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news.ISTA Pharmaceuticals' application to market Vitragan, a treatment for a serious eye condition known as vitreous hemorrhage, has been accepted for review by European regulatory authorities.
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Vitragan is ISTA’s proprietary formulation of highly purified ovine hyaluronidase, which is commonly known in the US as vitrase. A vitreous hemorrhage occurs when retinal blood vessels rupture and bleed into the vitreous humor. These hemorrhages result from leakage from abnormal, weak blood vessels and are associated with trauma, diabetic retinopathy and other factors. Such a condition can result in blindness.
“ISTA has accumulated a wealth of clinical data demonstrating that Vitrase can have a meaningful impact on reducing hemorrhage density and improving best-corrected visual acuity after only a single dose of treatment,” stated Dr Vicente Anido, president and CEO of ISTA.
Dr Anido called the product’s acceptance for review by the European Medicines Evaluations Agency (EMEA) a milestone for the company.
ISTA filed its Vitragan marketing authorization application (MAA) in the EU during the third quarter of 2005 and expects to have a decision by the first half of 2007. The filing was based primarily upon the company’s existing clinical trial data, including results from two international phase III clinical trials.