significance (P < .001).
• The mean best corrected visual acuity gain was 9.6 letters at week 4 and 12.2 letters at week 24.
• The CST changes achieved a reduction of more than 200 microns at week 4 and maintained the reduction to week 24.
• There were no ocular serious adverse events or new safety signals reported.

In the United States and Canada, Bausch + Lomb has the exclusive license for the commercialization and development of Xipere. Xipere was approved by the FDA in October 2021 and is commercially available in the United States, noted Clearside.