Clearside Biomedical announced that the first patients have been enrolled in its phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with wet age-related macular degeneration (AMD). Clinical sites, all based in the United States, are activated and currently screening wet AMD patients for this phase 1/2a trial, known as OASIS, involving CLS-AX, a proprietary suspension of axitinib for suprachoroidal injection.
“The enrollment of the first patients for our OASIS trial is a key milestone for Clearside as we execute our strategy to expand our ophthalmology pipeline with innovative and relevant opportunities targeting critical medical needs through the suprachoroidal space (SCS),” George Lasezkay, PharmD., JD, President and Chief Executive Officer, said in a company news release. “We believe that axitinib, a small molecule tyrosine kinase inhibitor (TKI), could provide safety and efficacy comparable to, or better than, current standard of care. And by delivering axitinib as a suspension into the suprachoroidal space using our in-office, non-surgical SCS Microinjector, we may potentially extend the duration of therapeutic action and reduce or relieve the profound treatment burden for wet AMD patients. We expect data from our first cohort of patients in mid-2021.”
OASIS is a phase 1/2a open-label, dose-escalation study in wet AMD patients to assess the safety and tolerability of a single dose of CLS-AX administered by suprachoroidal injection. 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 3 month period.
The study design consists of 3 cohorts of 5 patients each (n=15). Cohort 1 participants will receive 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).
In preclinical studies, CLS-AX delivered suprachoroidally was observed to be well tolerated and showed significant ocular tissue concentrations over time. These characteristics, if demonstrated clinically, may support the potential for suprachoroidal axitinib to reduce or relieve the treatment burden for patients suffering from wet AMD.