The FDA today approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).
VMA can contribute to eye problems if the vitreous (jelly-like matter in the center of the eye) starts to move away from the macula (part of the retina responsible for reading vision). This movement can lead to damage of the macula due to pulling or tugging on it.
Ocriplasmin, the active ingredient of 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. An alternative treatment for this condition is a surgical procedure called a vitrectomy.
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 6 months. The studies found that VMA resolved in 26% of patients treated with Jetrea compared with with 10% of those treated with 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.
Jetrea is manufactured by Iselin, N.J.-based ThromboGenics Inc.