Clearside Biomedical Shares Soar On Encouraging Safety Profile For Injectable Axitinib In Wet AMD Patients

Clearside Biomedical Inc CLSD has announced positive safety results from Cohort 1 (n=6) of OASIS Phase 1/2a trial of CLS-AX (axitinib injectable suspension) for neovascular age-related macular degeneration (wet AMD).
The primary endpoints were achieved, as the initial lowest planned dose of 0.03 mg CLS-AX was well-tolerated with no serious adverse events, drug-related treatment-emergent adverse events observed.
There were no signs of inflammation, no vasculitis, no intraocular pressure safety signals, no dispersion of drug into the vitreous, or any other drug-related adverse events observed in any of the patients.
One month after receiving CLS-AX, five of six patients exhibited improvement in BCVA, each gaining four or more letters, with the mean ETDRS BCVA score of all patients increasing by +4.7 letters.
In Cohort 1, no patients required additional treatment with Regeneron Pharmaceuticals Inc's REGN Eylea (aflibercept) at the one-month visit after CLS-AX.
Two patients went three months after CLS-AX without additional treatment with aflibercept, and BCVA improved by 5 and 7 ETDRS letters for these patients.
Four patients received additional treatment with aflibercept at the two-month visit after CLS-AX.
The trial will advance to Cohort 2, with patient screening for a dose of 0.1 mg to start in June, with completion expected by the end of the year.
Price Action: CLSD shares are up 56.3% at $4.72 during the premarket session on the last check Tuesday.