Enrollment underway in early-stage wet AMD trial
The first patients have been enrolled in a phase 1/2a clinical trial of CLS-AX for the treatment of neovascular age-related macular degeneration, according to a press release from Clearside Biomedical.
The open-label, dose-escalation OASIS trial will assess the safety and tolerability of a single dose of CLS-AX (axitinib injectable suspension) via suprachoroidal injection across three patient cohorts for 3 months. Secondary trial endpoints include evaluation of the pharmacokinetics, visual function, ocular anatomy and need for additional treatment with intravitreal aflibercept.
“We believe that axitinib, a small molecule tyrosine kinase inhibitor, could provide safety and efficacy comparable to, or better than, current standard of care,” George Lasezkay, PharmD, JD, president and CEO of Clearside Biomedical, said in the release. “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.”
Data from the first patient cohort are expected in mid-2021.