Aerie Pharmaceuticals, Inc.’s (AERI - Free Report) shares gained 7.5% after the company announced successful 90-day primary efficacy data from the first phase III registration study, Mercury 1, on Roclatan.
Roclatan is a fixed-dose combination of Aerie’s lead candidate, Rhopressa (netarsudil ophthalmic solution) 0.02% and Pfizer Inc.’s (PFE - Free Report) Xalatan (latanoprost), the most widely prescribed prostaglandin analogue (PGA).
Roclatan (once daily) is being evaluated for its ability of lowering intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
Mercury 1 met the primary efficacy endpoint. Results demonstrated statistical superiority of Roclatan over each of the components in patients with maximum baseline IOPs ranging from over 20 mmHg (millimeters of mercury) to under 36 mmHg. In addition, the IOP-lowering effect of the candidate was 1 mmHg to 3 mmHg greater than monotherapy with either Xalatan or Rhopressa. There was neither any drug-related serious adverse event nor any evidence of treatment-related systemic effect.
Further details from the study are expected to be presented on the company’s ‘Investor Day’, which is scheduled for Oct 5, 2016. Aerie will also provide general business updates at the event.
We remind investors that in Mar 2016, Aerie had initiated the second phase III registration study, Mercury 2, on Roclatan. Top-line results from the study are expected in the first half of 2017.
Meanwhile, the company plans to initiate a third phase III study, Mercury 3, on Roclatan in the first half of 2017 to facilitate its regulatory approval and commercialization in Europe.
Based on the success of the Mercury 1 and Mercury 2 studies, the company plans to file a New Drug Application (NDA) for Roclatan around 2017 end.
Going forward, we expect investor attention on further updates by the company on Roclatan. Investors are also expected to focus on the company’s lead candidate, Rhopressa, which is currently under review in the U.S. Rhopressa is a once-daily eye drop designed to lower IOP in patients with glaucoma or ocular hypertension.
The company's shares were up significantly in Thursday’s pre-market trading session.
Aerie is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Anika Therapeutics, Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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