Aerie Pharmaceuticals, Inc. AERI announced that it has completed enrollment in its double-masked, multi-center, placebo-controlled, parallel group phase II study on Rhopressa (netarsudil ophthalmic solution 0.02%) in Japan.
The study completed enrollment months earlier than previously anticipated.
The first patient was dosed late March 2019. Subsequently, a total of 215 patients were successfully randomized across four treatment arms — netarsudil ophthalmic solution 0.01%, netarsudil ophthalmic solution 0.02%, netarsudil ophthalmic solution 0.04% and placebo — all administered once daily in the evening for three months.
The study was designed in accordance with the requirements of Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) as a precursor to phase III studies to support potential regulatory submission of netarsudil ophthalmic solution in Japan.
The design of this trial is consistent with that of a recent phase II pilot study that Aerie conducted in a Japanese-American population in the United States, with the addition of the netarsudil ophthalmic solution 0.01% treatment arm to confirm the concentration of netarsudil most suitable for Japanese patients.
We note that the drug is already approved in the United States for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The uptake of Aerie’s lead drug, Rhopressa, has been strong so far. The drug continues to gain traction with an increase in covered lives under various medicare plans.
The objective of the above-mentioned study is to evaluate the IOP-reducing effect and safety of the three concentrations of netarsudil ophthalmic solution over a 28-day period.
Approval in additional countries should further boost sales.
Aerie’s stock has lost 29.1% in the year so far against the industry’s growth of 8.6%.
Meanwhile, the FDA recently approved Aerie’s second drug, Rocklatan 0.02%/0.005%, to reduce 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 (netarsudil) and Pfizer’s PFE Xalatan (latanoprost).
The approval has boosted growth prospects of the company despite stiff competition from the likes of Bausch Health's BHC Vyzulta, among others.
Zacks Rank & A Key Pick
Aerie currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is Novartis Ag NVS, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Novartis’ earnings per share estimates increased from $4.98 to $5.01 for 2019 and from $5.48 to $5.56 for 2020 over the past 60 days.
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