Xbrane Files FDA Application to Begin Study of Xlucane, a Biosimilar of Lucentis

Xbrane reported Dec. 19 that it has filed an application with the US FDA for a pivotal Phase III trial of Xlucane as a biosimilar to Lucentis in patients with wet age-related macular degeneration.

The Swedish company plans to begin the trial in March 2019. It said it will submit applications to other countries within the next two months.

Xbrane said the study design was developed in consultation with the FDA and European Medicines Agency.

The primary efficacy endpoint is change in visual acuity at eight weeks. Secondary endpoints for efficacy, safety, and immunogenicity will be evaluated for 12 months. The study will enroll about 600 patients across 150 sites in 16 countries.

Xbrane announced in July that it entered a co-development agreement with STADA for Xlucane, with the companies sharing development costs and profits equally.