March 18, 2021 — Visus Therapeutics, Inc., has announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to proceed with the clinical development program for Brimochol (a proprietary combination of carbachol and brimonidine tartrate), its investigational drug designed as a once-daily eye drop to correct for the loss of near vision associated with presbyopia. Under this IND, the company will initiate its planned Phase 2 clinical trial in the U.S.

“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,” says 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.” 

This news follows the recent announcement from earlier this month in which Visus shared the close of $36 million Series A Preferred Stock financing. Johnson & Johnson Innovation, RTW Investments, LP, and Wille AG participated in the round, with additional participation from the company’s existing shareholders.

Visus has shared that six clinical studies have been conducted in more than 200 patients evaluating the safety and efficacy of the drug, which 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 company has confirmed a 505(b)(2) pathway with the FDA. 

For more information: visustx.com.