Novartis’ eye drug brolucizumab has been proven in trials to be non-inferior to Regeneron/Bayer’s Elyea in treating vision loss in patients with neovascular age-related macular degeneration (nAMD), but with fewer injections than its rival.
RTH258 (brolucizumab) 6mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER, of non-inferiority Eylea (aflibercept) in mean change in best-corrected visual acuity from baseline to week 48, and average mean change over the period of week 36-48, respectively.
Both were met with “highly significant p values,” the firm noted, also adding that its drug was found to be generally well tolerated.
Moreover, RTH258 demonstrated “long-lasting efficacy” versus Eylea dosed every eight weeks, with the majority of patients 57 percent (HAWK) and 52 percent (HARRIER), maintained exclusively on a 12-week dosing interval immediately following the loading phase through week 48.
"These results clearly and convincingly demonstrate RTH258 has the potential to reduce injection burden while providing excellent visual outcomes,” said Narasimhan, global head of drug development and chief medical officer at Novartis.
"Based on these robust data, we are looking forward to working with regulatory agencies to bring this pioneering treatment to patients."
Detailed analysis of the data is ongoing and will be presented at an upcoming medical congress.