AAO 2023: Visus Therapeutics presents pivotal BRIO-I studies for presbyopia

Ben Bergo, CEO of Visus Therapeutics, spoke with Ophthalmology Times about the study on presbyopia, BRIO-I at this year's American Academy of Ophthalmology meeting. Here's what he had to say about the most recent data and new trials expected in the years ahead.

Video Transcript

Editor's note - This transcript has been edited for clarity.

Ben Bergo:

Hi I'm Ben Bergo, CEO of Visus Therapeutics, and it's great to be here in San Francisco with AAO for 2023.

Visus Therapeutics is a clinical-stage company with a lead program in presbyopia, and a pipeline of multitargeted medicines for the front and back of the eye. In the second quarter of this year, we presented data for the first time from BRIO-I, our first of 2 pivotal studies in presbyopia. From that study, BRIMOCHOL demonstrated contribution-of-elements, and is the first drug candidate to do that. We also met the prespecified primary endpoint for US FDA, met the the prespecified primary endpoint for, for [the] UK and Europe, and the drug was well tolerated. And beyond that, we have a pipeline of other ophthalmic drug candidates under development.

Some highlights from BRIO-I: we showed robust responder rates from early in the day, through to the latter parts of the day, to the to the latter time measurements in this study. Approximately 50% of subjects were able to graduate, from moderate to mild, or severe to mild, presbyopia, and achieve 2040 or better vision at 10 hours. We also conducted some additional sensitivity analysis, which I was able to present on yesterday at Eyecelerator. And we did some analysis across both dark and light irides and showed really no differences in responder rates. And that's pretty powerful, because we do know that with pilocarpine, which binds to melanin, you can see a lower responder rate with lighter-colored irides.

We also did some additional analyses on starting baseline visual acuity and really show it again, no differences across those subgroups.
So whether you're a mild or moderate or severe presbyope, you can expect to see robust gains with BRIMOCHOL in your near vision throughout the day. So that was BRIO-I. We are still enrolling in BRIO-II, our second study that has an efficacy component at the start. And then is a 6-month plus 6-month safety study. We look forward to filing in the second half of next year, and then through to approval in the second half of 2025.

Beyond that, our next candidate are coming through is a disease-modifying drug for presbyopia and cataract, which moves beyond our meiotic strategy which is BRIMOCHOL, obviously. That drug we're looking to progress into the clinic in the first half of 2025.