The U.S. Food and Drug Administration has accepted Orasis Pharmaceuticals’ New Drug Application (for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%). The FDA has assigned a Prescription Drug User Fee Act goal date of October 22, 2023.
The NDA is based on data from the Phase 3 NEAR-1 and NEAR-2 clinical trials, involving more than 600 patients, which evaluated the efficacy and safety of CSF-1. Both trials met their primary and key secondary endpoints on Day 8, achieving statistically significant 3-line or more gain in distance-corrected near visual acuity, and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events of headache and instillation site pain occurred in only 6.8% and 5.8% of participants, respectively. Of all CSF-1 participants, only 2.6% reported moderate treatment-related adverse events. All other adverse events were mild.
Read the full press release here.
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