Aerie wins FDA nod for second glaucoma drug

Aerie Pharmaceuticals (NSDQ:AERI) said this week that the FDA approved the company’s once-daily eye drop Rocklatan for the treatment of elevated intraocular pressure in people with open-angle glaucoma or ocular hypertension.

The Durham, N.C.-based company’s product is a fixed-dose combination of latanoprost and netarsudil – the active ingredient in Aerie’s first drug, Rhopressa.

After winning an early FDA approval for Rhopressa in Dec. of 2017, Aerie launched the drug in the U.S. in April last year. The company reported that it’s slated to launch Rocklatan in the second quarter of this year.

In Phase III registration trials, Rocklatan had statistically significant IOP reduction over latanoprost and netarsudil at every measured time point, according to Aerie. The company touted that more than 60% of people using Rocklatan in the clinical studies experienced an IOP reduction of at least 30%.

“We are in the unique position of receiving FDA approval on a second glaucoma treatment less than a year from the U.S. launch of Rhopressa,” chairman & CEO Vicente Anido, Jr. said in prepared remarks.

“Together, Rocklatan and Rhopressa give us a broad therapeutic franchise, based on our ROCK inhibitor netarsudil, that addresses many of the needs of clinicians and patients in a wide variety of treatment settings. Our existing salesforce, which has been calling on U.S. eye-care professionals since last May, is very well positioned to introduce Rocklatan to these doctors and help them understand the clinical utility of both products in the care of their patients with glaucoma. We have also been working diligently on securing favorable reimbursement for our products, with Rhopressa now enjoying broad commercial and Medicare Part D coverage, and Rocklatan already under review by major payers,” he added.

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