Aerie Pharmaceuticals (AERI) Stock Surges After Eye Drug News

Shares of Aerie Pharmaceuticals (AERI) were trading up +13.42 or +63.51 percent to $34.55 per share in Thursday’s premarket. The stock rallied sharply after the company announced positive results for an eye drug yesterday after the market close.  Aerie Pharmaceuticals stock closed at $21.13, up +1.48 or +7.53 percent in Wednesday’s regular trading session.

Stock Analysis

Founded in 2005, Irvine, California based Aerie Pharmaceuticals Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of ophthalmic ailments.

Aerie’s two primary candidates, Rhopressa (netarsudil ophthalmic solution) and Roclatan (netarsudil/latanopros ophthalmic solution) are currently in clinical trials for lowering pressure in the eyes of glaucoma patients. The company went public on October 25th, 2013 at $10 per share.

Late yesterday, the company released the successful results of a study for Roclatan, one of its two primary drug candidates.
Aerie Pharmaceuticals (AERI) Stock Surges After Eye Drug News
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Aerie reported that Roclatan had achieved a 90 day Primary Efficacy Endpoint in its 12 month Phase 3 “Mercury 1” clinical trial for the fixed dose combination product. The endpoint was reached demonstrating statistical superiority over each component, including Aerie’s other product candidate, Rhopressa, and the market leader, prostaglandin analogue latanoprost (PGA).

Patients with glaucoma, which is a progressive and highly individualized ailment, suffer from elevated levels of intraocular pressure or IOP. This pressure is associated with damage to the optic nerve that results in the loss of vision and eventually potential blindness of the patient. Glaucoma patients generally have a wide range of IOP levels.

The Phase 3 Mercury 1 clinical trial showed that patients with maximum baseline intraocular pressures or IOPs, in the range of 20 to below 36 mmHg (millimeters of mercury) reacted favorably to the treatment. Patients in the control group were treated with eyedrops of Roclatan once a day.

Roclatan is a once a day eye drop that combines Rhopressa with latanoprost, the most prescribed treatment for glaucoma in the world. The IOP lowering effect of Roclatan was from one to three mmHg greater than monotherapy with either Rhopressa or latanoprost.

Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie stated in the company’s press release that, “We are very pleased by these RoclatanTM 90-day efficacy results from the Mercury 1 clinical trial. As expected, the topline efficacy demonstrated in this trial clearly reconfirms the potential for RoclatanTM to become the most efficacious IOP-lowering therapy to enter the market, if approved. If Mercury 1 and 2 are successful, we expect to file the NDA for RoclatanTM near year-end 2017.”

The first Phase 3 registration trial for the treatment is a 12 month safety trial conducted on 718 patients with a 90 day efficacy readout is designated Mercury 1. Mercury 2 is a 90 day efficacy trial which began in March of 2016 and a third Phase 3 trial, Mercury 3 is expected to begin in the first half of 2017 in Europe and is not necessarily for U.S. approval. Aerie shares will open at a new all time high this morning, surpassing its previous high of $34.15 made in April of 2015.

Other News About AERI

Aerie Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for Rhopressa™ (netarsudil ophthalmic solution) 0.02%

The NDA filing for Rhopressa is a major milestone for Aerie Pharmaceuticals.

Aerie (AERI) Q2 Loss Wider than Expected, Pipeline in Focus

Aerie posted a loss of -$0.87 in the second quarter versus an expected loss of -$0.75.

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Published on Sep 15, 2016
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2020. Content published with author's permission.

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