Arctic Vision receives approval in Australia and Singapore for uveitic macular oedema treatment ARVN001
ARCATUS or ARVN001 was developed by Clearside Biomedical and commercialised in the Asia-Pacific region by Arctic Vision
Image credit: ©Alexander Limbach – stock.adobe.com
Arctic Vision’s new drug applications for its triamcinolone acetonide 4 mg/0.1 mL injection suspension vial kit, known in the APAC as ARVN001 or ARCATUS, have been approved by the Therapeutic Goods Administration of Australia and the Health Sciences Authority in Singapore for the treatment of uveitic macular oedema, according to a news release.1
A China-based ophthalmic biotech, Arctic Vision holds an exclusive development and commercialisation license for ARCATUS in Greater China, South Korea, Australia, New Zealand, India and the ASEAN Countries. The product 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, where Bausch + Lomb holds development and commercialisation rights.
Clearside’s patented microinjector can delivers a wide variety of drug candidates into the suprachoroidal space (SCS), providing targeted delivery to potentially improve efficacy and compartmentalisation of medication to reduce or eliminate toxic effects on non-diseased cells, according to the company.1
George Lasezkay, PharmD, JD, president and CEO of Clearside Biomedical, commented on the APAC approval in the 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,” he said. “We expect that retinal specialists across the world will use this in-office, repeatable, non-surgical procedure for the targeted and compartmentalised delivery of a wide variety of potential therapies.”
In July 2024, Arctic Vision announced positive topline results from its Phase 3 uveitic macular oedema 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 oedema 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, Arctic 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
Arctic Vision is developing ARVN001 for the treatment of other ocular retinal diseases including diabetic macular oedema.1
References:
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
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
