Novartis confirms macular degeneration treatments with 1800 patients globally, production filing in 2018

The Swiss-based world’s Ophtamology leader Novartis has reported that RTH258 (brolucizumab) 6 mg met the primary and key secondary endpoints in two Phase III studies, HAWK and HARRIER, with RTH258 3 mg, evaluated in HAWK, also met these endpoints.

Novartis on Tuesday said that these pivotal studies enrolled more than 1,800 patients with neovascular age-related macular degeneration (nAMD) across 400 centers worldwide. The primary and key secondary efficacy endpoints were non-inferiority of RTH258 to aflibercept in mean change in best-corrected visual acuity (BCVA). 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, the Swiss company pointed out.

RTH258 demonstrated long-lasting efficacy versus aflibercept dosed every eight weeks. A majority of patients, 57% (HAWK) and 52% (HARRIER), were maintained exclusively on a q12w (every 12 week) 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.  Given our legacy in developing medicines to preserve vision, we are pleased that RTH258 carries the promise of being the next major advancement for patients with nAMD” said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis.

Low cost of goods formulation

Novartis will present the detailed analysis of the data at an upcoming medical congress. Given the complexity of the formulation, Novartis said it has invested to ensure a competitive, low cost of goods formulation over the past 18 months to maximize the long term value of RTH258. Novartis said it expects to complete the pharmacokinetic study with the final manufacturing process to enable filing in 2018.