Aerie Pharmaceuticals Inc. submitted Tuesday a new drug application for Food and Drug Administration approval of a new eye drop therapy for glaucoma, according to filings with the Securities and Exchange Commission released Tuesday.
The drug is expected to be the first once-a-day eye drop that specifically targets the eye’s primary fluid drainage system to relieve pressure in the eye, a defining symptom of glaucoma.
Its research and development efforts are based in Durham. The company is submitting the drug, called Rhopressa, for the last step before the drug can enter clinical trials.
“The Rhopressa NDA filing represents a significant achievement for Aerie. We are very proud of our many dedicated employees who worked tirelessly to have this filing submitted on schedule,” said chief executive officer Vicente Anido Jr.
Aerie sent two prior versions of Rhopressa into Phase 3 registration trials, the step before a new drug application, intended to provide evidence of the drug’s efficacy. It also has two on-going Phase 3 registration trials focused on safety evaluations for Canada and Europe. Neither of the on-going trials is necessary for Rhopressa to undergo FDA evaluation.
Aerie has a second drug, Roclatan, currently in Phase 3, that it expects will be ready for FDA evaluation by mid-2017.
The company expects Rhopressa will complete its review process in 12 months.
Aerie Pharmaceuticals’ stock price closed at $19.57 Tuesday, down 0.15 percent.
Note: This story is from the North Carolina Business News Wire, a service of UNC-Chapel Hill’s School of Media and Journalism
