Novartis reports further 'positive' results from brolucizumab trials
Novartis announced further positive results from two Phase III studies of brolucizumab versus aflibercept. Results showed non-inferiority in primary endpoint, superiority in key retinal health outcomes, and long-lasting effect in patients with neovascular age-related macular degeneration, a leading cause of blindness. The results of the head-to-head trials, HAWK and HARRIER, were presented at the American Academy of Ophthalmology 2017 Annual Meeting. In neovascular AMD, abnormal blood vessels leak fluid into the eye, ultimately causing damage and blindness. At week 16, relative to aflibercept, 35% fewer brolucizumab 6 mg patients showed presence of IRF and/or SRF in HAWK, and 33% fewer in HARRIER. Again at week 48, relative to aflibercept, 31% fewer patients on brolucizumab 6 mg had intra-retinal fluid and/or sub-retinal fluid in HAWK, and 41% fewer in HARRIER. The absence of fluid for patients in the brolucizumab arm suggests the potential for a long-lasting effect and decreased treatment need. Brolucizumab met the primary efficacy endpoint of noninferiority to aflibercept in mean change in best-corrected visual acuity from baseline to week 48 in both trials. These results were achieved while a majority of brolucizumab patients-57% in HAWK and 52% in HARRIER-were maintained on a q12w dosing interval immediately following the loading phase through week 48. "HAWK and HARRIER demonstrated that brolucizumab has the potential to positively impact disease management and provide long-lasting treatment effect," said Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of both trials. "HAWK and HARRIER showed that brolucizumab outperformed aflibercept on disease activity assessments, including key measures of disease progression seen on OCT, which forms the basis of a clinician's treatment decisions. Importantly, improvements in these key OCT measures were seen as early as week 16 and maintained at week 48, with a majority of brolucizumab patients on a 12-week treatment interval."