Clearside Biomedical announced that its licensing partner, Aura Biosciences, has dosed the first patient in its phase 2 clinical trial evaluating the safety and efficacy of suprachoroidal administration of AU-011 as a potential first-line treatment for patients with primary choroidal melanoma. Aura is using Clearside’s SCS Microinjector to deliver AU-011 into the suprachoroidal space (SCS).
Aura also announced that AU-011 passed the Safety Review for the first dose escalation cohort, which demonstrated favorable safety data with no safety findings and no adverse events noted. Aura’s preclinical data on suprachoroidal injection of AU-011 presented at the Association for Research in Vision and Ophthalmology conference can be accessed here.
“With this trial initiation, we are on track to have three product candidates delivered via our SCS Microinjector in four clinical trials this year,” Thomas A. Ciulla, MD, MBA, Chief Medical Officer and Chief Development Officer, said in a company news release. “Choroidal melanoma is a rare and aggressive type of eye cancer and is the most common primary intraocular tumor in adults. Aura is a leader in their field and there is an unmet need for a new first-line treatment option for early stage choroidal melanoma. We are excited by ocular oncologists’ interest in suprachoroidal delivery and look forward to Aura’s continued progress.”
About Clearside’s SCS Microinjector
Clearside’s patented, proprietary suprachoroidal space (SCS) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Clearside’s proprietary SCS Microinjector can be used to inject a wide variety of drug candidates that are specifically formulated to be delivered via suprachoroidal injection. The SCS Microinjector provides targeted delivery to potentially improve efficacy and compartmentalization of medication to reduce or eliminate toxic effects on non-diseased cells. The SCS Microinjector is composed of a syringe and two 30-gauge hollow microneedles of varying lengths, each less than 1.2 millimeters, within a custom-designed hub that optimizes insertion and suprachoroidal administration of drugs.