Novartis has reported positive results from the Hawk and HARRIER trials, two Phase III studies designed to compare the efficacy and safety of brolucizumab against aflibercept to treat patients with neovascular age-related macular degeneration (nAMD), a leading cause of blindness.
The results were derived from a pre-specified secondary analysis of both trials, which enrolled more than 1,800 patients across 400 centres worldwide.
The data revealed that patients deemed 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.
It also showed that patients who received 6mg of brolucizumab were suitable for 12-week treatment intervals during the first cycle after the loading phase had an 87% and 83% probability in HAWK and HARRIER trials, respectively, of remaining on this quarterly treatment interval through week 48.
This outcome could help physicians and patients better manage, personalise and optimise treatment plans.
Novartis Ophthalmology Development Unit head Dirk Sauer said: “HAWK and HARRIER previously demonstrated non-inferiority in the primary endpoint of visual acuity and superiority in several secondary endpoints assessing key anatomical outcomes versus aflibercept, with a majority of brolucizumab patients maintained on an every-12-week dosing interval following the loading phase through week 48.
“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.”
In addition, both trials compared the safety of brolucizumab and aflibercept with the overall incidence of adverse events balanced across all treatment groups.
The most frequently reported ocular adverse events were reduced visual acuity, conjunctival hemorrhage, vitreous floaters and eye pain, while non-ocular adverse events were similar to those reported in an AMD population.
No notable differences were reported between the treatment arms.