Novartis blockbuster eye med wins FDA approval

Oct 08, 2019

The U.S. Food and Drug Administration approved Novartis' Beovu (brolucizumab) injection, also known as RTH258 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.

The approval of Beovu was based on findings from Phase III clinical trials in which Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one. In both clinical trials, approximately 30% of patients gained at least 15 letters at year one. 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), which 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.

Read the full Novartis release