A publicly traded drug-development company co-founded by two Duke University professors has pushed back the timetable on its experimental glaucoma treatment.
New Jersey-based Aerie Pharmaceuticals, which has research-and-development operations in Durham, announced last week that the contract manufacturer that would produce the glaucoma drug Rhopressa in Tampa, Fla., won’t be ready for the Food and Drug Administration’s pre-approval inspection until the end of February.
As a result Aerie, which had been planning to resubmit its application to the FDA in January, is now projecting that it will do so near the end of March.
This is the second Rhopressa-related delay triggered by issues at the Florida manufacturing facility. Aerie withdrew its New Drug Application for Rhopressa in October because the facility wasn’t ready for pre-approval inspection.
Aerie said in its latest announcement that the new delay “apparently does not result from any new findings,” but instead was the result of “additional time needed to complete validation of new equipment.”
Richard Rubino, the company’s chief financial officer, couldn’t immediately be reached for additional comment.
Rhopressa eye drops would be used to treat glaucoma by administering them once daily in the evening. The drug is designed to reduce eye pressure that causes vision loss.
Aerie, which doesn’t have any drugs on the market, went public three years ago. It was co-founded in 2005 by the late David Epstein, who was a medical professor at Duke, and Eric Toone, the university’s vice provost and director of its Innovation and Entrepreneurship Initiative.
According to the Glaucoma Research Foundation, more than 120,000 Americans are blind from glaucoma and it is estimated that more than 3 million Americans have the disease, although only half of them know they have it.
Aerie shares were trading at $37.50, down $1, on Wednesday. The company’s shares have risen 54 percent this year.