(Adds details on launch plan, quote from CEO)
Dec 18 (Reuters) - Aerie Pharmaceuticals Inc said on Monday the U.S. Food and Drug Administration (FDA) approved its eyedrop, Rhopressa, as a treatment for glaucoma, two months ahead of the expected date.
The company is planning to launch the drug by the middle of second quarter (Apr-Jun)in 2018 and around the same time aims to seek FDA approval for its second glaucoma eyedrop, Roclatan.
“We have been preparing for commercialization for well over a year,” Chief Executive Vicente Anido Jr said in a statement, adding that Aerie would hire 100 sales representatives early next year.
Aerie’s marketing application for Rhopressa in 2016 was delayed due to issues with the Florida-based facility where it was being manufactured.
In October, an advisory panel to the drug regulator had voted 9-1 in favor of Rhopressa’s approval.
Glaucoma affects about 2.7 million people in the United States and is the second leading cause of blindness in the world.
Rhopressa helps lower the pressure due to a build up of fluid in the eye by targeting the trabecular meshwork, the main drain through which fluid flows out of the eye.
The drug’s approval followed Valeant Pharmaceuticals International Inc’s announcement on Monday that it would begin shipping to U.S. wholesalers its Vyzulta, a rival treatment manufactured at the same facility.
Rhopressa’s approval is likely to increase Aerie’s appeal as “a prime acquisition target” for larger eyecare players, Serge Belanger, an analyst at Needham & Co, had said in a client note.
Aerie’s shares fell 1.3 percent to $57 after the bell. (Reporting by Tamara Mathias in Bengaluru; Editing by Arun Koyyur)