patients with moderate dry eye problems, who got either a plain liquid solution eye drop, or one of three different doses of the experimental compound from Resolvyx, called RX-10045. They took eye drops twice a day, for 28 days.
Patients who got high doses of the Resolvyx drug did better than those who got lower doses, the company said. Improvements were seen as quickly as one week, according to the main measurement of symptoms, which were reported in diaries kept by the patients. Resolvyx was also able to show that its drug was better than a placebo in a scientific measurement of how patients corneas appeared in a dry environment, although that difference didn’t reach the point of statistical significance. (One reason it may have fallen short, Nichols says: People in the placebo group also improved, because they had some liquid squirted into their eyes, like those in the drug group.)
“This is our first in man study, it’s the first study for this drug and the class,” Nichols says. “We saw a rapid and dose-dependent symptom control, which to our minds is unprecedented.”
Only one competing pharmaceutical is approved by the FDA—Allergan’s cyclosporine ophthalmic emulsion (Restasis), Nichols says. That drug takes as long as three months to control dry eye symptoms, according to published literature he cited. Another drug in development from Durham, NC-based Inspire Pharmaceuticals, diquafosol tetrasodiu (Prolacria), has shown promise on improving the scientific signs of the disease, but not as much improvement against the symptoms patients care about, Nichols says.
“We think we stack up fairly well,” he says.
Some big decisions about what to do next will now have to be made at Resolvyx, and someone new will be calling the shots. Paul Rubin stepped down recently as CEO, and the company is initiating a search for a new CEO, Nichols says. Whoever gets that job will be in an unusual position, at a venture-backed biotech company heading soon to the ultimate proving ground in biotech—Phase 3 clinical trials.
