Aerie Pharmaceuticals Inc., which plans to seek a Japanese approval of its eye drop Rhopressa, said the medicine helped reduce fluid pressure in the eyes of Japanese-American patients with glaucoma studied in a mid-stage clinical trial.
The Durham, N.C.-based pharmaceutical company evaluated two doses of netarsudil ophthalmic solution, marketed as Rhopressa in the U.S., against placebo in a phase 2 trial comprising of 40 Japanese-American patients.
Japan's Pharmaceuticals and Medical Devices Agency had asked the company to evaluate the medicine to treat ocular hypertension in Japanese and Japanese-American patients with glaucoma. Ocular hypertension is a condition that occurs when the pressure inside the eye is more elevated than normal, which may lead to glaucoma — an eye disease that damages the optic nerve that transmits information from the eye to the brain. The condition can lead to vision loss and blindness.
After 28 days of treatment, Aerie's trial showed that the lowest dosage of the drug helped reduce fluid pressure in the eye by a range of 5 millimeters of mercury, or mmHg, to 5.3 mmHg in patients who had an average baseline intraocular pressure of 18.3 mmHg. The higher dosage arm of the trial showed an average reduction in pressure of 5.2 mmHg to 6.6 mmHg in patients with an average 20.2 mmHg of fluid pressure when they began treatment.
On the other hand, the placebo arm had an average reduction in pressure of 2 mmHg to 2.5 mmHg in patients who on average had 19.6 mmHg of fluid pressure when treatment began.
Rhopressa's safety profile was consistent with previous trials of the drug.
Aerie plans to begin a phase 2 trial of Rhopressa, which will include an even lower dose of the drug, in Japan in the first quarter.
The company filed an application with the U.S. Food and Drug Administration in May 2018 seeking approval of Roclatan, which is a fixed-dose combination of Rhopressa and a widely prescribed drug called prostaglandin analog latanoprost, which is sold by Pfizer Inc. under the brand name Xalatan.