Orasis Pharmaceuticals announced that the FDA has approved the company's new drug application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%) for review. A Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023 has been set by the FDA.
"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, Chief Executive Officer of Orasis Pharmaceuticals, said in a company news release. "We look forward to working with the FDA towards approval and commercial launch of CSF-1."
Orasis Pharmaceuticals' new drug application (NDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%) is based on the results of the NEAR-1 and NEAR-2 phase 3 clinical trials, which involved over 600 patients and assessed the efficacy and safety of the drug. Both trials successfully met their primary and key secondary endpoints on Day 8, with a statistically significant gain of 3-line or more in distance-corrected near visual acuity (DCNVA) and no loss of 1-line or more in distance visual acuity.
In the case of CSF-1, the most frequent treatment-related negative effects were headache and instillation site pain, which only affected 6.8% and 5.8% of participants, respectively. Only 2.6% of all CSF-1 recipients reported experiencing moderate treatment-related adverse events, while all other adverse effects were mild.
CSF-1 is a preservative-free, proprietary formula that contains a low dosage of pilocarpine and a multifaceted vehicle. It is intended to strike the right balance between effectiveness, safety, and comfort. By modulating the pupil, CSF-1 enhances near visual acuity, resulting in a "pinhole effect" that increases depth of field and improves the ability to concentrate on close-up items.