FDA approves Jetrea for symptomatic VMA in eyes
Wednesday, October 17, 2012
The FDA has approved ThromboGenics’ Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).
Jetrea is an enzyme that breaks down proteins in the eye responsible for VMA. The breakdown of these proteins allows a better separation between the vitreous and macula and can reduce the chances that tugging will occur. The alternative treatment for this condition is a surgical procedure called a vitrectomy.
“Today’s approval represents a significant advancement in treatment for patients with symptomatic VMA,” said Edward Cox, M.D., M.P.H., director of the office of antimicrobialproducts at the Center for Drug Evaluation and Research (CDER). “Those with this sight-threatening disease now have a non-surgical treatment option.”
The safety and effectiveness of Jetrea were established in two clinical studies involving 652 patients with symptomatic VMA. Patients were randomly assigned to receive a single injection of Jetrea into the eye or a substance without the active ingredient. Patients were evaluated over the next 28 days and for any side effects over the next six months. The studies found that VMA resolved in 26% of patients treated with Jetrea compared with 10% of those treated with the inactive product.
The most common side effects reported in patients treated with Jetrea include eye floaters; bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; flashes of light (photopsia); blurred vision; unclear vision; vision loss; retinal edema (swelling); and macular edema.