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Eye Drug Shows Promise in Elderly Patients
An experimental drug that could reduce risky eye surgery in elderly patients showed promising results in two phase III studies published online on August 16 in the New England Journal of Medicine. In the studies, a single intravitreal injection of ocriplasmin was more effective than placebo at resolving vitreomacular adhesion (VMA).
The randomized, double-blind phase III trials were conducted in the U.S. and Europe and involved 652 patients with VMA. Both studies met the primary endpoint of pharmacological resolution of VMA at day 28. Secondary endpoints included nonsurgical closure of a macular hole at 28 days, avoidance of vitrectomy (surgery), and improvement in visual acuity.
The phase III program found that 26.5% of patients treated with ocriplasmin experienced resolution of VMA compared with 10.1% of patients receiving placebo (P P
Symptomatic VMA is a progressive condition that, if left untreated, has the potential to cause irreversible retinal damage and complications. According to ThromboGenics, the drug’s manufacturer, approximately 500,000 patients in the U.S. and the major E.U. markets could potentially benefit from treatment with ocriplasmin annually. If approved by the FDA, ocriplasmin would be the first pharmacological treatment for symptomatic VMA in the U.S.
Ocriplasmin is a recombinant protease with activity against fibronectin and laminin, components of the vitreoretinal interface.
For more information, visit the NEJM Web site.