DURHAM — Aerie Pharmaceuticals, Inc., an ophthalmic pharmaceutical company, announced Tuesday that the U.S. Food and Drug Administration (FDA) gave the company permission to commence clinical studies for a dry eye treatment, according to a press release.
Approval for a clinical trial for AR-15512 eye drop for dry eye was given after the Durham-based company filed an Investigational New Drug Application (IND) with the FDA.
Aerie anticipates the Phase 2b clinical study will begin in the fourth quarter of 2020.
The new drug was included in Aerie’s November 2019 acquisition of the Spanish company Avizorex Pharma, S.L., another ophthalmic pharmaceutical company specializing in dry eye disease treatment.
Avizorex had previously completed a Phase 2a clinical study for AR-1552 (then called AVX-012) on dry eye subjects in 2019.
“We expect to commence a Phase 2b clinical study [for AR-1552], which will be powered as a Phase 3, later this year, with a topline readout expected in the third quarter of 2021,” said Aerie CEO Vicente Anido, Jr., Ph.D.
The company also produces Rocklatan and Rhopressa, used to treat open-angle glaucoma and ocular hypertension.
The approval of the IND for AR-1552 marks the company’s first dry eye treatment candidate, which Anido called “an important milestone for the company.”
Aerie Pharmaceuticals Inc. (AERI) shares rose 7 cents on Thursday to close at $11.84.
This story is from the North Carolina Business News Wire, a service of UNC-Chapel Hill’s School of Media and Journalism.
