- Wednesday, Clearside Biomedical Inc CLSD announced positive results from its OASIS Phase 1/2a trial of CLS-AX (axitinib injectable suspension) in neovascular age-related macular degeneration (wet AMD) patients.
- HC Wainwright views the 6-month results as very encouraging, considering that the enrolled patients have active subfoveal choroidal neovascularization (CNV) secondary to AMD with fluid.
- Hence the analyst has increased the probability of approval for CLS-AX to 25% from 20%, with the current estimated market value of the firm being $390 million, reiterating the Buy rating with a raised price target of $6 from $5.
- CLS-AX was well tolerated and showed a benign safety profile across all time points and doses. Interim data from the Extension Study in Cohorts 3 and 4 showed that the supplemental anti-VEGF injection-free rate was 88% (7 of 8 patients) to Month 5 and 75% (3 of 4 patients) to Month 6.
- Compared to patients’ 6- month anti-VEGF therapy before receiving CLS-AX, there was a 90% reduction in treatment burden.
- Management expects to report the final 6-month data from all 12 patients in the Extension Study in 1Q23.
- Price Action: CLSD shares are up 4.69% at $1.34 on the last check Thursday.
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