FDA Priority Review Granted for Ocriplasmin for Treatment of VMA

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The US Food and Drug Administration (FDA) has granted priority review designation to ocriplasmin (microplasmin, ThromboGenics NV) for the treatment of symptomatic vitreomacular adhesion (VMA), including macular hole, according to a company news release. ThromboGenics said it has withdrawn its current filing to the FDA, made on December 23, 2011, and will resubmit a biological license application for ocriplasmin by April. The resubmission will allow ThromboGenics to meet the preapproval inspection timelines and to manage the phasing of its resources to support both its European and US ocriplasmin filings, according to ThromboGenics.

The FDA grants priority review designation to drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has a goal of completing a priority review in 6 months. Two phase 3 trials, the MIVI-TRUST trials, examined 652 patients with vitreomacular traction, macular hole, or macular pucker.¹ Study participants were randomly assigned to receive a single intravitreal injection of 125 μg microplasmin (n=464) or 100 μL placebo solution (n=188). The primary efficacy endpoint was the proportion of patients who achieved resolution of symptomatic VMA at day 28 by masked optical coherence tomography at a central reading center.

The primary endpoint was met, with 26.5% of microplasmin-treated patients achieving pharmacologic resolution of symptomatic VMA compared with 10.1% of patients in the control group (P < .001). Secondary endpoints were also met. At day 28, microplasmin showed a statistically significant effect vs placebo: 40.6% of participants had pharmacologic macular hole closure, which was maintained at month 6 (P < .001), and pharmacologic induction of total posterior vitreous detachment occurred in 13.4% of patients (P < .001). No safety concerns were highlighted in these trials.

1. Dugel PU, MIVI-TRUST Study Group. A single injection of ocriplasmin for the treatment of symptomatic vitreomacular adhesion (sVMA): results of the phase III MIVI-TRUST program. Paper presented at: the Association for Research in Vision and Ophthalmology Annual Meeting; May 1-5, 2011; Fort Lauderdale, FL. Abstract 6628.

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