SoCal's Aerie Stock Soars Over the Rainbow on Positive Phase III Eye Drug Data

SoCal's Aerie Stock Soars Over the Rainbow on Positive Phase III Eye Drug Data September 15, 2016
By Mark Terry, BioSpace.com Breaking News Staff

Irvine, California-based Aerie Pharmaceuticals leapt over 55 percent on news that its Roclatan to treat glaucoma had positive data from its Phase III clinical trial.

Roclatan is a once-daily eye drop. It combines Rhopressa, another Aerie product, with latanoprost, the most widely prescribed glaucoma drug in the world. Rhopressa (netasudil ophthalmic solution) targets the trabecular meshwork, which is the primary drainage system of the eye, and the damaged tissue primarily responsible for glaucoma.

Glaucoma is a progressive and individualized disease of the eye, in which elevated levels of intraocular pressure cause damage to the optic nerves. This typically causes irreversible loss of vision and can lead to blindness.

Aerie believes that if Roclatan is approved, it would be the first treatment for intraocular pressure (IOP) that treats glaucoma through all known mechanisms. The primary endpoint achieved in the study was statistical superiority over each of its components, including its own Rhopressa, as well as latanoprost.

“We are very pleased by these Roclatan 90-day efficacy results from the Mercury 1 clinical trial,” said Vicente Anido, Aerie’s chairman and chief executive officer, in a statement. “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 expected to file the NDA for Roclatan near year-end 2017.”

Aerie Pharmaceuticals stock jumped from $20.10 on September 9 to a current price of $32.68. Shares traded on November 25, 2015 for $27.63 and a low of $11.09 on March 17, 2016.

Serge Belanger, an analyst with Needham & Co., wrote in a research note today that the news was a “major ‘home run’ for Roclatan.” He also raised Aerie’s price target from $45 to $52. Brokerage firm Stifel Nicolaus also raised its price target from $40 to $50.

“Once-daily Roclatan has shown a degree of IOP lowering in Mercury 1 that is quite impressive, especially when considering its ability to bring patient pressures down to levels as low as 8 to 14 mmHg,” Richard Lewis, Aerie’s chief medical officer said in a statement. “The safety profile of Roclatan observed thus far in Mercury 1 points to a safe and tolerable product.”

Aerie submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Rhopressa on September 6. It indicated it expected a standard 12-month review process.

In addition to Rhopressa and Roclatan, Aerie holds a library of Rho kinase (ROCK) inhibitors of over 3,000 compounds. They are being evaluated to determine if they can protect the optic nerves from damage, as ROCK inhibitors are neuroprotective. It also is evaluating compounds for age-related macular degeneration, as well as potential disease process related to inflammation, fibrosis, and angiogenesis.

Aerie is evaluating AR-13165 in wet age-related macular degeneration.

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