Brolucizumab Gets EU Panel Backing for Wet AMD

Marcia Frellick

December 13, 2019

A treatment for neovascular or "wet" age-related macular degeneration (AMD) called brolucizumab (Beovu, Novartis) won endorsement today from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

The opinion follows approval by the US Food and Drug Administration in October. Now, the European Commission will consider the CHMP recommendation; the manufacturer says a decision is expected in 3 months.

Wet AMD is a leading cause of vision loss in older adults and affects 20 million people worldwide.

The CHMP recommendation was based on findings from two phase 3 head-to-head trials (HAWK and HARRIER) in which brolucizumab, also known as RTH258, was shown to be noninferior to aflibercept (Eylea, Regeneron) in mean change of best-corrected visual acuity over 1 year. Those trials randomly assigned 1800 patients to one of the two treatments at 408 sites globally.

In both trials, about 30% of patients treated with brolucizumab gained at least 15 letters at year 1, according to a company press release.

In addition, brolucizumab demonstrated a safety profile similar to that of aflibercept. The most common adverse effects were blurred vision, cataract, floaters, eye pain, and conjunctival hemorrhage.

Wet AMD happens when uncontrolled vascular endothelial growth factor (VEGF) causes abnormal blood vessels behind the retina to grow under the macula, leading to blood and fluid leaks that damage central vision. Brolucizumab inhibits VEGF to stop the growth of the vessels and subsequent leakage.

The company notes that in a key secondary endpoint more than half of patients treated with brolucizumab 6 mg (56% in HAWK and 51% in HARRIER) were maintained on 3-month dosing intervals through year 1.

That is key, the company notes, because having to receive more frequent injections is a key reason people with wet AMD stop treatment.

"There are two good reasons" for why another treatment option is needed and why brolucizumab may fill that need, according to Sophie J. Bakri, MD, a professor in the department of ophthalmology at the Mayo Clinic in Rochester, Minnesota, in a Medscape commentary: "efficacy and duration," she writes.

"Despite even monthly treatment, a large proportion of patients with wet AMD still have fluid on optical coherence tomography," she said. "The search has therefore continued for a more efficacious drug that also lasts longer in the eye."

More information about the recommendation is available on the European Medicines Agency website.

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