Premacure intends to initiate a Phase II multicenter trial for Iplex in the retinopathy of prematurity indication during the second quarter of 2009.
With an orphan designation in Europe, Premacure is eligible for protocol assistance, as well as fee reductions for pre-authorization activities, including the application for marketing authorization, and inspections. Post-authorization activities, such as variations and annual fees, are also subject to fee reductions.