FDA accepts IND for presbyopia drop
The FDA has accepted an investigational new drug application for Brimochol, according to a press release from Visus Therapeutics.
Brimochol (carbachol and brimonidine tartrate) is a once-daily eye drop to correct the loss of near vision from presbyopia, the release said. Visus will now begin a phase 2 clinical trial in the U.S.
“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,” Ben Bergo, co-founder and CEO of Visus, said in the release.
Brimochol’s safety and efficacy have been demonstrated through six clinical studies involving more than 200 patients, the release said. Overall, the studies showed an average near visual acuity improvement of five lines or more on the Jaeger eye chart with an 8-hour duration.