FDA approves for Beovu for wet age-related macular degeneration with three month dosing intervals.- Novartis

Novartis announced that the FDA approved Beovu (brolucizumab) injection, also known as RTH 258 for the treatment of wet age-related macular degeneration (AMD). Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy.

�Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,� said Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of the HAWK clinical trial. �With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.�

The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one (week 48). In both clinical trials, approximately 30% of patients gained at least 15 letters at year one . In HAWK and HARRIER, Beovu showed greater reduction in central subfield thickness (CST) as early as week 16 and at year one, and fewer patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF). Retinal fluid is a key marker of disease activity.

Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision. Fluid that leaks out of these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula. The Beovu molecule is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs. By inhibiting VEGF, Beovu suppresses the growth of abnormal blood vessels and the potential for fluid leakage into the retina.