Durham, N.C.-based Aerie Pharmaceuticals Inc. submitted a new drug application to the U.S. Food and Drug Administration for its Roclatan eye drop to reduce fluid pressure in the eye in patients with glaucoma or ocular hypertension.
Ocular hypertension occurs when the pressure inside the eye is more elevated than normal. A person with ocular hypertension is at heightened risk to develop glaucoma — an eye disease that damages the optic nerve, which transmits information from the eye to the brain, and could lead to vision loss and blindness.
Roclatan, also known as netarsudil/latanoprost ophthalmic solution, is a fixed-dose combination of Aerie's Rhopressa, which is available in the U.S., and the widely prescribed prostaglandin analog latanoprost, which is sold by Pfizer Inc. under the brand name Xalatan.
The submission is based on the results of two phase 3 studies in which Roclatan achieved its primary efficacy goals. A third phase 3 trial for Roclatan is ongoing in Europe but is not required for U.S. approval.
The FDA's review period is expected to last 10 months, instead of 12 months, since Roclatan is a fixed-dose combination of two previously approved drugs in the U.S.