This is the first time a high level of reliability has been prospectively demonstrated for a prespecified secondary endpoint of a 12-week dosing interval with an anti-VEGF therapy in phase 3 trials. These additional data were presented at the ARVO 2018 Annual Meeting. Last June, the company announced positive results from these 2 phase 3 studies of brolucizumab, showing noninferiority to aflibercept in mean change in BCVA from baseline to week 48.
Previously reported findings demonstrated that a majority of brolucizumab 6 mg patients in the trials – 57% in HAWK and 52% in HARRIER – were maintained on a 12-week dosing interval following the loading phase through week 48. 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 wet AMD patients," said Glenn J. Jaffe, MD, chief of retinal ophthalmology at Duke University in Durham, North Carolina, and an author of the presentation in a news release. "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."
"HAWK and HARRIER previously demonstrated noninferiority in the primary endpoint of visual acuity and superiority in several secondary endpoints assessing key anatomical outcomes vs aflibercept, with a majority of brolucizumab patients maintained on an every-12-week dosing interval following the loading phase through week 481," said Dirk Sauer, Development Unit Head at Novartis Ophthalmology, in a news release. "Here we show that success early on with brolucizumab appears strongly predictive of the ability of these patients to successfully maintain this 12-week treatment interval through week 48. We look forward to continuing to advance brolucizumab through regulatory approvals as a welcome new option for treatment of nAMD, which is a leading cause of blindness."