Orasis Pharmaceuticals submitted a new drug application to the FDA for CSF-1 (pilocarpine hydrochloride 0.4%).
What is CSF-1?
CSF-1 is a proprietary, preservative-free formulation of low-dose pilocarpine and multi-faceted vehicle designed to achieve an optimal balance between efficacy, safety and comfort. (via)
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.
What did clinical trials show?
The phase 3 clinical trials (NEAR-1 and NEAR-2) 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.
Any side effects?
The most common side effect was headache (6.8%) and instillation site pain (5.8%).
How is this different from Vuity?
CSF-1 is a lower concentration of pilocarpine, preservative-free, and can be dosed up to twice a day.
When might this be approved?
An anticipated FDA approval would be in the fourth quarter of this year. Stay tuned!