Aerie Pharmaceuticals, Inc. (AERI - Free Report) announced that the European Medicines Agency (EMA) has accepted for review its marketing authorization application (MAA) for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%.
The drug is currently marketed as Rocklatan in the United States for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Rocklatan is a once-daily, quadruple action, fixed-dose combination of Rhopressa and Pfizer’ (PFE - Free Report) Xalatan.
An opinion from the EMA’s Committee for Medicinal Products for Human Use on the MAA is expected in late 2020. Upon approval, Roclanda would be the first fixed-dose combination of its kind in Europe.
Meanwhile, Aerie expects to complete and analyze its Mercury 3 study in the second half of 2020. The study compares Roclanda to the leading fixed-dose combination product in Europe and is designed to support pricing and reimbursement activities in Europe but is not necessary for EMA approval.
A potential approval of Roclanda will strengthen Aerie’s portfolio as glaucoma is one of the largest segments in the global ophthalmic market. Approval in additional geographies will boost sales of the company. Lead drug Rhopressa is already approved for lowering elevated IOP in patients with open-angle glaucoma or ocular hypertension. Rhopressa is a once-daily formulation for IOP in patients suffering from open-angle glaucoma and ocular hypertension.
Aerie’s stock has plunged 37% in the year so far against the industry’s growth of 9.6%.
Volumes of drugs haven’t picked up as per Aerie’s expectations. Also, competition is stiff from the likes of Allergan’s (AGN - Free Report) Lumigan and Bausch Health's (BHC - Free Report) Vyzulta, among others.
Aerie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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