Aerie’s glaucoma treatment gets early FDA approval

2 months ago
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(Reuters) – Aerie Pharmaceuticals Inc said on Monday the U.S. Food and Drug Administration approved its eyedrop, Rhopressa, as a treatment for glaucoma, two months ahead of the expected date.

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.

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.

Rhopressa’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.

The drug’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 1.7 percent to $56.50 after the bell.

Reporting by Tamara Mathias in Bengaluru; Editing by Arun Koyyur

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