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Aerie (AERI) Starts Phase II Study on Eye Candidate in Japan

Zacks Equity Research

Aerie Pharmaceuticals, Inc. AERI announced that it has initiated the dosing in a phase II study on netarsudil ophthalmic solution in Japan for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

The study was designed to meet the requirements of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for supporting the eye care candidate’s potential regulatory filing in the East Asian island country.

Netarsudil ophthalmic solution 0.02% is approved for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. The drug is currently marketed under the trade name Rhopressa in the United States.

Shares of Aerie were almost 7.4% up following this news on Thursday. In fact, so far this year, the stock has surged 36.4%, outperforming the industry’s rally of 17.3%.

The above-mentioned multi-center, placebo-controlled phase II program will evaluate the IOP reducing effect and safety of three concentrations of netarsudil ophthalmic solution (0.01%, 0.02% and 0.04%) in Japan. The study will enroll approximately 208 patients in four treatment arms (0.01%, 0.02%, 0.04% and placebo), all administered once daily in the evening for a period of 28 days.

Aerie expects to complete enrollment in the study on netarsudil ophthalmic solution in Japan before this year-end and advance toward its phase III stage.

We would like to remind investors that in January 2019, Aerie announced positive top-line results from its pilot phase II evaluation of netarsudil ophthalmic solution in a Japanese-American population.

We would also like to put this forward that last week, Aerie received the FDA approval for Rocklatan to lower the elevated IOP in patients afflicted with open-angle glaucoma or ocular hypertension.

Rocklatan is a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s PFE Xalatan (latanoprost).

Zacks Rank & Other Stocks to Consider

Aerie currently carries a Zacks Rank #2 (Buy). Two other top-ranked stocks in the same sector are AIT Therapeutics, Inc. AITB and Assertio Therapeutics, Inc ASRT, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

AIT Therapeutics’ loss per share estimates have been narrowed 18.8% for 2019 and 11.8% for 2020 in the last 60 days. The stock has inched up 1.1% year to date.

Assertio Therapeutics’ earnings estimates have moved 6.8% north for 2019 and 8.2% for 2020 over the past 60 days. The stock has surged 33.8% so far this year.

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