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Orasis Pharmaceuticals’ NDA for CSF-1 for presbyopia accepted by FDA

Today, Orasis Pharmaceuticals announced that the U.S. Food and Drug Adminstration (FDA) has accepted its New Drug Application (NDA) for its investigational low dose pilocarpine hydrochloride 0.4% (CSF-1) eye drop for the treatment of presbyopia. The Prescription Drug User Fee Act (PDUFA) goal date of October 22, 2023 was assigned to the novel eye drop.1

“We are encouraged by the acceptance of our NDA filing as we progress towards our mission of reshaping vision possibilities for the millions of people in the U.S. living with presbyopia, or blurry near-vision,” said Elad Kedar, Chief Executive Officer of Orasis Pharmaceuticals, in a press release. “We look forward to working with the FDA towards approval and commercial launch of CSF-1.”


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