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FDA Approves Glaucoma Drug Rhopressa Ahead of Schedule
The FDA has approved netarsudil ophthalmic solution, 0.02% (Rhopressa, Aerie Pharmaceuticals, Inc.) for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The FDA approval decision came two months ahead of the scheduled Prescription Drug User Fee Act goal date of February 28, 2018.
Netarsudil ophthalmic solution is a novel, once-daily eye drop for the lowering of elevated IOP. It is believed to reduce IOP by increasing the outflow of aqueous humor (the fluid inside the eye) through the trabecular meshwork, the main fluid drain of the eye.
This agent is Aerie's first FDA-approved product. The company is also developing Roclatan (netarsudil 0.02%/latanoprost 0.005% ophthalmic solution), a fixed-dose combination of Rhopressa and the widely prescribed prostaglandin analogue latanoprost.
Roclatan achieved its primary efficacy endpoint in two phase 3 registration trials (Mercury 1 and Mercury 2) and also achieved successful 12-month safety and efficacy results in Mercury 1. The Roclatan new drug application submission is expected to take place in the second quarter of 2018, according to Aerie.
Source: Aerie Pharmaceuticals, Inc.; December 18, 2017.