RTH258 for wet age-related macular degeneration, met its primary and key secondary endpoints in two phase 3 studies, according to a Novartis press release.
The HAWK and HARRIER trials studied the non-inferiority of RTH258 (brolucizumab, 6 mg) vs. Eylea (aflibercept, Regeneron) in regards to change in best corrected visual acuity from baseline to week 48 and average mean change between week 36 and week 48. These endpoints were met with significant P values.
The 96-week prospective, randomized, double-masked trials enrolled more than 1,800 patients in 400 worldwide centers.
RTH258, a single-chain antibody fragment VEGF inhibitor, also showed long-lasting efficacy dosed every 8 weeks compared with aflibercept, and a majority of the patients were maintained in a 12-week interval through week 48 after the loading phase, according to the release.
“These results clearly and convincingly demonstrate RTH258 has the potential to reduce injection burden while providing excellent visual outcomes,” Vas Narasimhan, Novartis global head of drug development and chief medical officer, said in the release.
The company plans to begin working with regulatory agencies based on the trial data, Narasimhan said in the release.