Tenpoint Therapeutics announced positive topline results from its Phase 3 BRIO-II trial of BRIMOCHOL™ PF, a carbachol/brimonidine tartrate eye drop for presbyopia. The drug met its primary endpoints, demonstrating statistically significant near vision improvement over eight hours and a good safety profile in a 12-month at-home dosing study. This paves the way for a US regulatory filing in the first half of 2025.
These results are important because they address a significant unmet need for the estimated two billion people globally with presbyopia. Current treatment options, like reading glasses or surgery, are often inconvenient or invasive. A well-tolerated, effective eye drop offers a potentially game-changing alternative for managing age-related near vision loss and improving patients’ quality of life by restoring reading ability and improving daily tasks. The long-term safety data, gathered over 12 months of daily dosing, is particularly compelling, addressing a key consideration for chronic use medications.
BRIO-II, a three-arm, double-masked study involving 629 participants, compared BRIMOCHOL™ PF to carbachol monotherapy and a vehicle. The study showed not only visual acuity improvement but also increased reading speed and better patient-reported outcomes. The drug’s mechanism of action involves reducing pupil size, creating a pinhole effect that improves near vision focus. Importantly, the brimonidine component appears to enhance carbachol’s effects while mitigating potential side effects like eye redness.
The positive Phase 3 results position BRIMOCHOL™ PF for potential regulatory approval and subsequent commercial launch, which could significantly disrupt the current presbyopia treatment landscape. If approved, this novel eye drop could become a widely adopted first-line therapy, offering millions of people a convenient and effective way to manage age-related vision decline. This could also establish Tenpoint Therapeutics as a leader in the ophthalmic therapeutics market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
