ORASIS PHARMACEUTICALS SUBMITS NEW DRUG APPLICATION FOR INVESTIGATIONAL NOVEL EYE DROP CANDIDATE, CSF-1, FOR THE TREATMENT OF PRESBYOPIA

- Presbyopia is the loss of ability to focus on near objects as a result of the natural aging process and affects more than 120 million people in the U.S.

- 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

PONTE VEDRA, Fla., Jan. 3, 2023 - Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%).

"This NDA submission is a significant milestone for Orasis as we advance CSF-1 towards commercialization and achieving our goal of reshaping vision possibilities for patients," said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals. "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."

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.

Read the rest of the press release here on Orasis’ website or from a PDF here.

Shared by Tyler Stowater, board member of Orasis Pharmaceuticals.