Eye drops developed by Opus Genetics significantly improved night vision in people who had trouble driving in the dark, according to data from two late-stage studies.
For the first trial, researchers recruited 145 patients with impaired visual acuity in dim or dark settings and symptoms of glare, halos, and starbursts. They received either the Opus eye drops containing 0.75% phentolamine ophthalmic solution daily or a placebo, for either eight or 15 days.
After eight days, 13% of study participants who got the phentolamine drops achieved a gain of at least three lines, or 15 letters, on eye charts, compared with 3% of the placebo group. By day 15, 21% who got the drug had seen such an improvement with no change for placebo at 3%.
Patients were also asked to rate their overall night vision problems on a scale of 1-7 with 7 being the most severe. Those treated with phentolamine were at 4.3 by day 8 and 3.3 after 15 days, considered a statistically significant improvement over the placebo group at 4.6 and 4.3, respectively.
By day 15, those who received the Opus Genetics drops also reported significantly less trouble with glare, halos, and starbursts than those treated with placebo.
By acting on a muscle in the iris, the eye drops produce moderate, sustained pupil constriction lasting at least 20 hours, researchers reported in The American Journal of Ophthalmology.
Many of the patients were experiencing their symptoms as after-effects of procedures to reshape the cornea, such as LASIK surgery to improve near- or far-sightedness or astigmatism, the researchers noted.
The company also announced encouraging initial results from a second Phase III trial of the eye drops.
In the second trial, “we also saw functional improvements in difficulty of seeing the road because of oncoming headlights; and difficulty seeing due to glare when driving at dawn or dusk, as reported by patients in the trial,” Dr. Jay Pepose, Opus Genetics' chief medical adviser, said in a statement.
The U.S. Food and Drug Administration has granted Fast Track designation for the eye drops as a treatment of significant chronic night driving impairment, according to the manufacturer's website. The designation, given to drugs that treat a serious condition or address an unmet medical need, can speed the process of seeking approval.
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