NEW ORLEANS — Novartis’ first-in-kind molecule brolucizumab achieved clinically relevant anatomic and visual acuity gains in patients with age-related macular degeneration with every-12-week dosing, according to a speaker.
Two dosages of the single-chain antibody fragment VEGF inhibitor were compared with Eylea (aflibercept, Regeneron) in two phase 3 trials, HAWK and HARRIER, Pravin U. Dugel, MD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting, where he reported 48-week results.
Not only did brolucizumab meet the primary endpoint of noninferiority in change in best corrected visual acuity from baseline, achieving “robust and consistent visual gains,” but also the majority of brolucizumab patients were exclusively maintained on an every-12-week dosing interval immediately after the loading phase, he said.
“From the time of enrollment through week 16, there was an opportunity for a direct head-to-head comparison vs. aflibercept. ... Significantly fewer patients on brolucizumab had disease activity at the head-to-head assessment,” Dugel said. Brolucizumab also achieved superior reductions in central subfield thickness vs. aflibercept in both the head-to-head and maintenance phases, according to Dugel.
Overall safety of brolucizumab was comparable to aflibercept and consistent with other anti-VEGF drugs, Dugel said.
“Brolucizumab demonstrated noninferiority in BCVA vs. aflibercept with a majority of patients maintained on a q12-week interval, significantly less disease activity at week 16, superior central subfield thickness reductions at weeks 16 and 48, significantly fewer patients with presence of intraretinal fluid and/or subretinal fluid, fewer patients with sub-RPE fluid and overall safety comparable to aflibercept,” Dugel said. – by Patricia Nale, ELS
Dugel PU. HAWK and HARRIER: 48-week results of two multicentered, randomized, double-masked trials of brolucizumab vs. aflibercept for neovascular AMD. Presented at AAO Subspecialty Days; Nov. 10-11, 2017; New Orleans.
Disclosure: Dugel reports he is a consultant for Alcon and Novartis.