‘Real-world’ ocriplasmin macular hole closure rates lag trials
Ocriplasmin (Jetrea, ThromboGenics) may achieve lower macular hole closure rates than in trials, new British and Irish data suggests.
Also, “the incidence of adverse events was greater than previously reported,” wrote RJ Haynes of Bristol Eye Hospital in Bristol, United Kingdom, and colleagues in the journal Eye.
Vitreomacular traction can reduce visual acuity and cause metamorphopsia and central field defect. Ocriplasmin is intended to treat this condition by cleaving fibronectin, laminin, and collagen in the vitreous body and vitreoretinal interface.
In two phase III controlled trials, ocriplasmin resolved vitreomacular adhesion and vitreomacular traction in 26.5% of cases within 28 days. By comparison, only 10.1% of cases treated with a placebo resolved in that amount of time (N. Engl. J. Med 2012;367,:606-615).
Based on these Microplasmin for Intravitreous Injection—Traction Release without Surgical Treatment (MIVI TRUST) trials, the European Medicines Agency approved ocriplasmin in March 2012 for the treatment of vitreomacular traction, including cases associated with a macular hole of less than 400 µm.
The U.S. Food and Drug Administration (FDA) approved ocriplasmin for vitreomacular traction and symptomatic vitreomacular holes in October 2012, and the National Institute for Health and Care Excellence recommended it in October 2013 for use in England.
However, reports of adverse events have surfaced informally and in published case reports, prompting Haynes and colleagues to survey their colleagues in the British and Eire Association of VitreoRetinal Surgeons (BEAVRS).
They emailed all members of BEAVRS who had a registered email address in October 2014 and January 2015 and asked them report all cases of vitreomacular traction with or without full-thickness macular holes.
The researchers wanted to know how safe and effective the treatment would be in the “real-world” of clinical practice. Forty-one members responded that they had used ocriplasmin, and 7 that they had not, for a total response rate of 40%.
It is not clear from the survey what proportion of BEAVRS members use ocriplasmin, but at the organization’s annual meeting in 2014, only 8% said they would use the drug in a patient with a small full-thickness macular hole.