BASEL (dpa-AFX) - Novartis (NVS) reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER. RTH258 3 mg, evaluated in HAWK, also met these endpoints. The primary and key secondary efficacy endpoints were non-inferiority of RTH258 to 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. RTH258 was generally well tolerated with overall ocular and non-ocular adverse event rates comparable to aflibercept.
Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis, stated: 'Based on these robust data, we are looking forward to working with regulatory agencies to bring this pioneering treatment to patients.'
Novartis expects to complete the pharmacokinetic study with the final manufacturing process to enable filing in 2018.
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