Presbyopia is the loss of near vision associated with aging, affecting approximately 123 million adults in the United States. While there are currently no FDA-approved medications, a novel eye drop treatment may soon be in the works. Visus Therapeutics Inc. has announced its launch and clinical development program for a lead candidate BRIMOCHOL™. The proprietary formulation combines two well-studied, FDA-approved pharmaceuticals: carbachol and brimonidine tartrate.

Visus recently completed the acquisition of all patent assets underpinning the development of BRIMOCHOL, which is based on pioneering research led by Herb Kaufman, M.D., a celebrated ophthalmologist who is responsible for more than 15 landmark innovations in the field of eye care and beyond.

Five clinical studies have been conducted evaluating the safety and efficacy of BRIMOCHOL. In the most recent clinical study of 57 patients, BRIMOCHOL demonstrated statistically significant improvement in near visual acuity of a 5 Jaeger-line or greater gain, with the effect lasting at least 12 hours.The same study found that BRIMOCHOL was well tolerated with no reports of headache or browache in this proprietary combination. Phase II trials are slated to commence in early 2021.

“The billions of people globally who suffer from presbyopia struggle with simple, everyday activities – such as reading a menu in a restaurant or using a mobile phone – representing a tremendous unmet need in the eye care segment,” said Ben Bergo, co-founder, president and chief executive officer of Visus Therapeutics. “We are very excited to advance the clinical development program for BRIMOCHOL with the hope of bringing the therapy to market and helping restore near vision for millions of adults globally.”

“The previously published clinical studies and our own extensive non-clinical studies demonstrate that this proprietary formulation supports a robust and extended duration of effect of 8-12 hours,” said co-founder Rhett Schiffman, M.D., M.S., M.H.S.A., chief medical officer and head of research and development at Visus Therapeutics. “The data also suggest that, unlike other combination drop candidates in this space, pivotal studies of BRIMOCHOL are expected to demonstrate that the individual drugs will contribute significantly to the overall effect of the combination product on near visual acuity.”

Read the full press release here.

VIA: OPHTHALMOLOGY WEB