Experimental Eye Drops Improve Night Vision; US Cancer Centers Face Drug Shortages

Eye Drops Show Promise for Night Vision Impairment

An experimental eye drop developed by Opus Genetics has significantly improved night vision in patients who struggle to drive in the dark, according to data from two late-stage clinical trials.

In the first trial, 145 patients with impaired visual acuity in dim or dark conditions—and symptoms such as glare, halos, and starbursts—were given either the Opus drops containing 0.75% phentolamine ophthalmic solution or a placebo daily for eight or 15 days.

After eight days, 13% of those receiving the phentolamine drops gained at least three lines (15 letters) on eye charts, compared with 3% in the placebo group. By day 15, 21% of the treatment group showed such improvement, while the placebo group remained at 3%.

Patients also rated their overall night vision problems on a scale of 1 to 7, with 7 being most severe. Those on the drug reported scores of 4.3 by day 8 and 3.3 by day 15, a statistically significant improvement over the placebo group's 4.6 and 4.3, respectively. By day 15, the treatment group also reported significantly less trouble with glare, halos, and starbursts.

The drops work by acting on a muscle in the iris to produce moderate, sustained pupil constriction lasting at least 20 hours, researchers reported in The American Journal of Ophthalmology. Many patients experienced symptoms as after-effects of corneal reshaping procedures such as LASIK surgery.

Opus Genetics also announced encouraging initial results from a second Phase III trial. Dr. Jay Pepose, the company's chief medical adviser, said in a statement that patients reported functional improvements in difficulty seeing the road due to oncoming headlights and glare when driving at dawn or dusk.

The U.S. Food and Drug Administration has granted Fast Track designation for the drops as a treatment for significant chronic night driving impairment. This designation, reserved for drugs addressing serious conditions or unmet medical needs, can expedite the approval process.

US Cancer Centers Report Widespread Drug Shortages

A survey of leading U.S. cancer centers released on Thursday highlights the extent to which they are struggling to obtain medications for patients, with nearly all reporting shortages of critical generic therapies.

In late August, the National Comprehensive Cancer Network (NCCN) surveyed pharmacy directors and other clinical and administrative leaders at its 34 member institutions. Among the 31 centers that responded, all reported a shortage of at least one anti-cancer agent, and more than 20% said they currently face shortages of five or more different medications.

A shortage of ifosfamide, a generic chemotherapy used for bladder, ovarian, testicular, uterine, soft tissue sarcoma, osteosarcoma, and blood cancers, was reported by 94% of respondents. Additionally, 71% reported a shortage of carboplatin and 16% were short on cisplatin—important chemotherapies used as the backbone of regimens for numerous tumor types. The immunotherapy Bacillus Calmette-Guérin for bladder cancer was also in short supply for more than half of the respondents.

When treatment plans had to be modified due to these shortages, 90% of centers noted a need for repeat prior authorization by insurance companies, significantly increasing workload per patient and potentially delaying care continuity.

"Nearly every pharmacy director who responded to our survey would like to see economic incentives put in place to encourage high-quality manufacturing for generic cancer medications," said Alyssa Schatz, NCCN's vice president of policy & advocacy, in a statement. "That is something that advocates have been requesting for years. As one respondent noted: 'many oncology generics are clinically indispensable but economically unattractive. Without correcting that economic imbalance, shortages are likely to recur.'"