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Phase 3b trial to evaluate brolucizumab for wet AMD
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Novartis announced a phase 3b clinical trial to evaluate brolucizumab vs. aflibercept in the treatment of wet age-related macular degeneration.
The TALON trial is the first treat-to-control study and aims to demonstrate brolucizumab’s superiority in treatment interval duration, while maintaining noninferiority in visual acuity change, Joanne Chang, Novartis Ophthalmology’s worldwide medical affairs head, told Healio.com/OSN.
“We believe TALON will demonstrate that brolucizumab can enable an earlier treatment interval extension — up to 16 weeks — and that more patients can be treated with a longer treatment interval vs. aflibercept,” she said. “By increasing the time between treatments, brolucizumab has potential to reduce the treatment burden on wet AMD patients and their caregivers.”
The global, double-masked, multicenter, randomized trial will compare brolucizumab 6 mg and aflibercept 2 mg in 692 patients randomly assigned into two treatment arms.
“The study’s treat-to-control regimen is designed to reflect clinical practice and determine the optimum treatment interval for each patient based on disease activity,” Chang said. “The focus is on sustaining disease control and extending the treatment interval when clinically appropriate. In clinical practice, patients may benefit from a customized approach to treatment based on individual response to therapy, some being maintained on a more frequent treatment interval and others on a more extended interval in order to control disease activity.” - by Rebecca L. Forand
Disclosure: Chang reports she is worldwide medical affairs head, Novartis Ophthalmology.