Aerie Pharmaceuticals, Inc. (AERI - Free Report) announced the initiation of phase III study -Mercury 3 in Europe for its pipeline candidate Roclatan 0.02%/0.005%. Roclatan is a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan, iis being evaluated to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
Aerie’s stock has surged 51.8% year to date, compared with the industry’s gain of 10.2%.
The company is conducting Mercury 3 to facilitate regulatory filings and commercialization in Europe and is not necessary for approval in the United States. The company expects 500 patients to enroll in the study. The study will be a two-arm, six-month safety trial that and it will provide a 90-day interim efficacy readout. The study will compare Roclatan for non-inferiority to prescribed fixed dose combination that is Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan (AGN - Free Report) in Europe. The study will be conducted mainly in the United Kingdom, France, Germany, Italy, Spain, and Belgium. The topline 90 day efficacy data is expected by early 2019.
We remind investors that, the company reported positive 12 month safety results in July 2017 from Mercury 1 phase III study and positive top line 90-day efficacy and safety data from the second phase III study, Mercury 2 in May 2017. Aerie expects to submit a new drug appication (NDA) for Roclatan to FDA in the first half of 2018.
Apart from Roclatan, Aerie is also evaluating Rhopressa, which is designed to lower IOP in patients through novel mechanisms of action (MOAs) to treat patients with glaucoma or ocular hypertension. On Feb 28, the company resubmitted its NDA for Rhopressa and expects a standard review period of 12 months. The company also expects to start a clinical study for Rhopressa later in 2017 to address the Japanese market.
Aerie Pharmaceuticals, Inc. Price
Zacks Rank & Stocks to Consider
Aerie currently carries a Zacks Rank #3 (Hold). A better-ranked stock in health care sector includes Alexion Pharmaceuticals, Inc. (ALXN - Free Report) sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion Pharmaceuticals’ earnings per share estimates have moved up from $5.32 to $5.61 for 2017 and from $6.53 to $6.92 for 2018 over the last 60 days. The company delivered positive earnings surprises in all the trailing four quarters, with an average beat of 11.12%. The share price of the company has increased 18.7% year to date.
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