Orasis submits new drug application for presbyopia drop
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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.
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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 distance-corrected near visual acuity and no loss of one line or more in distance visual acuity.
Among those who received the drop, 2.6% reported moderate treatment-related adverse events. The most common treatment-related adverse events were headache and instillation site pain.
“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,” Elad Kedar, CEO of Orasis Pharmaceuticals, said in the release. “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.”
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