FDA approves 'first non-surgical treatment' for vitreomacular adhesion
medwireNews: The US Food and Drug Administration (FDA) reports the approval of ocriplasmin for the treatment of symptomatic vitreomacular adhesion (VMA).
The safety and efficacy of the drug have been previously assessed in two randomized controlled trials published in the New England Journal of Medicine, which involved over 600 patients with the condition, and showed a significantly higher rate of VMA resolution after ocriplasmin versus placebo.
Speaking about the FDA's decision on 17 October 2012, Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research (Silver Spring, Maryland, USA), said: "Today's approval represents a significant advancement in treatment for patients with symptomatic VMA. Those with this sight-threatening disease now have a non-surgical treatment option."
VMA is characterized by the vitreous jelly in the eye adhering strongly to the retina and moving away from the macula - the part of the eye responsible for reading vision - which can cause tugging or pulling on the macula, and can lead to serious damage and eventually, loss of sight.
"Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface," explain Julia Haller (Willis Eye Institute, Philadelphia, Pennsylvania) and colleagues, authors of the clinical trials.
The alternative treatment for VMA is vitrectomy, notes the FDA statement, a surgical procedure that involves cutting the vitreous gel in the eye and sucking it out.
In Haller et al's study, vitreomacular adhesion resolved in 26.5% of 464 VMA patients treated with a single injection of ocriplasmin, compared with 10.1% of 188 placebo-injected patients. In addition, the research team found that total posterior vitreous detachment was significantly more frequent among patients who had received ocriplasmin than those who had received placebo, at 13.4% versus 3.7%.
However, the researchers report a higher rate of ocular adverse events in ocriplasmin-treated eyes over the 6-month follow-up period, including vitreous floaters, photopsia (flashes of light), injection-related eye pain, blurred or unclear vision, and conjunctival bleeding. Despite this, the rate of serious adverse events was similar in both groups.
"Intravitreal injection of ocriplasmin was superior to injection of placebo in altering the vitreoretinal interface of affected eyes, although it was accompanied by some, mainly transient, ocular adverse events," conclude Haller and co-investigators.
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By Sarah Guy, medwireNews Reporter