Tenpoint Therapeutics Ltd. Announces FDA Acceptance of New Drug Application for BRIMOCHOL™ PF for the Treatment of Presbyopia

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5:00 AM on Tuesday, June 3, 2025

The Associated Press

LONDON & SEATTLE--(BUSINESS WIRE)--Jun 3, 2025--

Tenpoint Therapeutics, Ltd. (“Tenpoint”), a global, clinical-stage biotechnology company focused on developing groundbreaking treatments to rejuvenate vision in the aging eye, today announces that the U.S. Food and Drug Administration (FDA) has accepted the 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 BRIMOCHOL™ PF. The FDA noted that it is not planning to hold an advisory committee meeting to discuss this application.

Tenpoint Therapeutics’ management, including Henric Bjarke, Chief Executive Officer, Ben Bergo, President & Chief Business Officer, and Melissa Epperly, Chief Financial Officer will participate at the Jefferies Global Healthcare Conference in New York from June 3 - 4, 2025.

“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,” said Henric Bjarke, Chief Executive Officer of Tenpoint Therapeutics. “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.”

About Tenpoint Therapeutics

Tenpoint Therapeutics Ltd. is a global, clinical-stage biotech company developing groundbreaking treatments to rejuvenate vision in the aging eye. Its pipeline includes paradigm-shifting treatments for ophthalmic indications with the greatest need and global market potential, including presbyopia, cataracts, and geographic atrophy. Its lead asset, BRIMOCHOL™ PF, is a novel pupil-modulating therapeutic designed to correct the loss of near vision associated with presbyopia, a condition that afflicts approximately two billion people globally. Tenpoint has completed two large Phase 3 pivotal trials (BRIO-I and BRIO-II) for BRIMOCHOL™ PF and has submitted an NDA to the US FDA. A privately held company, Tenpoint Therapeutics is backed by AdBio Partners, AlbionVC, British Business Bank (formerly British Patient Capital), Eight Roads, EQT Life Sciences, F-Prime Capital, Hillhouse Capital Management, Qiming Venture Partners USA, Sofinnova Partners, and Wille AG. To learn more, visit tenpointtherapeutics.com and connect on LinkedIn.

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