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Brolucizumab shows noninferiority to aflibercept for treatment of AMD
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MIAMI — Two phase 2 studies comparing brolucizumab vs. aflibercept for the treatment of neovascular age-related macular degeneration showed comparable efficacy results at 40 weeks of follow-up, according to a speaker here.
“There are two phase 2 studies, and their endpoint shows noninferiority to aflibercept and ranibizumab, justifying progression to a phase 3 study of brolucizumab. Brolucizumab has the potential to address a significant unmet clinical need in the treatment of neovascular AMD by reducing treatment burden,” Lawrence J. Singerman, MD, FACS, said at Angiogenesis, Exudation, and Degeneration 2017.
Two phase 2 studies were conducted to compare the drugs. In one study, patients were randomized 1:1 to 6 mg intravitreal brolucizumab (Alcon) or 2 mg Eylea (aflibercept, Regeneron). At week 12, patients receiving brolucizumab experienced non-inferior best corrected visual acuity changes from baseline when compared with patients receiving aflibercept. There were no notable differences up to 40 weeks, Singerman said.
Patients in the brolucizumab group had fewer rescue treatments and more stable central subfield thickness reductions, he said. The adverse events were similar between the two groups.
The results from both phase 2 studies showed enough treatment progression that two phase 3 studies comparing brolucizumab and aflibercept for the treatment of neovascular AMD have been approved, Singerman said.
“The treatment regimen of the HAWK and HARRIER phase 3 studies allows for evaluation of Q12 week brolucizumab treatment. The studies are fully enrolled as of June of 2016, with an estimated study completion time of May of 2018,” he said. – by Robert Linnehan
Reference:
Singerman LJ. Brolucizumab vs. aflibercept treatment for neovascular AMD. Presented at: Angiogenesis, Exudation, and Degeneration 2017; Feb. 11, 2017; Miami.
Disclosure: Singerman reports he receives grants/research support from Acucela, Alcon, Allergan, Apellis, Ohr, Ophthotech, Opthea, Roche-Genentech and Tyrogenex, and is a stock/shareholder with Ohr Pharmaceutical and Ophthotech.