Aerie Rockets as Eye Drug Wows in Key Phase III Study

Published: May 30, 2017

Aerie Rockets as Eye Drug Wows in Key Phase III Study May 25, 2017
By Mark Terry, Breaking News Staff

IRVINE, Calif. – Shares of Aerie Pharmaceuticals are soaring more than 35 percent this morning after the company announced Phase III data for its combination glaucoma drug, Roclatan, met efficacy endpoints.

California-based Aerie said in the Phase III Mercury 2 trial Roclatan demonstrated statistical superiority in lowering intraocular pressure over each of its component drugs – Rhopressa and market-leading prostaglandin analogue (PGA) latanoprost. The company said Roclatan lowered intraocular pressure 1 to 3 mmHg (millimeters of mercury) greater than the monotherapy drugs. According to Phase III data, Roclatan’s IOP lowering “exceeded that of latanoprost in a range of 1.5 to 2.4 mmHg for an average of 1.8 mmHg, and exceeded Rhopressa IOP lowering in a range of 2.2 to 3.3 mmHg for an average of 2.7 mmHg.” The Phase III study evaluated patients with maximum baseline intraocular pressures ranging from above 20 to below 36 mmHg. Roclatan reduced mean diurnal IOPs to 16 mmHg or lower in 56 percent of patients, a significantly higher percentage than observed in the two comparator arms, Aerie said.

Based on the results, Aerie said it plans to file for regulatory approval of Roclatan in the first half of 2018. Aerie’s Rhopressa is scheduled for review by the U.S. Food and Drug Administration in early 2018. Phase III data from Rhopressa showed the triple-action eye drop lowered intraocular pressure in patients with glaucoma and ocular hypertension. The company had hoped Rhopressa would be placed for review last year, but third-party manufacturing problems caused a delay.

Aerie has high hopes for Roclatan. The company said that clinical trial data, including from two Phase III trials, Mercury 1 and 2, could make Roclatan the first glaucoma product to lower IOP through all known mechanisms. “By covering the full spectrum of known IOP-lowering mechanisms, Roclatan has the potential to provide a greater IOP-lowering effect than any currently approved glaucoma product,” Aerie said.

Richard Lewis, Aerie’s chief medical officer, said Roclatan is distinguished by its ability to lower intraocular pressure to levels previously unseen with current glaucoma therapies.

“This product holds the promise of potentially becoming the first prostaglandin fixed-dose combination available in the United States,” Lewis said in a statement.

Glaucoma can cause blindness if it is left untreated. Glaucoma is not curable, and vision lost cannot be regained. However, some medications my halt disease progression.

“With this positive Mercury 2 data, we now have two successful pivotal trials for Roclatan. The topline efficacy results demonstrated in Mercury 2 are consistent with Mercury 1, confirming the potential for Roclatan to become the most efficacious IOP-lowering therapy to enter the market, if approved,” Vicente Anido, chairman and chief executive officer of Aerie, said in a statement.

The most common adverse event in the Phase III Mercury 2 trial was hyperemia, or eye redness, which was reported in nearly 55 percent of patients. Aerie said the issue was sporadic and was considered mild for the majority of patients. The company did say there was a 10 percent patient discontinuation for Roclatan, which the company also saw with Rhopressa.

Aerie said a third Phase III registration trial named Mercury 3 is expected to begin in Europe in mid-2017.

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