Arctic Vision has dosed the initial set of subjects in the Phase III clinical trial of its experimental therapy, ARVN001, to treat macular oedema linked with uveitis (UME) in China.
An injectable suspension of triamcinolone acetonide, ARVN001 acts on the suprachoroidal space (SCS).
The SCS Microinjector technology can potentially provide the drug to the suprachoroidal space, which is positioned between the choroid and sclera, the eye’s outer protective layer.
A suprachoroidal injection is claimed to offer a quick and appropriate dispersion of the drug to the back of the eye. This allows the therapy to work for a longer period and reduce the risk of damage to the nearby healthy regions of the eye.
The therapy is currently approved as XIPERE by the US Food and Drug Administration (FDA) to treat UME.
Last March, Arctic Vision obtained the exclusive licence from US-based ophthalmology firm Clearside Medical to develop and market XIPERE in Greater China and South Korea.
The territories were later expanded to include ASEAN countries, India, Australia and New Zealand.
The randomised, placebo-controlled, double-blind trial will assess the efficacy and safety of ARVN001 in UME patients.
According to data from the Phase III PEACHTREE trial in the US, the therapy showed favourable efficacy and safety profile.
Treatment with ARVN001 for 24 weeks also offered substantial enhancement in vision, noticeable and durable reduction of oedema, and reduced adverse event rates.
Arctic Vision chief medical officer Dr Qing Liu said: “No therapy has been approved in China for UME treatment.
“With the validated efficacy and safety of SCS microinjection, as well as its operational convenience, we remain very confident in advancing the study to address the unmet needs for UME patients, and broadening the application of SCS microinjection in treatment for more ocular fundus diseases.”
In July 2021, Arctic Vision signed a research partnership with the ophthalmology department of the University of Hong Kong to develop neuroprotective therapies for glaucoma.