Clearside Biomedical Inc (NASDAQ:CLSD) is one of the biggest gainers in the pre-market session on Tuesday. The stock is up 25% over the past month.
Major Trigger:
Clearside Biomedical Announces Positive Safety Results from Cohort 1 of OASIS Phase 1/2a Clinical Trial of CLS-AX (axitinib injectable suspension) for the Treatment of Wet AMD
Key Highlights:
- 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.
Key Quote:
“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.”
Market Reaction
As of 8:43, CLSD is trading at $4.52, up 49.67%. So far more than 6.40 million shares have exchanged hands.
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