The US Food and Drug Administration (FDA) has approved brolucizumab (Beovu, Novartis) injection for wet age-related macular degeneration (AMD), according to a company news release.
"Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid," Pravin U. Dugel, MD, clinical professor, Roski Eye Institute, Keck School of Medicine, University of Southern California and principal investigator of the HAWK clinical trial, said in the release.
Wet AMD is a chronic, degenerative eye disorder in which an excess of the protein VEGF causes abnormal blood vessels to grow beneath the retina and macula, causing fluid to leak out. This distorts the central vision and eventually causes blindness. According to estimates, 1.75 million people in the United States will have the disease by 2020.
Brolucizumab delivers a high concentration of the medication and its active binding agents compared with other anti-VEGF medications, according to the company.
"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," Dugel explained.
Brolucizumab, also known as RTH258, can be administered to eligible patients with wet AMD every 3 months immediately after a loading phase of 3 months.
The approval follows consideration of data from two phase III trials, HAWK and HARRIER. Brolucizumab was noninferior to aflibercept (Eylea, Regeneron) injection with regard to mean change in best-corrected visual acuity at year 1 (week 48).
Approximately 30% of patients in both studies gained 15 or more letters at year 1. Patients in both studies experienced more reduced central subfield thickness with brolucizumab compared with aflibercept as soon as week 16 and at year 1. Fewer patients taking brolucizumab developed intra-retinal and/or sub-retinal fluid. Retinal fluid is a critical marker of disease activity, according to the news release.
At year 1, 56% of patients in HAWK and 51% of patients in HARRIER were maintained on an every-3-month dosing schedule and the remaining patients followed a 2-month dosing schedule.
"As sight disappears, so does a person’s connection to the world," Dawn Prall, founder and executive director of The Support Sight Foundation, said in the news release. "We welcome a new treatment that helps maintain vision and has the potential for quarterly treatments, which can reduce the burden on patients and their caregivers and help people with wet AMD keep doing what they love with the people they love."
The overall safety profile of brolucizumab was similar to that of aflibercept. Brolucizumab is contraindicated in those who have ocular or periocular infections, active intraocular inflammation or known hypersensitivity to brolucizumab or any of the product's excipients. Signs and symptoms of hypersensitivity reactions include rash, itching, urticaria, erythema, or severe intraocular inflammation.
The most frequent adverse events that occurred in at least 5% of patients were blurred vision, cataract, conjunctival hemorrhage, vitreous floaters, and eye pain.
"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," said Marie-France Tschudin, president of Novartis Pharmaceuticals, in the news release.
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Cite this: FDA Approves New Injection Brolucizumab (Beovu ) for Wet AMD - Medscape - Oct 08, 2019.