ASCRS Live: Visus Therapeutics shares data from Phase 3 pivotal study, BRIO-I

Ben Bergo, CEO of Visus Therapeutics discussed the data presented at ASCRS 2023 for the company's Phase 3 pivotal study, BRIO-I with our onsite team.

Video transcript

Editor’s note: Transcript lightly edited for clarity.

Ben Bergo:

Hi, I'm Ben Bergo, CEO of Visus Therapeutics and looking forward to sharing some brief updates that I presented yesterday at Eyecelerator as part of ASCRS. I shared some very exciting data from our Phase 3 pivotal study, BRIO-I, which just completed in March of this year.

This was a crossover design comparing BRIMOCHOL to carbachol and brimonidine, which are the two active ingredients in BRIMOCHOL. I was very, very pleased to share at the conference that we met the US FDA primary endpoint, where we were required to show contribution of elements, that is that BRIMOCHOL could outperform and was superior to its two active components, again, carbachol and brimonidine. So we did that in the US.

We also demonstrated contribution of elements for Europe and that was an area under the curve analysis actually between half an hour and 8 hours and we demonstrate that again with statistical significance also. So we have a clear pathway now for the US for a combination drug approval in this category of presbyopia-correcting drops. We also have a pathway for a combination drug approval for UK and Europe.

In addition to that I shared some of the safety and tolerability data from the study. There were no serious adverse events [AEs] reported nor discontinuations due to AEs. There was a little burning and stinging on installation but otherwise a favorable profile and no hyperemia from the drop. Importantly, near the end of each dosing day after the subjects had been in the clinic for 10 hours, we queried the subjects on what they thought of that day's drop. On duration, they rated BRIMOCHOL as 'just right' in terms of what they perceive the duration to be which is important in this category. On effectiveness, they rated BRIMOCHOL as very effective at improving their near vision, and they indicated that they want to use BRIMOCHOL approximately 5 days per week. We look forward to completing the enrollment and then moving towards filing with our second Phase 3 study and finally in the middle of next year and towards approval in the first half of 2025. Again, we're excited with the results and look forward to providing further updates into the future.