Brimochol PF FDA Approval Status
Last updated by Judith Stewart, BPharm on June 11, 2025.
FDA Approved: No
Brand name: Brimochol PF
Generic name: brimonidine tartrate and carbachol
Dosage form: Ophthalmic Solution
Company: Tenpoint Therapeutics, Ltd.
Treatment for: Presbyopia
Brimochol PF (brimonidine tartrate and carbachol) is an alpha-adrenergic agonist and cholinomimetic combination in development for the treatment of presbyopia.
- Presbyopia is an age-related, near-vision loss condition that occurs due to a loss of elasticity in the lens of the eye. Symptoms include blurry near vision, eye strain, and headache.
- Brimochol PF contains a combination of brimonidine tartrate and carbachol, both well-established FDA-approved treatments for glaucoma. Brimonidine tartrate works by preventing pupil dilation, while carbachol works as a miotic agent for pupil constriction. In combination they work in the treatment of presbyopia by producing a “pinhole effect,” which reduces the size of the pupil so that only centrally focused light rays are able to enter the eye. The result is improvement in depth of focus and sharpening of near and distant images, and clarity of vision for near tasks.
- A New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) for Brimochol PF for the treatment of presbyopia. The NDA was supported by positive data from the first Phase 3 BRIO-I study that demonstrated the benefit of the combination therapy over the individual components. In a second study, the vehicle-controlled Phase 3 BRIO-II study, Brimochol PF achieved all primary and secondary near vision improvement endpoints with statistically significant improvement in binocular uncorrected near visual acuity over 8 hours.
- The NDA for Brimochol PF has been accepted by the FDA, and has been assigned a Prescription Drug User Fee Act (PDUFA) date of January 28, 2026.
Development timeline for Brimochol PF
Further information
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