According to the company, the investigational, novel eye drop candidate was assigned a PDUFA goal date of October 22, 2023.
Orasis Pharmaceuticals today announced the FDA has accepted for review its New Drug Application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%).
According to a news release, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023.
"We are encouraged by the acceptance of our NDA filing as we progress towards our mission of reshaping vision possibilities for the millions of people in the U.S. living with presbyopia, or blurry near vision," Elad Kedar, CEO of Orasis Pharmaceuticals, said in the release. "We look forward to working with the FDA towards approval and commercial launch of CSF-1."
According to the company, its 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 (DCNVA), and no loss of 1-line or more in distance visual acuity.
The company noted in its news release 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.