Beovu FDA approval for wet AMD : Swiss pharma giant Novartis has been given approval from the US Food and Drug Administration (FDA) for Beovu (brolucizumab) injection for wet age-related macular degeneration (AMD).
Also called RTH258, Beovu is now the first FDA approved anti-VEGF which is said to deliver greater fluid resolution compared to aflibercept. The Novartis drug is also claimed to have the ability to maintain eligible wet AMD patients on a dosing interval of three months immediately following a three-month loading phase without any compromise in efficacy.
Marie-France Tschudin – President of Novartis Pharmaceuticals commenting on Beovu FDA approval for wet AMD, said: “The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment.
“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.”
Wet AMD is a chronic, degenerative eye disorder resulting due to surplus VEGF, which is a protein that fosters the growth of abnormal blood vessels underneath the macula, the area of the retina which helps in sharp, central vision.
According to Novartis, Beovu through its action of inhibiting VEGF, curbs the growth of abnormal blood vessels and the possibility for fluid leakage into the retina.
Beovu FDA approval for wet AMD was driven by the data from the phase 3 clinical trials – HAWK and HARRIER, in which the VEGF-inhibitor showed non-inferiority compared to aflibercept in mean change in best-corrected visual acuity (BCVA) at year one.
In the two late-stage clinical trials, nearly 30% of patients gained more than 15 letters at year one, said Novartis.
Beovu also demonstrated greater reduction in central subfield thickness (CST) as early as week 16 and at year one, and lesser patients had intra-retinal (IRF) and/or sub-retinal fluid (SRF) across the HAWK and HARRIER clinical trials.
Commenting on Beovu FDA approval for wet AMD, Dr. Pravin U. Dugel – principal investigator of the HAWK clinical trial said: “Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid.
“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.”
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