Two phase III studies of ocriplasmin (ThromboGenics) have fond that the truncated form of the human serine protease plasmin significantly resolved vitreomacular traction (VMT) and closed macular holes compared with placebo in patients with vitreomacular adhesion (VMA), according to findings published in the New England Journal of Medicine.
Basel, Switzerland-Two phase III studies of ocriplasmin (ThromboGenics) have found that the truncated form of the human serine protease plasmin significantly resolved vitreomacular traction (VMT) and closed macular holes compared with placebo in patients with vitreomacular adhesion (VMA), according to findings published in the New England Journal of Medicine.
“Results . . . demonstrate the potential for using an enzymatic approach to resolve VMA. This represents a real advance for patients living with VMA, who currently only have the option of surgery at a later stage of the disease,” said lead author, Peter Stalmans, MD, PhD, of the Department of Ophthalmology at University Hospitals in Leuven, Belgium.
In July, the FDA Dermatologic and Ophthalmic Drugs Advisory Committee recommended approval of the use of intravitreal ocriplasmin in the United States. If approved, ocriplasmin could become the first pharmaceutical therapy to treat patients with VMA.
“An in-office injection would be a new and possibly earlier alternative treatment for the vitreoretinal surgeon to offer to patients with these sight-threatening disorders,” said co-author, Julia Haller, MD. “Ocriplasmin represents a potential new treatment paradigm for the retina community and for our patients with VMA and macular holes.”
Dr. Haller is ophthalmologist-in-chief of the Wills Eye Institute, professor and chairwoman of the Department of Ophthalmology at Thomas Jefferson University, Philadelphia, and a member of the editorial advisory board of Ophthalmology Times.
The European Medicines Agency is reviewing ocriplasmin for use in the European Union. ThromboGenics retains the rights to commercialize the drug in the United States. Alcon, a division of Novartis, acquired from ThromboGenics the rights to commercialize ocriplasmin outside the United States.
“The data from these studies provide a basis for worldwide regulatory filings,” said Kevin Buehler, division head, Alcon.
The two multicenter, randomized, double-blind, placebo-controlled phase III studies involved 652 patients and tested the efficacy and safety of a single, 125-µg intravitreal injection of ocriplasmin in patients with VMT and macular holes. The primary endpoint for the studies was the percentage of eyes with nonsurgical resolution of VMA at day 28, determined by optical coherence tomography imaging.
After 28 days, following a single administration of ocriplasmin, resolution of VMA was observed in 26.5% of patients, compared with 10.1% in the placebo group. This statistically significant difference was maintained through 6 months of observation.
For the majority of patients with resolution of VMA after ocriplasmin administration, resolution was achieved within 7 days. By the end of the 6-month observation period, fewer patients required a vitrectomy in the ocriplasmin-treated group compared with placebo (17.7% versus 26.6%, respectively). Nonsurgical closure of macular holes occurred in 40.6% of the treated patients, compared with only 10.6% of placebo patients. This difference was also statistically significant.
The most common adverse event in the ocriplasmin-treated group was self-reported vitreous floaters (68.4% compared with 53.5% in the placebo group). The incidence of any serious ocular adverse event was 7.7% in the ocriplasmin group, compared with 10.7% in the placebo group.
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