Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept). EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular edema, and diabetic retinopathy. According to Alvotech, the study “is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study, and is expected to enroll approximately 444 participants globally.” The primary endpoint of the study is change in best corrected visual acuity (BVCA) from baseline to week 8. Joseph McClellan, the Chief Scientific Officer at Alvotech, said that “the initiation of this patient study marks an important step in the development of our AVT06 biosimilar candidate, and demonstrates Alvotech’s commitment to developing biosimilars addressing key therapeutic areas in order to improve the lives of people around the world.”
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