New eye drops developed by US-based Opus Genetics have shown encouraging results in late-stage clinical trials for people experiencing difficulties with night vision, including glare, halos and starbursts from bright lights.
According to a Reuters report, Phase 3 trial results showed that the eye drops improved vision in people who struggled to see in low-light or dark conditions.
The first trial involved 145 participants who experienced night-time vision problems, including glare, halos and starbursts. Participants received either 0.75% phentolamine eye drops or a placebo daily for eight or 15 days.
After eight days, 13% of participants receiving the drug showed an improvement of at least three lines, or 15 letters, on an eye chart, compared with 3% in the placebo group. By the 15th day, the improvement rate among those receiving the eye drops had risen to 21%, while it remained at 3% in the placebo group.
Participants also rated the severity of their night-vision problems on a scale of one to seven. The average score among those using the eye drops fell to 4.3 on day eight and 3.3 on day 15, compared with 4.6 and 4.3 respectively in the placebo group.
By day 15, participants using phentolamine also reported significant reductions in problems caused by glare, halos and starbursts.
Researchers say the drops act on a muscle in the iris, causing the pupil to constrict moderately and consistently. The effect may last for at least 20 hours.
Many participants in the study had developed night-vision problems after treatments that alter the shape of the cornea, including LASIK surgery, which is commonly used to correct refractive errors.
Opus Genetics has also reported encouraging preliminary results from a second Phase 3 trial. According to the company, participants reported improvements in difficulties seeing the road because of oncoming headlights, as well as glare affecting vision during dawn and dusk.
The US Food and Drug Administration has already granted the eye drops Fast Track designation for the treatment of severe and chronic night-driving vision impairment. The designation is intended to help speed the development and review of medicines addressing serious conditions or unmet medical needs.
Despite the promising results, the eye drops must still complete the required regulatory process before receiving final approval and becoming widely available.
