Brolucizumab compares well with Eylea in Phase III study

21 June 2017

Novartis (NOVN: VX) has reported that RTH258 (brolucizumab) 6mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER.

RTH258 3mg, evaluated in HAWK, also met these endpoints. These pivotal studies enrolled more than 1,800 patients with neovascular age-related macular degeneration (nAMD) across 400 centers worldwide, the Swiss pharma giant noted.

The primary and key secondary efficacy endpoints were non-inferiority of RTH258 to aflibercept – Bayer (BAYN: DE) and Regeneron’s (Nasdaq: REGN) Eylea - in mean change in best-corrected visual acuity (BCVA) 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. RTH258 was generally well tolerated with overall ocular and non-ocular (systemic) adverse event rates comparable to aflibercept.

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