Orasis Pharmaceuticals submits NDA for investigational novel eye drop candidate for treatment of presbyopia

The phase 3 NEAR-1 and NEAR-2 clinical trials, involving over 600 patients, met primary and key secondary endpoints and serve as the basis for the submission.

Orasis Pharmaceuticals today announced that it has submitted a New Drug Application (NDA) to the FDA for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%).

Elad Kedar, CEO of Orasis Pharmaceuticals, pointed out in a news release that the NDA submission marks a key milestone for Orasis as the company advances CSF-1 towards commercialization and achieving its goal of reshaping vision possibilities for patients.

“With more than 120 million people in the U.S. affected, we look forward to working with the FDA during its review process to ultimately provide an alternative treatment option for patients seeking flexibility in managing their presbyopia,” Kedar said in the release.

According to the company, the 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 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.

The Phase 3 NEAR-1 and NEAR-2 top-line results were previously announced earlier this year, and additional details of these studies will be presented at future medical meetings.

About CSF-1

CSF-1 is a novel corrective eye drop candidate being investigated for the treatment of presbyopia. 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. 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.