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BRIMOCHOL PF Achieves Durable Near Vision Improvement in Presbyopia
BRIMOCHOL PF offers lasting near vision improvement for presbyopia, demonstrating robust efficacy and safety in a landmark Phase 3 study.
A combination product of preservative-free carbachol 2.75% and brimonidine tartrate 0.1% (BRIMOCHOL PF) achieved durable improvement in functional near vision for patients with presbyopia, with no drug-waning effect over 12 months of dosing in the Phase 3 BRIO-II study.1
Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, these data showed individuals treated with BRIMOCHOL PF achieved clinically meaningful improvement in near vision and clinically relevant miosis, with most patients experiencing a full day of improved near vision.
“Once-daily BRIMOCHOL PF provides up to 8 hours of functional near vision—offering robust efficacy and full-day duration,” wrote the investigative team, led by Sherif El-Harazi, MD, MPH, medical director and founder at Lugene Eye Institute.1 “BRIO II is the world’s largest and longest (12 months) safety study in presbyopia, with more than 70,000 dosing days.”
On April 8, 2025, Tenpoint Therapeutics, Ltd. announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for BRIMOCHOL PF for presbyopia. With approval, BRIMOCHOL PF would mark the first combination therapy for presbyopia, which currently impacts around 2 billion individuals worldwide.2
In the prospective, multi-center, crossover, masked BRIO II study, 629 emmetropic presbyopes aged 45 to 80 years were randomized to receive once-daily topical BRIMOCHOL PF or vehicle over six months. For a subsequent six months, participants on vehicle were crossed over to BRIMOCHOL PF, while those initially on BRIMOCHOL PF remained on treatment.1
The study’s primary analysis involved the proportion of individuals achieving ≥3 lines of improvement in binocular uncorrected near visual acuity without 5 letters of worsening in binocular distance visual acuity for BRIMOCHOL PF vs vehicle. Pupil diameter and participant-reported treatment perception comprised the secondary endpoints.
Results showed BRIMOCHOL PF demonstrated statistically superior improvement to vehicle in near and distance visual acuity to 8 hours (P <.001), without tachyphylaxis to 12 months. Reports of hyperemia were also significantly lower with BRIMOCHOL PF vs. vehicle (P =.008) over 12 months.
Further analysis showed BRIMOCHOL PF significantly benefited reading speed (P <.001) and National Eye Institute Refractive Error Quality of Life Instrument—42 (NEI RQL-42) near and current vision subscales. Approximately 82% of participants rated their frequency of at-home use as often or on a regular basis, and 83% rated effectiveness on near vision as “good” or “excellent.”
Safety analyses showed no treatment-related serious adverse events linked to BRIMOCHOL PF. The most common adverse events following a single dose of BRIMOCHOL PF
“Patients reported the duration was ‘just right’ and wanted to use BRIMOCHOL PF 5 days per week,” El-Harazi and colleagues wrote.1 “BRIMOCHOL PF demonstrated a good tolerability profile with no unexpected safety signals with up to 12-month exposure.”
References
El-Harazi S, Evans DG, Williams J, Schiffman RM. Vehicle-Controlled Phase 3 Safety and Efficacy Evaluation of Preservative-Free Carbachol 2.75%/Brimonidine Tartrate 0.1% in Presbyopia. Poster presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. April 25-28, 2025. Los Angeles, CA.
Livingston R. Tenpoint Therapeutics submits NDA for Brimochol PF to treat presbyopia. HCP Live. April 8, 2025. Accessed April 26, 2025. https://www.hcplive.com/view/tenpoint-therapeutics-submits-nda-for-brimochol-pf-to-treat-presbyopia.
