Results

Aerie shares shoot up as investigators take another big step to an NDA with 2nd positive glaucoma PhIII

Aerie Pharmaceuticals is now two for two on its pivotal Phase III studies for Roclatan, a combo drug that combines the generic latanoprost to its in-house drug Rhopressa.

Investigators reported top line data today, saying that the combo beat each of the two drugs separately in lowering intraocular pressure, the key gauge for success here.

Once again, Aerie shares $AERI took off on the news, spiking more than 30% Thursday as investors pondered the implications. The biotech promised to file for an approval in the first half of 2018, provided an ongoing safety study ends successfully.

Aerie CEO Vicente Anido

The IOP-lowering effect of Roclatan, says Aerie, was 1 to 3 mmHg (millimeters of mercury) greater than monotherapy with either latanoprost or Rhopressa — which is up for an FDA review with a February 28, 2018 PDUFA date — in the study. The study evaluated patients with maximum baseline intraocular pressures ranging from above 20 to below 36 mmHg. The combo also reduced mean diurnal IOPs to 16 mmHg or lower for 56% of the patients taking it, better than both of the other drug arms. In the first Phase III the combo exceeded that of latanoprost by an average across the study duration of 1.9 mmHg and exceeded Rhopressa by 2.6 mmHg.”

Once again, though, the combo was also linked with a high rate of eye redness among patients, a trait also tied to Rhopressa. There was a 10% discontinuation rate in the study, and to be fair to company critics, this drug will get some very close scrutiny from regulators before it gets to the market.

A bullish Aerie CEO Vicente Anido has already touted Rhopressa as a likely blockbuster able to earn more than $1 billion a year, even though the biotech had to get the FDA’s permission to change the endpoint for its second late-stage study of Rhopressa in order to avoid back-to-back failures.

“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. Now that the efficacy results for both Mercury 1 and 2 have proven successful, and if the Mercury 1 12-month safety results are also successful, we expect to submit our Roclatan NDA (new drug application) in the first half of 2018,” said Aerie CEO Vicente Anido.


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RAPS Regulatory Convergence 2017