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Company Spotlight: Aerie Pharmaceuticals


Shares of Aerie Pharmaceuticals Inc. (AERI) are up nearly 44% year-to-date, well ahead of the iShares Nasdaq Biotechnology Index (ETF) (IBB), which has returned only 28% during the same period.

Aerie is a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of patients with glaucoma and other eye diseases.
The Company's most-advanced product candidate is Rhopressa 0.02%, a once-daily eye drop, for the treatment of patients with open-angle glaucoma or ocular hypertension.

Open-angle glaucoma, which is the most common form of glaucoma, is caused by the slow clogging of trabecular meshwork - the drainage canal of the eye, resulting in increased eye pressure, and is characterized by a wide and open angle between the iris and cornea.

In clinical studies, Rhopressa, whose active ingredient is netarsudil, has demonstrated non-inferiority to Timolol, the most widely used comparator, in lowering intraocular pressure (IOP) in patients with glaucoma.

The Company initially submitted the NDA for Rhopressa to the FDA in September 2016. But it was withdrawn the following month due to a third party manufacturing facility in Tampa, Florida, not being ready for pre-approval inspection by the FDA at that time.

The Rhopressa NDA was re-submitted to the FDA in January of this year after the Tampa, Florida facility became ready for pre-approval inspection by the regulatory agency.

The FDA's final decision on Rhopressa 0.02% is expected to be announced by February 28, 2018. Before the regulatory agency announces its final decision, Rhopressa NDA is all set to be reviewed by an outside panel of FDA experts on October 13, 2017.

Next in the line-up is Roclatan, a fixed dose combination of Rhopressa and Latanoprost, for treatment of elevated IOP.

The Company has successfully completed two U.S. phase III studies with Rhopressa, and NDA preparation is underway. The NDA for Rhopressa is expected to be filed with the FDA in the first half of 2018.

The European phase III clinical trial of Roclatan, dubbed Mercury 3, was initiated as recently as last month.

The Mercury 3 trial is designed to enroll about 500 patients, and topline 90-day efficacy data from the study is expected to be read out by early 2019.

Also in the pipeline is AR-13154 for wet AMD for which the company is continuing its IND-enabling activities.

Recent Event:

On October 5, 2017, the Company acquired from Envisia Therapeutics Inc., the rights to use PRINT technology in ophthalmology and certain other assets and intellectual property rights relating to ENV1105.

ENV1105 is Envisia's pre-clinical dexamethasone steroid product candidate for the treatment of diabetic macular edema (DME), which also utilizes the PRINT technology.

Aerie intends to initially focus in using PRINT to manufacture injectable implants containing AR-13154.

Key Numbers: (at June 30, 2017)

-- Cash & investments: $308 million
-- Total debt: $123.69 million
-- Shares Outstanding: 36.34 million
-- Float: 24.44 million

AERI, which has traded in a range of $32.05 to $61.30 over the last 1 year, closed Thursday's trading at $54.50, up 0.28%.

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