VIDEO: Orasis shares FDA, clinical study updates
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ATLANTA — The FDA has accepted Orasis Pharmaceuticals’ new drug application for CSF-1, and the company shared positive phase 3 trial results, according to Orasis president and chief operating officer Paul Smith at SECO 100.
The FDA assigned a Prescription Drug User Fee Act goal date in October for Orasis’ CSF-1 for the treatment of presbyopia, Smith said. NEAR-1 study results show efficacy “as early as 20 minutes after the first dose [that] extends out to a full 8 hours.”
He added: “CSF-1 is a low-dose pilocarpine, 0.4%. It is formulated preservative-free at a near neutral pH and includes multiple lubricating agents, so it’s intended to meet presbyopia patients where they are.”
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