This article was reviewed by Arshad M. Khanani, MD, MA, and Joshua Mali, MD
Retinal specialists are ushering in the year 2020 with the availability of a new anti–vascular endothelial growth factor (VEGF) therapy, since the FDA approval of brolucizumab (Beovu, Novartis) for the treatment of patients with wet age-related macular degeneration (AMD) in the last quarter of 2019.
“[Brolucizumab] is a welcome treatment for patients, and it is the first new treatment for wet AMD in about eight years,” according to Joshua Mali, MD, vitreoretinal surgeon, private practice in Sarasota, FL.
“There has been a meticulous process to create a drug that provides advantages over currently available therapies for wet AMD,” Dr. Mali added. “[Brolucizumab] maintains robust visual gains and provides superior retinal drying compared with aflibercept with the potential for 12-week dosing intervals.”
As background, the FDA approval was based on the results of the phase III HAWK and HARRIER 2-year clinical trials that placed brolucizumab head-to-head with 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 Mali, who is also founder and chief executive officer 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, he noted.
“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 BCVA.”
Safety profiles of the two drugs were similar. A difference was seen in inflammation between brolucizumab and aflibercept, 4% and 1%, respectively.