New data for brolucizumab from HAWK and HARRIER trials for neovascular age-related macular degeneration.- Novartis.

Novartis has announced new positive brolucizumab (RTH258) data in neovascular age-related macular degeneration (nAMD) from a pre-specified secondary analysis of the Phase III HAWK and HARRIER trials. The findings showed that patients assessed as appropriate for a 12-week treatment frequency during the first 12-week cycle after loading could reliably stay on that quarterly interval through week 48. This is the first time a high level of reliability has been prospectively demonstrated for a pre-specified secondary endpoint of a 12-week dosing interval with an anti-vascular endothelial growth factor (VEGF) therapy in Phase III trials. These additional data were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting, in a follow-up to data presented in November 2017 at the American Academy of Ophthalmology.

The new findings showed that brolucizumab 6 mg patients who were suitable for 12-week treatment intervals during the first 12-week cycle after the loading phase had an 87% (HAWK) and 83% (HARRIER) probability of remaining on this quarterly treatment interval through week 48. The ability to reliably assess the likelihood of patients remaining on quarterly dosing could help physicians and patients better manage, personalize and optimize treatment plans.

"The ability to quickly identify patients who can maintain a 12-week interval has the potential to simplify treatment plans for nAMD patients," said Glenn J. Jaffe, M.D., Chief of Retinal Ophthalmology, Duke University, and an author of the presentation. "These robust data may offer physicians confidence that when 12-week dosing with brolucizumab is initially successful, there is high probability that the patient will maintain this interval through the first year of treatment." Brolucizumab safety was comparable to aflibercept with the overall incidence of adverse events balanced across all treatment groups in both studies. The most frequent ocular adverse events (greater than 5% of patients in any treatment arm) were reduced visual acuity, conjunctival hemorrhage, vitreous floaters and eye pain. The most frequent non-ocular adverse events were typical of those reported in an nAMD population; there were no notable differences between arms.