FDA approves brolucizumab injection for treatment of neovascular AMD

The Food and Drug Administration has approved brolucizumab injection for the treatment of neovascular or wet age-related macular degeneration (AMD). The approval has been granted to Novartis and Beovu injection is supplied as a 6mg/0.05mL solution in a single-dose vial.

U.S. Food and Drug Administration (FDA) has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD).

Beovu is the first Food and Drug Administration approved anti-VEGF that offers greater fluid resolution versus aflibercept and efficiently maintains eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase.

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 leaking out of these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula.

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).

“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, the 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.”

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). The retinal fluid is a key marker of disease activity.

Fluid leaking 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 the 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.

“The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “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.”

In HAWK and HARRIER, eligible patients could be maintained on a three-month dosing interval immediately after the loading phase. At year one, over half of the patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER). The remaining patients in the study were treated on a two-month dosing schedule.

Beovu exhibited an overall safety profile comparable to aflibercept. Beovu is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or with known hypersensitivity to brolucizumab or any of the excipients in Beovu. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema or severe intraocular inflammation.

The most common adverse events (>=5% of patients) with Beovu were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain.

Wet AMD distorts central vision and ultimately causes blindness and loss of independence. Estimates suggest that in 2020, 1.75 million people in the U.S. will be living with wet AMD, making it a growing public health concern. Early symptoms of wet AMD include blurry or wavy vision. As the disease progresses, patients lose central vision so it becomes difficult to see objects directly in front of them.

“As sight disappears, so does a person’s connection to the world,” said Dawn Prall, Founder and Executive Director, The Support Sight Foundation. “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.”

With this approval, Novartis is offering BEOVU Your WayTM in the U.S. This program provides personalized, one-on-one support for patients and caregivers, with access to a care specialist committed to understanding patients’ unique needs and preferences. Novartis is proud to be partnering with patient advocacy organizations to deliver educational materials for patients and caregivers, with the goal of empowering wet AMD patients to live safely and independently.

For more information visit novartis.com