Eye drops developed by Opus Genetics have significantly improved night vision in people who struggle to drive in the dark, according to results from two late-stage studies.
In the first trial, researchers enrolled 145 patients with poor vision in dim or dark settings along with symptoms such as glare, halos, and starbursts.
Participants received either 0.75% phentolamine ophthalmic solution or a placebo for eight or 15 days.
After eight days, 13% of patients given the eye drops improved by at least three lines on eye charts, compared with 3% in the placebo group.
By day 15, the improvement rate rose to 21% in the treatment group, while the placebo group remained at 3%.
Patients also reported less trouble with glare, halos and starbursts. By day 15, those using the eye drops showed a statistically significant improvement in overall night vision problems.
Researchers said the drops work by acting on a muscle in the iris and causing moderate pupil constriction that can last for at least 20 hours.
Many of the participants had developed these vision issues after procedures such as LASIK surgery.
Opus Genetics also reported encouraging early results from a second Phase III trial. The company said patients experienced a better ability to see the road under oncoming headlights and improved vision in dawn or dusk glare.
The US Food and Drug Administration has granted Fast Track designation to the eye drops for treating chronic night driving impairment, which could speed up the approval process.
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