Visus Therapeutics Presents Topline Clinical Data from Phase 3 Pivotal BRIO-I Trial of BRIMOCHOL™ PF for the Treatment of Presbyopia at Eyecelerator
BIOMARKER
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1. Visus Therapeutics has presented topline data from its Phase 3 BRIO-I trial of BRIMOCHOL™ PF, a treatment for presbyopia.
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2. The trial met its FDA primary endpoint for binocular near visual acuity across multiple time points and showed no significant adverse events.
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3. BRIMOCHOL™ PF demonstrated a statistically significant reduction in pupil size at all time points up to 10 hours.
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4. The treatment also showed a significant improvement in distance vision at 8 hours, compared to active controls.
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5. Study participants reported greater effectiveness of BRIMOCHOL™ PF over its active controls.
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6. The trial evaluated the safety and efficacy of the preservative-free ophthalmic solution for presbyopia treatment.
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7. Visus Therapeutics CEO Ben Bergo sees a clear pathway forward with positive Phase 3 data.
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8.
BRIMOCHOL
™ PF is the first fixed-dose combination product to achieve statistically significant "contribution-of-elements" in presbyopia.
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9. The treatment was well-tolerated, with less than 10% experiencing headaches and no serious adverse events reported.
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10. Topline results from the ongoing Phase 3 BRIO-II study are expected in the second half of 2023.
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