Clearside Biomedical’s Asia-Pacific Partner, Arctic Vision, receives approval for suprachoroidal treatment for uveitic macular edema in Australia and Singapore

(Image Credit: AdobeStock)

Arctic Vision’s new drug applications for ARCATUS (triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit) have been approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of uveitic macular edema (UME).

ARCATUS or ARVN001, in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries is formally known as XIPERE in the United States and was developed by Clearside Biomedical.

XIPERE was approved by the US Food and Drug Administration in October 2021 and is commercially available in the US.

Arctic Vision is a China-based ophthalmic biotech that has the exclusive license for the commercialization and development of XIPERE (ARCATUS) in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. Bausch + Lomb has the exclusive license for the commercialization and development of XIPERE in the US and Canada.

George Lasezkay, PharmD, JD, president and CEO of Clearside Biomedical commented on the approval in a press release from the company.

“We congratulate our partner, Arctic Vision, for the outstanding progress advancing our product in the Asia-Pacific region. These global regulatory approvals confirm that our innovative SCS delivery platform enables the treatment of patients with sight-threatening eye diseases. We expect that retinal specialists across the world will use this in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of potential therapies.”

Clearside’s patented SCS Microinjectorcan delivers a wide variety of drug candidates into the suprachoroidal space, providing targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells, according to the company.¹

In July 2024, Arctic Vision announced positive topline results from its Phase 3 UME clinical trial in China.

The results from the phase 3 trial met the primary endpoint and secondary endpoints, with significantly better visual acuity improvement and edema control in the treatment arm over the sham arm. In the study, 38.5% of ARVN001-treated patients gained 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or more in vision vs 9.4% in the sham group. ARVN001-treated patients had a central subfield thickness (CST) reduction of 204.3 microns vs 1.6 microns in the sham group at week 24. Both reached statistical significance (p<0.001).²

In addition to these results, Artic Vision reported that the mean best corrected visual acuity (BCVA) gain was 9.6 letters at week 4 and 12.2 letters at week 24. The CST changes achieved over 200 microns reduction at week 4 and maintained the reduction to week 24. No ocular serious adverse events (SAEs) or new safety signals were reported.²

In addition, Arctic Vision is developing ARVN001 for other ocular retinal diseases, including diabetic macular edema.¹

References:

1. Clearside Biomedical Announces its Asia-Pacific Partner, Arctic Vision, Received Approval of Suprachoroidal Treatment for Uveitic Macular Edema in Australia and Singapore. Press Release. Published January 22, 2025. Accessed January 22, 2025.https://www.globenewswire.com/news-release/2025/01/22/3013351/0/en/Clearside-Biomedical-Announces-its-Asia-Pacific-Partner-Arctic-Vision-Received-Approval-of-Suprachoroidal-Treatment-for-Uveitic-Macular-Edema-in-Australia-and-Singapore.html

2. Crago, Sydney. Artic Vision, Clearside Biomedical partner, reports positive topline results from phase 3 ARCATUS trial. Published July 30, 2024. Accessed January 22, 2025. https://www.ophthalmologytimes.com/view/artic-vision-clearside-biomedical-partner-reports-positive-topline-results-from-phase-3-arcatus-trial