Clearside Biomedical, Inc. (CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, announced today positive safety results from Cohort 1 of OASIS, its ongoing Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) administered by suprachoroidal injection via Clearside’s SCS Microinjector® in six patients (n=6) with neovascular age-related macular degeneration (wet AMD).
The primary endpoints were achieved in Cohort 1, as the initial lowest planned dose of 0.03 mg CLS-AX was well tolerated with no serious adverse events and no drug related treatment emergent adverse events observed throughout the study period. There were no signs of inflammation, no vasculitis, no intraocular pressure (IOP) safety signals, no dispersion of drug into the vitreous, or any other drug related adverse events observed in any of the patients. The OASIS Safety Monitoring Committee has reviewed the data and the trial will advance to Cohort 2. Clearside expects to begin Cohort 2 patient screening for a dose of 0.1 mg CLS-AX in June 2021 with completion of this four month study period expected by the end of the year.
The current OASIS trial protocol includes a CLS-AX dose of 0.1 mg for Cohort 2 and 0.3 mg for Cohort 3, which equates to 3.3x and 10.0x the Cohort 1 dose of 0.03 mg. The Company expects to add a three-month extension study to follow patients in Cohort 2 and Cohort 3. Combined data from the multiple cohorts of the OASIS trial is planned to be presented at future medical meetings.