Published: 19 October 2012
Washington-the FDA approved Ocriplasmin (Jetrea) as the first non-surgical treatment for symptomatic Vitreomacular adhesion.
Symptomatic Vitreomacular adhesion is a condition where the jelly in the Makula-moves-called vitreous-that can damage the macula by pulling or tugging, wrote the Agency in a statement.
The drug is supplied by an injection into the eye, where the enzyme in the treatment consists of ocular proteins responsible for adhesion. The drug allows "a better separation between the vitreous and macula, and greatly reduces the chances that pluck will occur," said the Agency.
Safety and efficacy were founded two clinical trials with a combined 652 patients with symptomatic Vitreomacular adhesion. Patients received an injection then followed for 28 days and tested for side effects for 6 months randomized Ocriplasmin or placebo.
In the combined trials, 26% of patients with Ocriplasmin were treated free from liability compared to 10% of patients treated with placebo.
Adverse events related to treatment including mouches volantes, bleeding of the eyelids and eyes tissue, eye pain, Photopsia, verschwommenes see, Sehverlust, unclear vision, retinal swelling and macular edema.
The Agency noted that the drug allows patients have a"non-surgical treatment option", said Edward Cox, MD, Director of the Office drug evaluation and research, in the release anti-microbial products in the FDA's Center for. The surgical treatment for a symptomatic Vitreomacular adhesion is called vitrectomy involves the cutting of vitreous gel and suck it out.
The drug is made by ThromboGenics.
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