FDA Accepts New Drug Application for Presbyopia-Correcting Eye Drop BRIMOCHOL

Visus Therapeutics Inc. has announced the U.S. Food and Drug Administration (FDA) acceptance of the company’s Investigational New Drug Application (IND) to proceed with the clinical development program for BRIMOCHOL™. BRIMOCHOL is designed to be a once-daily eye drop to correct for the loss of near vision associated with presbyopia. Under this IND, Visus will initiate its planned Phase 2 clinical trial in the U.S. immediately.

BRIMOCHOL is a combination eye drop with a proprietary formulation that combines carbachol (a cholinergic miotic agent) and brimonidine tartrate (an alpha-2 agonist), two well-studied and FDA-approved medicines. Carbachol produces a “pinhole effect”, which reduces the size of the pupil and allows the light rays focused on the retina to enter the eye, thereby sharpening images. The addition of brimonidine to carbachol is designed to provide several benefits, including longer duration of the pinhole effect and a lower incidence of the side effects typically induced by miotic agents.

“The FDA’s acceptance of the IND for BRIMOCHOL represents an important step forward for Visus Therapeutics and, more importantly, for the estimated 123 million U.S. adults living with presbyopia,” said Ben Bergo, co-founder and chief executive officer of Visus. “We are excited to begin dosing patients in the Phase 2 clinical study, which we believe will validate BRIMOCHOL as a well-tolerated solution that meets patients’ desire for a long-lasting near vision treatment option.”

Six clinical studies have been conducted in more than 200 patients evaluating the safety and efficacy of BRIMOCHOL. These studies demonstrated an average near visual acuity improvement of five lines or more on the Jaeger eye chart, with a duration of a minimum of eight hours post-dose. The most recent study, published in 2019 in the International Journal of Ophthalmic Research, evaluated 57 patients and reported that BRIMOCHOL’s proprietary combination of carbachol and brimonidine delivered sustained improvement in near visual acuity for a minimum of eight hours. It also showed an average improvement of more than five lines on the Jaeger eye chart and no reports of brow ache or loss in distance vision. Visus has confirmed a 505(b)(2) pathway with the FDA.