by: Lynda Charters
This article was reviewed by Arshad M. Khanani, MD, MA; Joshua Mali, MD; and Patrick Mooney
Brolucizumab (RTH258, Beovu, Novartis) received FDA approval for treatment of patients with wet age-related macular degeneration (AMD) during the last quarter of 2019. The approval was based on the results of the phase III HAWK and HARRIER 2-year clinical trials that pitted brolucizumab head-to-head against aflibercept (Eylea, Regeneron Pharmaceuticals).
The key finding was that in both study arms at 48 weeks and two years brolucizumab achieved its primary endpoint and was found to be noninferior to aflibercept regarding the best-corrected visual acuity [BCVA].
“An important point to consider is that the dosing of the two drugs was quite different, with aflibercept dosed every four weeks for three loading doses with subsequent extension to every eight weeks,” according to Joshua Mali, MD, a vitreoretinal surgeon in private practice in Sarasota, FL, and founder and CEO of Mali Enterprises. “In contrast, brolucizumab was dosed every four weeks for three loading doses and then extension to every eight or potentially 12 weeks based on the assessment of the disease activity.”
Other relevant findings, Dr. Mali pointed out, were that the visual gains achieved with brolucizumab were noninferior to those achieved with aflibercept at the two time points with longer treatment intervals in most patients; about 56% of patients in the HAWK trial and 51% in the HARRIER being treated with brolucizumab were maintained on three-month dosing during the first year.
In addition, the central retinal thickness in patients receiving brolucizumab in both study arms decreased more compared with aflibercept at both week 16 and years one and two.
“Retinal fluid is a critical indicator of disease activity in patients with wet AMD and how they are responding to treatment,” he said. “The presence of fluid is also an extremely important factor in the determination of the BCVA.”
The safety profiles of the two drugs were similar. A difference was seen in intraocular inflammation between brolucizumab and aflibercept, 4% and 1%, respectively.
“Beovu is a welcome treatment for patients, and it is the first new treatment for wet AMD in about eight years,” Dr. Mali concluded. “There has been a meticulous process to create a drug that provides advantages over the currently available therapies for wet AMD. Beovu maintains robust visual gains and provides superior retinal drying compared with aflibercept with the potential for 12-week dosing intervals. Physicians and patients are very excited and optimistic about this treatment.”…