Xlucane™ is used in the treatment of wet form of Age-related Macular Degeneration (AMD), Diabetes-related Macular Edema (DME), Diabetic Retinopathy (DED) and Retinal Vein Occlusion (RVO). Overall it is estimated that all indications combined have 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 groups of the population globally and realize significant savings for the healthcare community. In 2021 the VEGFa inhibitor market for ophthalmic use generated sales of SEk 119bn out of which Lucentis® accounted for SEK 33bn billion.
Xbrane has completed the development of the production process for Xlucane™ on commercial scale and has demonstrated a high level of similarity compared with the originator product on the basis of a panel analysis method in accordance with guidelines from the EMA and FDA.
The confirmatory clinical equivalence phase III trial is continuing. In September 2021 an application for market approval to the EMA was submitted. Application for market approval to the FDA is expected to be made during 2022.
Xbrane has signed a co-development agreement for Xlucane™ with the German generic/biosimilar company STADA. Under the agreement Xbrane is responsible for developing the product and STADA for sales and marketing. Development expenses and profits generated from sales of the product will be shared 50/50. The North-American rights for the product have been out-licensed to Bausch+Lomb.