Restoring the eye's
conventional outflow pathway,
at the tissue that controls it.
OF-01 is an investigational once-daily topical combination of 4-PBA and TUDCA, designed to restore conventional outflow by targeting trabecular meshwork cellular stress and fibrosis. It has not been tested in humans.
OF-01 is an investigational new drug candidate. It has not been approved by the U.S. Food and Drug Administration or any other regulatory authority and has not been demonstrated to be safe or effective for any use. All data described on this website are preclinical. Information provided is for scientific, corporate, and qualified-investor purposes only and is not medical advice.
seconds until the next person is diagnosed with glaucoma, worldwide
0 since you opened this page
About one every 18 seconds, derived from projected global prevalence growth of 76 million (2020) to 112 million (2040). Tham et al., Ophthalmology 2014.
18 seconds until the next glaucoma diagnosis. 0 diagnoses since you opened this page.
Pressure is managed. The tissue that causes it is not.
Every approved glaucoma therapy lowers intraocular pressure, by suppressing aqueous production or redirecting it through alternative routes. None is approved to restore the function of the trabecular meshwork, the tissue whose dysfunction raises pressure in the first place.
OF-01 is designed to act at the source of outflow resistance, intended to be used alongside existing therapy rather than to replace it.
Once-daily drop
A conventional multi-dose bottle, no device or procedure.
Targets the tissue
Designed to restore trabecular meshwork function at the source.
Capital-efficient path
505(b)(2) pathway leverages prior findings for both components.
A once-daily eye drop, in a standard bottle.
A sterile topical ophthalmic solution, fixed-dose 4-PBA + TUDCA, delivered from a conventional multi-dose dropper. No device, no procedure. The design intent is to reduce cellular stress and fibrosis within the trabecular meshwork and thereby improve conventional outflow.
A capital-efficient path to first-in-human.
Both components are previously characterized. A 505(b)(2) application lets OF-01 rely, in part, on the FDA's prior findings for the PBA + TUDCA combination, so new work is ocular-specific.
Developing a therapy designed to restore outflow at the source.
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