A new type of eye drop could help people who struggle to see clearly while driving at night.
Opus Genetics reported encouraging results from late-stage studies of phentolamine ophthalmic solution 0.75%. The treatment improved several measures of vision in dim and dark conditions.
The company is developing the drops for people with chronic night-driving problems linked to reduced vision in low-light conditions. The U.S. Food and Drug Administration has granted the program Fast Track designation.
Eye Drops Improve Low-Light Vision
In one Phase 3 study, researchers evaluated 145 people who experienced reduced vision in dim or dark settings.
Many participants also reported glare, halos and starbursts. These symptoms can make night driving especially difficult.
Participants received either the phentolamine drops or a placebo. They used the treatment daily for either eight or 15 days.
After eight days, 13% of people who received the drug gained at least three lines on a low-light eye chart. That equals an improvement of 15 letters.
By comparison, only 3% of the placebo group achieved the same level of improvement.
The difference became larger after 15 days. At that point, 21% of patients receiving the drops achieved the 15-letter improvement. The placebo group remained at 3%.
Less Trouble With Glare and Headlights
The researchers also asked participants to rate their overall night-vision difficulties.
Patients who received phentolamine reported a decline in the severity of their symptoms. Their average score fell from 4.3 after eight days to 3.3 after 15 days.
The placebo group reported scores of 4.6 and 4.3 at the same points.
By day 15, people using the eye drops also reported less difficulty with glare, halos and starbursts.
Those improvements could be important for people who struggle with oncoming headlights or other bright lights while driving after dark.
How the Eye Drops Work
Phentolamine works on a muscle in the iris, the colored part of the eye.
The treatment causes the pupil to constrict moderately and remain smaller for an extended period. Researchers reported that the effect can last for at least 20 hours.
The company is studying the treatment specifically in people with visual problems under mesopic, or low-light, conditions.
Some patients in the trials developed their symptoms after procedures that reshape the cornea. LASIK and similar procedures can sometimes be followed by visual disturbances, according to the researchers.
Second Phase 3 Study Adds More Evidence
Opus Genetics has also reported encouraging initial results from another Phase 3 study.
According to the company, patients reported functional improvements when trying to see the road because of oncoming headlights. They also reported less difficulty with glare while driving around dawn or dusk.
Dr. Jay Pepose, the company’s chief medical adviser, said the results showed improvements in real-world visual difficulties reported by participants.
Earlier Phase 3 results also showed that the treatment met its primary endpoint. In the LYNX-2 study, 17.3% of participants receiving phentolamine achieved at least a 15-letter improvement after 15 days, compared with 9.2% of those receiving placebo.
FDA Review Still Ahead
The eye drops are not yet approved in the United States for chronic night-driving impairment.
The FDA has granted Fast Track designation to the program. That designation can help speed development and regulatory review for treatments aimed at serious conditions or unmet medical needs.
Phentolamine ophthalmic solution is already FDA-approved under the brand name RYZUMVI for pharmacologically induced pupil dilation. However, the company is pursuing additional uses for the medicine.
For now, the latest clinical findings offer encouraging evidence for people who find night driving difficult. Further regulatory decisions will determine whether the treatment becomes available specifically for chronic night-vision problems.
