EMA accepts Isotechnika-Lux filing for eye drug

The European Medicines Agency has accepted a marketing application filed by Isotechnika Pharma’s (TSX:ISA) partner, Lux Biosciences, for voclosporin to treat non-infectious uveitis involving the posterior segment of the eye, the fourth leading cause of legal blindness in the industrialized world.

“With the EMA acceptance of the dossier we now expect the review process to be completed by the end of February 2011,” Isotechnika CEO Dr. Robert Foster said in a statement.  “With approval, this will result in a milestone payment of $3.52 million (U.S.) and royalty payments on sales from our partner, Lux.”

Isotechnika and Lux also expect to hear from the FDA by April about the acceptance of their U.S. dossier for voclosporin.