Shares of Aeri Pharmaceuticals Inc. (NASDAQ: AERI) skyrocketed early Thursday after the company issued positive results on its intraocular pressure (IOP) treatment in patients with glaucoma.
Keep in mind that this company focuses primarily on the treatment of glaucoma and other diseases of the eye, so a win in this study is truly monumental for Aeri and its shareholders going forward. The implications are not just for Roclatan but across its entire treatment platform, as most of its candidates have a similar focus and indication.
As for the results, the company released the successful 90-day primary efficacy results of its 12-month Phase 3 “Mercury 1” clinical trial for its fixed-dose combination product candidate, Roclatan. The study achieved its primary efficacy endpoint demonstrating statistical superiority over each of its components, including Aerie product candidate Rhopressa (netarsudil ophthalmic solution) 0.02%, and market leading prostaglandin analogue (PGA) latanoprost, all of which were dosed once daily in the evening.
The IOP-lowering effect of Roclatan was 1 to 3 mmHg greater than monotherapy with either latanoprost or Rhopressa throughout the duration of the study.
The most common Roclatan adverse event was hyperemia, or eye redness, which was reported in about 50% of patients, or 30% above baseline, and was scored as mild for the large majority of these patients. There were no drug-related serious adverse events for any of the comparators in the trial.
Vicente Anido, Jr., Ph.D., chairman and CEO at Aerie, commented:
We are very pleased by these Roclatan 90-day efficacy results from the Mercury 1 clinical trial. As expected, the topline efficacy demonstrated in this trial clearly reconfirms the potential for Roclatan 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 Roclatan near year-end 2017.
Excluding Thursday’s move, Aeri Pharma has underperformed the broad markets, with the stock down 13% year to date. Over the past 52 weeks, the stock is up nearly 18%.
Shares of Aeri Pharma closed Wednesday up 7.5% at $21.13, with a consensus analyst price target of $46.13 and a 52-week trading range of $10.82 to $33.25. Following the release of the results, the stock was up about 66.5% at $35.19 in early trading indications Thursday.