Orasis Pharmaceuticals has submitted a new drug application to the FDA for CSF-1, its investigational eye drop candidate for presbyopia, according to a press release.
The drop is a is a preservative-free formulation of low-dose pilocarpine that creates a pinhole effect and increases depth of field to improve the ability to focus on close objects.
The NDA was based on data from the phase 3 NEAR-1 and NEAR-2 trials, which evaluated the efficacy and safety of CSF-1 in more than 600 participants. Both trials met primary and key secondary endpoints at day 8 by achieving a three line or more gain in