Aerie Pharmaceuticals Inc (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced the completion of patient enrollment in Rocket 4, the Company’s Phase 3 clinical trial for RhopressaTM (netarsudil ophthalmic solution) 0.02% intended to satisfy filing requirements in Europe. RhopressaTM is a novel once-daily eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. Rocket 4 achieved total enrollment of approximately 700 patients and is a two-arm 90-day efficacy study, comparing once-daily RhopressaTM for non-inferiority to twice-daily timolol. The range for the primary endpoint mirrors Aerie’s successful Rocket 2 trial, including patients with baseline IOPs ranging from above 20 mmHg (millimeters of mercury) to below 25 mmHg. Rocket 4 also includes a secondary endpoint range of baseline IOPs from above 20 mmHg to below 27 mmHg, and additionally a secondary endpoint timeframe of six months.
To ensure a proper cohort of patients in the study for primary and secondary endpoint purposes, Rocket 4 includes enrollment of patients with baseline IOPs up to 30 mmHg. Rocket 4 is designed to provide six-month safety data for a minimum of 300 patients on RhopressaTM to support expected future regulatory filing requirements in Europe. It is not required for the RhopressaTM NDA filing, which is on plan to be filed in the third-quarter of 2016. The 90-day interim topline efficacy results of this trial are expected to be reported in the fourth quarter of 2016, on schedule with the previously reported timeline.
“Rocket 4, while not needed for our RhopressaTM NDA filing expected to be submitted next quarter, is designed to provide adequate RhopressaTM safety data for our future expected filings with the European regulatory authorities. Europe represents a very large glaucoma market, and we expect to file for European approval of RhopressaTM in the second half of 2017,” saidVicente Anido, Jr., Ph.D., Chief Executive Officer and Chairman at Aerie. (Original Source)
Shares of Aerie Pharmaceuticals closed yesterday at $18.4, up $0.05 or 0.27%. AERI has a 1-year high of $33.25 and a 1-year low of $10.82. The stock’s 50-day moving average is $16.31 and its 200-day moving average is $17.29.
On the ratings front, Aerie has been the subject of a number of recent research reports. In a report issued on June 2, Cantor Fitzgerald analyst Elemer Piros initiated coverage with a Buy rating on AERI and a price target of $44, which represents a potential upside of 139.1% from where the stock is currently trading. Separately, on May 16, Brean Murray Carret’s Difei Yang reiterated a Buy rating on the stock and has a price target of $48.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Elemer Piros and Difei Yang have a total average return of -22.1% and -11.4% respectively. Piros has a success rate of 28% and is ranked #3820 out of 3971 analysts, while Yang has a success rate of 35% and is ranked #3838.
The street is mostly Bullish on AERI stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating .
Aerie Pharmaceuticals, Inc. is a clinical stage pharmaceutical company focused on the discovery, development and commercialization of therapies for the treatment of patients with glaucoma and other diseases of the eye. The company’s product candidates are tiple action Rhopressa and quadruple action Roclatan.