Clearside Biomedical announced completion of dosing in the first cohort of OASIS, its ongoing phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with wet age-related macular degeneration (AMD).
OASIS is a US-based, multicenter, open-label, dose-escalation trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. The first cohort of patients have received aflibercept at their first visit and a single dose of CLS-AX at their second visit 1 month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for 3 months following the administration of CLS-AX.
“We are pleased to have made rapid progress enrolling patients in our OASIS trial evaluating the use of axitinib, a highly-potent small molecule tyrosine kinase inhibitor (TKI), administered by suprachoroidal injection,” Thomas A. Ciulla, MD, MBA, Chief Medical Officer and Chief Development Officer, said in a company news release. “This progress was made possible through the combined efforts and commitment by patients, investigators, advisors and our internal team. We believe that by combining the high potency and pan-VEGF attributes of axitinib with our proprietary CLS-AX formulation and delivery via our SCS Microinjector, we may extend the duration of therapeutic action and reduce or relieve the profound treatment burden for wet AMD patients. We expect to report initial safety data from this first cohort of patients in mid-2021 and continue on to a higher dose in the next cohort in the second half of the year.”
About the OASIS Phase 1/2a Clinical Trial
OASIS is an open-label, dose-escalation phase 1/2a trial in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection via Clearside’s SCS Microinjector. Eligible patients are those who demonstrate stable visual acuity following two or more previous injections with an intravitreal anti-VEGF agent. Enrolled patients initially receive aflibercept at the first visit followed by a single dose of CLS-AX at the second visit 1 month later. The primary endpoint for the trial will assess the safety and tolerability of CLS-AX for the 3 months following the administration of CLS-AX, and secondary endpoints will evaluate the pharmacokinetics, visual function, ocular anatomy, and the need for additional treatment with intravitreal aflibercept during the three-month period.
The study design is planned with 3 cohorts of approximately 5 patients each (n=15). Cohort 1 participants received the lowest dose, 0.03 mg of axitinib delivered via suprachoroidal injection. Dose escalation will then proceed following review of the safety data by the Safety Monitoring Committee and their recommendation to advance to the next higher dose cohort. Additional information on the phase 1/2a trial can be found on https://clinicaltrials.gov (NCT04626128).