Aerie Pharmaceuticals, Inc. AERI announced positive top-line results from its pilot phase II study of netarsudil ophthalmic solution in a Japanese-American population. Netarsudil ophthalmic solution 0.02% is currently marketed by the name Rhopressa in the United States. The study was designed to meet the requirements of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to support the potential regulatory submission of netarsudil ophthalmic solution in Japan.
The primary objective of the study was to evaluate the ocular hypotensive activity of two different dose concentrations of netarsudil ophthalmic solution (0.02% and 0.04%) relative to placebo over a 28-day period, for a total of three arms all dosed. The primary objective also included evaluating the ocular and systemic safety of netarsudil ophthalmic solution relative to placebo over the 28-day period.
In the study, both netarsudil arms (0.02% and 0.04%) showed higher levels of intraocular pressure (IOP) reduction as compared to placebo to a statistically significant degree at Day 28. The safety findings were consistent with previous netarsudil studies.
This pilot study was initially designed as a larger phase II trial to be conducted in the United States, enrolling Japanese subjects and Japanese-American subjects that are within second generation. However, due to lesser number of qualified subjects in the United States, the enrollment of this study was limited to approximately 40 subjects across three study arms.
Aerie expects to initiate a phase II study in Japan in the first quarter of 2019, as agreed with the PMDA, with the addition of a 0.01% concentration of netarsudil.
Shares of the company decreased 34.9% compared with the industry’s decline of 18.2%.
Glaucoma is one of the largest segments in the global ophthalmic market. The Japanese glaucoma market, valued at approximately $1 billion annually, is one of the largest in the world.
Aerie is also evaluating Rocklatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer's PFE Xalatan (latanoprost). Rocklatan is a once-daily eye drop designed to reduce intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Aerie’s New Drug Application (NDA) for Rocklatan 0.02%/0.005% was submitted to the FDA in May 2018. The action date for the completion of the FDA’s review of the NDA is set for Mar 14, 2019.
Along with the release, the company also announced the opening of its Japan branch office in Tokyo, and the addition of two well-respected industry leaders to its Tokyo team.
Aerie Pharmaceuticals, Inc. Price
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Zacks Rank & Stocks to Consider
Aerie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth considering are Myriad Genetics, Inc. MYGN and Editas Medicine, Inc. EDIT. While Myriad sports a Zacks Rank #1 (Strong Buy), Editas carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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