Aerie Looks to Japanese Market for Eye Drug, Opens Tokyo Office

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Aerie Pharmaceuticals, an ophthalmic pharmaceutical company based in Durham, has reported positive results from a pilot Phase 2 study of an eye drop intended to reduce high intraocular pressure (IOP), a cause of glaucoma.

The study, involving 40 Japanese-American patients, was conducted to support the potential regulatory submission of netarsudil ophthalmic solution in Japan. Aerie said it expected to initiate a similar Phase 2 clinical trial in that country in the first quarter of 2019. 

The drug is known as Rhopressa in the United States, where it is marketed as a once-daily eyedrop for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. The drug, Aerie’s first commercial product, won approval from the U.S. Food and Drug Administration in December 2017 and was launched in April 2018.

Both of the trial’s study arms showed higher levels of IOP reduction compared to placebo at day 28, and the safety findings were consistent with previous netarsudil trials, the company reported. The study design followed the requirements of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). 

“These pilot study results, while representing a relatively low number of subjects, may hold great promise for the Japanese glaucoma market,” said Vicente Anido Jr., Ph.D., chairman and chief executive officer of Aerie.

Netarsudi’s IOP-reducing performance in the pilot study compares favorably to that of a similar but twice-daily drug currently marketed in Japan, Anido said.

The Japanese glaucoma market, estimated at about $1 billion annually, is one of the world’s largest.

“We believe there continues to be substantial unmet need in this very important market for Aerie,” Anido said. 

The company announced it has opened a Japan branch office in Tokyo and hired two industry veterans to staff it. Yasuhide Fukushima, formerly with Alcon Japan, will be head of strategy and professional affairs, and Kenji Aso, M.D., Ph.D., formerly with Japan Bayer Yakuhin, will be head of clinical.

Aerie is an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma, retina diseases and other diseases of the eye. 

The company, a spinout of Duke University, has about 350 employees at its sites in Durham, Irvine, Calif., Bedminster, N.J., and in Ireland, where it has an office in Dublin and a manufacturing plant in Athlone that is scheduled to come online in 2020.

The Durham headquarters has about 60 employees and is adding more.

Aerie’s stock shares are traded on the NASDAQ Global Market stock exchange under the symbol AERI.

Barry Teater, NCBiotech Writer
Fri, 01/04/2019 - 16:22