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Opus Genetics says LYNX-2 trial met primary endpoint

Opus Genetics (IRD) announced topline results from LYNX-2, a pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. The LYNX-2 study met its primary endpoint of a gain of three lines or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. In the study, 17.3% of patients treated with Phentolamine Ophthalmic Solution 0.75% achieved a greater than or equal to15-letter Early Treatment Diabetic Retinopathy Study improvement in Mesopic Low Contrast Distance Visual Acuity at Day 15, compared to 9.2% in the placebo group. Patient-reported benefit was observed at Day 15 in difficulty of seeing the road because of oncoming headlights and difficulty seeing due to glare when driving at dawn or dusk, in patients taking Phentolamine Ophthalmic Solution 0.75% compared to placebo when assessed by the validated Vision and Night Driving Questionnaire.

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