Xlucane™ is used in the treatment of wet form of age-related macular degeneration (AMD), diabetes-related macular edema (DME), diabetic retinopathy (DME) and retinal vein occlusion (RVO). Overall it is estimated that all indications combined has a prevalence of over 18 million potential patients globally. Xlucane™ will provide a more cost-efficient treatment compared to the established VEGFa inhibitors Lucentis® and Eylea® and thereby make the treatment accessible to large population groups globally and realize significant savings to the healthcare community. In 2020 the VEGFa inhibitor market for ophthalmic use generated sales of EUR 10.1 billion out of which Lucentis® sold for EUR 3.1 billion.
Xbrane has completed the development of the production process for Xlucane™ at commercial scale and has demonstrated a high level of similarity compared with the originator product on the basis of a panel analysis methods in accordance with guidelines from EMA and FDA.
The confirmatory clinical equivalence phase III trial is ongoing. MAA/BLA is expected to be filed in 2021.
Xbrane has entered into a co-development agreement for Xlucane™ with the German generic/biosimilar company STADA. Under the agreement Xbrane is responsible for development of the product and STADA for sales and marketing. Development expenses and profits generated from sales of the product are shared 50/50. The North-American rights for the product has been out-licensed to Bausch+Lomb.