WASHINGTON: A new eye drop developed by U.S.-based Opus Genetics has shown encouraging results in late-stage clinical trials for people who experience difficulty seeing in low-light conditions and are troubled by glare, halos and starburst-like rays while driving at night.
According to the reported trial findings, the eye drops could offer a potential new treatment option for people experiencing night-vision problems, including some patients whose symptoms developed after corneal procedures such as LASIK.
In the first Phase 3 clinical trial, 145 participants with difficulties seeing in dim light or darkness, along with glare, halos and starbursts, were enrolled.
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 eye drops showed an improvement of at least three lines, or 15 letters, on an eye chart, compared with 3% in the placebo group. By day 15, the improvement rate among those receiving the drug increased to 21%, while the placebo group remained at 3%.
Participants also rated the severity of their night-vision difficulties on a scale of one to seven, with seven representing the greatest severity.
Among those receiving the eye drops, the average score 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.
The study also reported a notable reduction in problems associated with glare, halos and starburst-like rays among participants using phentolamine by the 15th day.
How Do the Eye Drops Work?
Researchers say the eye drops act on a muscle in the iris, causing the pupil to contract in a controlled and sustained manner. According to the reported findings, the effect may last for at least 20 hours.
Some participants in the study experienced night-vision problems following procedures that alter the structure of the cornea, including LASIK surgery, which is commonly used to correct vision problems such as nearsightedness, farsightedness and astigmatism.
Opus Genetics has also reported encouraging initial results from a second Phase 3 trial. According to the company, participants reported improvements in difficulties seeing the road because of approaching headlights, as well as glare-related vision problems during dawn and dusk.
The U.S. Food and Drug Administration (FDA) has already granted the eye drops Fast Track designation for the treatment of severe and chronic night-driving vision impairment.
Fast Track designation is intended for drugs that may address serious conditions or important unmet medical needs and can help facilitate development and regulatory review.
However, despite the encouraging clinical findings, the eye drops still need to complete the applicable regulatory process before final approval and widespread use.