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Vitreous hemorrhage drug filed for regulatory approval in EU
IRVINE, Calif. — An ovine hyaluronidase treatment for vitreous hemorrhage will be reviewed by the European Medicines Evaluation Agency for regulatory approval, the drug’s marketer said in a press release.
Ista Pharmaceuticals submitted Vitragan (ovine hyaluronidase) for the treatment of vitreous hemorrhage to regulators last year and received word earlier this week the centralized marketing authorization application had been accepted. Ista markets Vitragan in the United States as Vitrase.
The filing was based upon existing clinical trial data, including results from two randomized, double-masked, placebo-controlled international phase 3 trials. The data showed a statistically significant reduction in vitreous hemorrhage density as early as 1 month that persisted through 3 months after a single intravitreous injection when compared to a single injection of saline.
The company expects a decision from the EMEA by the first half of 2007, according to the release.