Aerie Pharmaceuticals, Inc. AERI announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending a marketing approval for Rhokiinsa (netarsudil ophthalmic solution 0.02%) to reduce elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension.
Rhokiinsa is already marketed as Rhopressa in the United States for the same indication.
If approved, Rhokiinsa will be available in all EU member states along with Iceland, Norway and Liechtenstein. A final decision is expected within the next two months.
Shares of Aerie have plunged 35.4% so far this year against the industry’s increase of 7%.
We remind investors that in December 2017, Aerie's lead drug Rhopressa was approved by the FDA for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. The drug was launched toward the end of April 2018. Aerie's second drug Rocklatan, a once-daily, quadruple-action, fixed-dose combination of Rhopressa and Pfizer's PFE Xalatan, was approved by the FDA in March 2019 to lower the elevated IOP in patients with open-angle glaucoma or ocular hypertension.
Also, Aerie plans to submit an Marketing Authorisation Application (MAA) for Rocklatan in Europe on the potential approval of Rhokiinsa in the region. Rocklatan will be marketed under the trade name of Roclanda in Europe. A phase III Mercury 3 study on Rocklatan continues to progress in Europe.
Meanwhile, in July 2019, Aerie completed enrollment in the parallel group phase II study on Rhopressa 0.02% in Japan. The study closed the recruitment ahead of schedule with data expected by this year-end.
The uptake of Rhopressa has been strong so far. The drug continues to gain traction with an increase in covered lives under various medicare plans. Approval in additional countries should further boost its sales. However, Rhopressa is likely to face a tough competition from Bausch Health's BHC Vyzulta, which is also approved for the treatment of patients suffering open-angle glaucoma or ocular hypertension.
Zacks Rank & Stock to Consider
Aerie currently carries a Zacks Rank #4 (Sell).
A better-ranked stock in the same sector is FibroGen, Inc FGEN, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
FibroGen’s loss per share estimates have been narrowed 66.1% for 2019 and 40.6% for 2020 over the past 60 days.
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