Visus Therapeutics presents positive phase 2 data from their presbyopia trials

Ben Bergo, CEO of Visus Therapeutics, gives a company update on the company's presented phase 2 data, and what's next in the pipeline.

"We look forward to providing further updates through this year and into next year with data read outs to file in the middle of 2023."

Last year, Visus Therapeutics completed VIVID, the company’s Phase 2 study of three novel topical ophthalmic formulations under investigation for the treatment of presbyopia.

At this year's 2022 ASCRS meeting in Washington, D.C., Ben Bergo, CEO of Visus, gave an update on that data and the next steps in the pipeline.

VIVID Phase 2 Trial Topline Highlights:

  • In the per protocol population, a minimum of 83% of subjects treated with BRIMOCHOL, BRIMOCHOL F or Carbachol F achieved the endpoint of 3 lines of improvement in binocular near visual acuity under mesopic conditions without losing 1 line of distance vision at 1 hour. A minimum of 82%, 52% and 35% of subjects met this same endpoint at 3, 7 and 9 hours, respectively.
  • In key secondary endpoints, BRIMOCHOL and BRIMOCHOL F achieved a mean improvement in binocular near visual acuity of a minimum of 18 ETDRS letters, almost 4 lines, as early as 30 minutes and a minimum of 12 letters at 9 hours.
  • BRIMOCHOL, BRIMOCHOL F and Carbachol F were well-tolerated with no unexpected adverse events. Adverse events exceeding 5% included temporary burning and stinging upon instillation, headache and brow ache. No serious adverse events were reported.

The company is in two pivotal Phase 3 trials (BRIO-I and BRIO-II) for its lead asset, BRIMOCHOL™ PF. BRIO-I and BRIO-II are double-masked, randomized, multi-center, safety and efficacy studies expected to enroll emmetropic phakic and pseudophakic presbyopic patients (approximately 170 and 500 respectively).