Orasis Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for investigational CSF-1 (low dose pilocarpine hydrochloride 0.4%).
In the Phase 3 NEAR-1 and NEAR-2 clinical trials evaluating CSF-1, the primary and key secondary endpoints were met.
The most common treatment-related adverse events were headache (6.8%) and instillation site pain (5.8%). Moderate treatment-related adverse events were reported in 2.6% of all participants treated with CSF-1. All other adverse events were mild.
“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 in a press 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.”
Read the full press release here.
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