Novagali gets FDA OK for Ph III study

French drugmaker Novagali Pharma says that an Investigational New Drug application, requesting approval to conduct a Phase III trial of its developmental dry-eye syndrome treatment Nova22007, has been accepted by the US Food and Drug Administration. The FDA based its decision on a review of data from a Phase II study in which the drug was examined as a therapy for Sjogren syndrome, a condition associated with keratoconjunctivitis sicca.

Jerome Martinez, Novagali president, said: "FDA clearance of [the] Nova22007 IND for a pivotal Phase III study represents an important milestone for Novagali, validating our ocular technology platform Novasorb." He added that the go ahead to conduct a trial in the USA, coupled with a similar study in Europe, would enable registration of the drug in both regions in the near future.