Tenpoint Therapeutics, Ltd. announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for Brimochol PF for the treatment of presbyopia. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026, for the drug. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application, according to a Tenpoint Therapeutics press release. 

“This milestone marks a significant step forward in our transition toward becoming a commercial-stage company, and we look forward to collaborating closely with the Agency throughout the review process,” says Henric Bjarke, chief executive officer of Tenpoint Therapeutics, in the press release. “As the only combination product of its kind, Brimochol PF offers the potential for a best-in-class product, achievable through a unique and differentiated profile. With our commercial leadership team now in place, we are fully engaged in launch preparations as we anticipate a product availability in 1H 2026.”