Brimochol PF achieves endpoints in phase 3 presbyopia trial
Click Here to Manage Email Alerts
Key takeaways:
- Brimochol PF achieved the primary endpoint based on improvement in binocular near visual acuity.
- The combination product was well tolerated with low headache rates.
Brimochol PF, a once-daily eye drop under evaluation for the treatment of presbyopia, achieved primary and secondary endpoints in the pivotal phase 3 BRIO-I clinical trial, according to a press release from Visus Therapeutics.
The preservative-free carbachol/brimonidine tartrate fixed-dose combination product achieved the prespecified FDA primary endpoint based on the proportion of participants who achieved a gain of at least 15 ETDRS letters in binocular near visual acuity without a loss of 5 letters or more at distance across all time points through hour 6.
In addition, statistical significance was achieved for the prespecified secondary endpoints of the proportion of participants who achieved a gain of 10 letters read at near distance and the proportion of participants who achieved at least 20/40 at near visual acuity.
BRIO-I was a three-arm randomized trial comprising 182 participants between the ages of 45 and 80 years at 15 U.S. sites. Brimochol PF was compared against carbachol monotherapy and brimonidine tartrate monotherapy in participants with emmetropic phakic or pseudophakic presbyopia.
No treatment-related serious adverse events were reported, and headache rates were less than 10%. Additionally, no participants discontinued treatment due to adverse events.
“With the completion of our BRIO-I study and positive phase 3 data in hand, we see a clear pathway forward,” Ben Bergo, co-founder and CEO of Visus Therapeutics, said in the release. “We believe the success of the study represents a strong opportunity to meet the market need for a true once-daily product with a very favorable tolerability profile.”
Read more about
Click Here to Manage Email Alerts