Novartis has secured the US Food and Drug Administration (FDA) approval for the use of its Beovu (brolucizumab) medicine to treat wet age-related macular degeneration (AMD).
Wet AMD is a degenerative eye disease that develops due to excess VEGF protein, which stimulates the growth of abnormal blood vessels under the macula area of the retina linked to sharp, central vision.
Beovu is a humanised single-chain antibody fragment (scFv) designed to block VEGF activation. Inhibition suppresses the abnormal blood vessels growth and the risk of fluid leakage into the retina.
The Beovu molecule delivers the highest concentration of the antibody, indicated for a three-month dosing regimen following a three-month loading phase.
Novartis Pharmaceuticals president Marie-France Tschudin said: “The product labels of existing treatments state that they are not as effective when dosed every 12 weeks.
“Beovu is the first to offer less frequent dosing in the first year of therapy, while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what’s important in their lives.”
FDA approval comes from the results of the Phase III HAWK and HARRIER studies conducted in a total of more than 1,800 patients at approximately 400 sites.
During the 96-week studies, the safety and efficacy of 6mg and 3mg intravitreal injections of Novartis’ drug were compared to 2mg aflibercept.
Results showed non-inferiority of Novartis’ drug in mean change in best-corrected visual acuity (BCVA) at week 48, compared to aflibercept.
In both HAWK and HARRIER trials, around 30% of participants gained at least 15 letters at year one. Furthermore, Beovu demonstrated a decrease in central subfield thickness (CST) at week 16 and one year.
The overall safety profile of Novartis’ drug was comparable to that of aflibercept.