The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CSF-1 (pilocarpine hydrochloride), a novel corrective eye drop candidate, for the treatment of presbyopia in adults.
CSF-1 is a preservative-free solution that contains a proprietary combination of low-dose pilocarpine hydrochloride 0.4% and multifaceted vehicle. The investigational drug is designed to improve near vision in patients with presbyopia without compromising distance or night vision.
The NDA is supported by data from the multicenter, double-masked, vehicle-controlled phase 3 NEAR-1 (ClinicalTrials.gov Identifier: NCT04599933) and NEAR-2 (ClinicalTrials.gov Identifier: NCT04599972) trials, which included 613 patients aged 45 to 64 years with presbyopia. Patients were randomly assigned to receive 1 drop bilaterally twice daily of either CSF-1 or placebo for approximately 2 weeks.
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Findings from both trials showed that treatment with CSF-1 met the primary and key secondary endpoints demonstrating a statistically significant 3-line or more gain in distance-corrected near visual acuity on day 8, and no loss of 1-line or more in distance visual acuity. The most common treatment-related adverse events were headache and instillation sight pain.
“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 US living with presbyopia, or blurry near vision,” said Elad Kedar, CEO of Orasis Pharmaceuticals. “We look forward to working with the FDA towards approval and commercial launch of CSF-1.”
A Prescription Drug User Fee Act target date of October 22, 2023 has been set for the application.
Reference
FDA accepts Orasis Pharmaceuticals’ New Drug Application for CSF-1 for the treatment of presbyopia. News release. Orasis Pharmaceuticals. Accessed February 21, 2023. https://www.prnewswire.com/news-releases/fda-accepts-orasis-pharmaceuticals-new-drug-application-for-csf-1-for-the-treatment-of-presbyopia-301750185.html.
This article originally appeared on MPR
