Brimochol PF achieves endpoints in second phase 3 presbyopia trial

Key takeaways:

• Brimochol PF was well tolerated with no treatment-related serious adverse events.
• Tenpoint plans to submit an FDA new drug application in the first half of 2025.

Patients with presbyopia experienced improvements in near vision after treatment with Brimochol PF in a second phase 3 pivotal trial, according to a press release from Tenpoint Therapeutics.

The BRIO-II trial met prespecified primary endpoints agreed to by the FDA, European Medicines Agency and UK Medicines and Healthcare products Regulatory Agency. Brimochol PF (carbachol/brimonidine tartrate fixed-dose combination) demonstrated improvements in near vision vs. vehicle at all study time points up to 8 hours (P < .008). Additionally, it demonstrated reduction in pupil size at all time points.

The eye drop was well tolerated through 12 months of daily dosing, and there were no treatment-related serious adverse events.

BRIO-II was a three-arm randomized trial that compared the safety and efficacy of Brimochol PF with carbachol monotherapy topical ophthalmic solution and vehicle topical ophthalmic solution. The study included 629 patients at 47 trial sites in the United States.

Tenpoint plans to file a new drug application with the FDA in the first half of 2025 and anticipates a potential launch in 2026, according to the release.

“Tenpoint Therapeutics is the only company in the presbyopia category to demonstrate contribution of elements with Brimochol PF, paving the way for a combination drug approval that offers the additional benefits of brimonidine,” Rhett Schiffman, MD, MS, MHSA, chief medical officer and head of research and development at Tenpoint, said in the release. “In our studies, brimonidine increased the magnitude and duration of action of carbachol and reduced the incidence of hyperemia over carbachol alone. Brimochol PF is the only presbyopia-correcting eye drop to have gone through a 12-month safety study. It was very well tolerated over 12 months of continuous dosing, and subjects in the study reported very high compliance during the study and a strong willingness to use the drug.”

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