Clearside Biomedical, Inc. (NASDAQ: CLSD) a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, reported Tuesday 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). Clearside Biomedical stock price surged about 40% during Tuesday early trading session.
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. According to the Company, 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.
“We are very encouraged by the Cohort 1 results of the OASIS trial and we are immediately beginning Cohort 2 enrollment as planned,” said Thomas A. Ciulla, M.D., MBA, Chief Medical Officer and Chief Development Officer. “The initial data from Cohort 1 clearly achieved our safety and tolerability endpoints. While still early and recognizing there are a limited number of patients, we believe the Cohort 1 data supports our hypothesis that the combination of targeted and compartmentalized suprachoroidal delivery and the potent pan-VEGF attributes of axitinib may facilitate an effective treatment option for patients suffering from wet AMD.”
“CLS-AX was well-tolerated and these initial results in this heavily treatment-experienced group of wet AMD patients are promising. I look forward to the continued clinical advancement of CLS-AX at the planned higher doses to further explore potential benefits in visual acuity, ocular anatomy and durability,” added Mark R. Barakat, M.D., Director of Research, Retinal Consultants of Arizona; Clinical Assistant Professor, University of Arizona College of Medicine, Phoenix.