WASHINGTON -- The FDA has approved ocriplasmin (Jetrea) as the first nonsurgical treatment for symptomatic vitreomacular adhesion.
Symptomatic vitreomacular adhesion is a condition where the jelly around the macula -- called vitreous -- moves away from it, which can damage the macula by tugging or pulling on it, the agency wrote in a statement.
The drug is delivered through an injection into the eye, where the enzyme in the treatment breaks down the ocular proteins responsible for the adhesion. The drug permits "a better separation between the vitreous and macula, and can reduce the chances that tugging will occur," the agency said.
Safety and efficacy were established in two clinical trials of a combined 652 patients with symptomatic vitreomacular adhesion. Patients were randomized to receive an injection of ocriplasmin or placebo, then followed for 28 days and checked for adverse events over 6 months.
In the combined trials, 26% of patients treated with ocriplasmin were free of the adhesion versus 10% of those treated with placebo.
Adverse events related to treatment included eye floaters, bleeding of eyelid and eye tissue, eye pain, photopsia, blurred vision, unclear vision, vision loss, retinal swelling, and macular edema.
The agency noted that the drug allows patients to "have a nonsurgical treatment option," Edward Cox, MD, director of the Office of Antimicrobial Products at the FDA's Center for Drug Evaluation and Research, said in the statement. The surgical treatment for symptomatic vitreomacular adhesion is known as vitrectomy and involves cutting the vitreous gel and sucking it out.
The drug is manufactured by ThromboGenics.
Cole Petrochko
Staff Writer
Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.
No comments:
Post a Comment