Once-daily eye drop for glaucoma

May 8, 2019 0 By FM

The US FDA has okayed new drug netarsudil 0.02% and latanoprost 0.005% ophthalmic solution (Rocklatan) for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The once-daily eye drop that is a fixed-dose combination of latanoprost, the most widely-prescribed prostaglandin analogue (PGA), and netarsudil, the active ingredient in netarsudil ophthalmic solution 0.02%, a first-in-class Rho kinase (ROCK) inhibitor specifically designed to target the trabecular meshwork.

The diseased trabecular meshwork is considered to be the main cause of elevated IOP in open-angle glaucoma and ocular hypertension.

Aerie, the maker of the drug, plans to launch the drug in the US in the second quarter of 019.

The FDA approval of is based on data from two phase 3 registration trials, MERCURY 1 and MERCURY 2. In these studies, the drug achieved its primary 90-day efficacy endpoint as well as positive 12-month safety and efficacy results, demonstrating statistically superior IOP reduction over latanoprost and netarsudil at every measured time point.