The U.S. Food and Drug Administration has approved YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% for the treatment of presbyopia in adults, according to a press release.
Formerly known as BRIMOCHOL PF, YUVEZZI is the first and only dual-agent eye drop approved for this condition. The company expects the product to be broadly available in the United States in the second quarter of 2026.
The approval is supported by results from two Phase 3 clinical trials. In the BRIO I study, the combination therapy showed superior benefit compared with each active ingredient, meeting the FDA requirement for fixed-dose combinations. In the second study, BRIO II, which used a vehicle control, YUVEZZI met all primary endpoints, demonstrating statistically significant ≥3-line improvements in binocular uncorrected near visual acuity over 8 hours, without a loss of ≥1 line in binocular uncorrected distance visual acuity.
Safety findings from BRIO II included more than 72,000 treatment days, making it the longest presbyopia safety study conducted to date. No treatment-related serious adverse events were reported. The most common side effects were headache, impaired vision, and temporary eye pain or irritation.
Reports of ocular hyperemia (eye redness) were low in both Phase 3 studies. In BRIO II, the rate of eye redness was 2.8% in participants receiving YUVEZZI, compared with 10.7% in those treated with carbachol alone.
Read the full press release here.
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