Visus Therapeutics Launches and Announces Clinical Development Program for Novel Presbyopia Eye Drop
Visus Therapeutics announced its launch and clinical development program for a novel eye drop designed to restore the loss of near vision associated with presbyopia. Visus’ lead product candidate is Brimochol, a proprietary formulation that combines two 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 research led by Herb Kaufman, MD, an ophthalmologist who is responsible for more than 15 landmark innovations in the field of eye care and beyond, according to Visus Therapeutics.
Five clinical studies have been conducted evaluating the safety and efficacy of Brimochol. In the most recent 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.4 Phase 2 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,” Ben Bergo, co-founder, president and chief executive officer of Visus Therapeutics, said in a company news release. “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 nonclinical studies demonstrate that this proprietary formulation supports a robust and extended duration of effect of 8-12 hours4,5,” co-founder Rhett Schiffman, MD, MS, MHSA, chief medical officer and head of research and development at Visus Therapeutics, said in the news release. “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.”
Visus brings deep ophthalmology experience to its team. Dr. Schiffman is a board-certified internist and ophthalmologist and uveitis-trained specialist. Dr. Schiffman previously served as vice president of global drug development and therapeutic area head of ophthalmology at Allergan, chief medical officer at Neurotech Pharmaceuticals, and chief medical officer and head of research and development at Envisia Therapeutics (since acquired by Aerie Pharmaceuticals).
Robert Sambursky, MD, is a board-certified ophthalmologist with corneal and external disease specialty training. Dr. Sambursky is also chairman of the board of directors and president and chief executive officer of Lumos Diagnostics, previously RPS Diagnostics. RPS Diagnostics and Planet Innovation were early investors for Visus.
Visus also announced the formation of its clinical advisory board, appointing industry veteran Eric Donnenfeld, MD, as its leader. Dr. Donnenfeld is an internationally recognized ophthalmologist, serving on the editorial board of nine journals and having participated in more than 40 FDA clinical studies. He is the founding partner of Ophthalmic Consultants of Long Island and Connecticut and also serves as Clinical Professor of Ophthalmology at New York University Medical Center.
“I am very pleased to partner with the leadership team at Visus Therapeutics as they work to advance their pipeline of ophthalmic therapeutics,” said Dr. Donnenfeld. “Brimochol employs an innovative approach and the pharmacologic treatment of presbyopia would be a significant benefit for patients.”