Orasis Pharmaceuticals has announced that the FDA has accepted for review its New Drug Application (NDA) for CSF-1, an investigational eye drop candidate designed to treat presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023, for its decision. The NDA is based on data from two Phase 3 clinical trials, NEAR-1 and NEAR-2, which evaluated the efficacy and safety of CSF-1 on over 600 patients. Both trials achieved statistically significant improvements in near visual acuity with no loss of distance visual acuity. The most common treatment-related adverse events were headache and instillation site pain, which occurred in only 6.8% and 5.8% of participants, respectively. Orasis Pharmaceuticals is looking forward to working with the FDA towards approval and commercial launch of CSF-1.
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