ThromboGenics sees eye drug on home stretch to approval
Leuven – ThromboGenics NV presented promising results of its Ocriplasmin Phase III clinical program at the Annual Meeting of the American Society of Retina Specialists (ASRS). „We remain on track to make regulatory filings for this novel compound in Europe and the U.S. by the year-end”, CEO Patrik de Haes said. Ocriplasmin is a novel pharmacological agent being investigated for the treatment of symptomatic vitreomacular adhesion (VMA) including macular holes. Symptomatic VMA is a condition when the vitreous gel adheres in an abnormally strong manner to the retina. VMA can lead to loss or distortion of visual acuity. In 2010, Ocriplasmin completed two Phase III trials involving a total of 652 patients in Europe and the U.S. New data now presented confirms that a single injection of ocriplasmin resolved VMA and the visual symptoms associated with it in 29.8% of VMT patients, compared with 7.7% of patients on placebo. After 6 months Ocriplasmin appears to lower the incidence of retinal tears or detachments, seen in just 1.7% of patients, compared with 4.3% on placebo. ThromboGenics says that there are approximately 500,000 patients in the U.S. and major markets of the EU who would benefit from ocriplasmin if it were approved for symptomatic VMA including macular holes.