Novartis' brolucizumab matches Eylea with less frequent dosing in AMD studies

Novartis announced Tuesday that the experimental drug brolucizumab, also known as RTH258, met the main goal of two late-stage studies in patients with neovascular age-related macular degeneration (AMD), demonstrating non-inferiority to Regeneron Pharmaceuticals' Eylea (aflibercept). "These results clearly and convincingly demonstrate RTH258 has the potential to reduce injection burden while providing excellent visual outcomes," remarked Vas Narasimhan, chief medical officer at Novartis.

The HAWK and HARRIER trials randomised more than 1800 patients with neovascular AMD to receive Eyela every eight weeks or brolucizumab at one of two doses. Novartis noted that after a three-month loading phase, patients in the brolucizumab arm received a 12-week dosing interval with an option to adjust to an eight-week dosing interval. The Swiss drugmaker indicated that 57 percent of patients given the higher dose of brolucizumab in the HAWK study and 52 percent of subjects in the HARRIER trial were maintained exclusively on an every 12-week dosing interval immediately following the loading phase through week 48.

FirstWord reports in this therapy area - KOL Insight AMD: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.

The primary efficacy objective of the trials was to confirm that brolucizumab is non-inferior to Eylea in mean change in best-corrected visual acuity (BCVA) from baseline to week 48. Meanwhile, secondary goals include average mean change in BCVA from baseline over the period week 36 to week 48, the proportion of patients on an every 12 week dosing interval at week 48 and anatomical parameters.

According to Novartis, brolucizumab was generally well tolerated with overall ocular and non-ocular adverse event rates comparable to Eylea. The Swiss company noted that detailed analysis of the data is ongoing and will be presented at an upcoming medical congress, adding that regulatory filings for the therapy are planned for 2018.

Commenting on the results, Jefferies analysts called the less frequent dosing of Novartis' drug "a significant differentiator and competitive advantage." For further analysis, read ViewPoints: Novartis passes important test in bid to dethrone Regeneron's Eylea.

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