Published in Pipeline

FDA accepts Orasis NDA for CSF-1 to treat presbyopia

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Orasis Pharmaceuticals, Inc. announced that the FDA has accepted its new drug application (NDA) for CSF-1 (pilocarpine hydrochloride 0.4%) for the treatment of presbyopia.

This acceptance follows the company’s NDA submission to the FDA in January 2023.

Tell me about CSF-1.

CSF-1 is an investigational, proprietary, preservative-free formulation of low-dose pilocarpine and multi-faceted vehicle designed to achieve an optimal balance between efficacy, safety, and comfort.

How does it work?

CSF-1 improves near visual acuity by pupil modulation, resulting in a "pinhole effect" and an increase in the depth of field—thus increasing the ability to focus on near objects.

The eye drop can be dosed up to twice a day.

How did it perform in clinical trials?

The multi-center, randomized, double-masked, vehicle-controlled phase 3 clinical trials NEAR-1 (NCT04599933) and NEAR-2 (NCT04599972) involved over 600 patients. 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.

Common treatment-related adverse events (AEs) included headache (6.8%) and pain at the instillation site (5.8%).

Now what?

The FDA has designated October 22, 2023, as the Prescription Drug User Fee Act (PDUFA) date. If approved, CSF-1 would become the second prescription drop for the treatment of presbyopia.