Novartis AG (NYSE:NVS; SIX:NOVN) has announced additional data form their Phase III HAWK and HARRIER trials of brolucizumab (RTH258) for the treatment of wet AMD. The most recent data shows an improved advantage for the Novartis drug over the competing Eylea treatment from Regeneron Pharmaceuticals Inc. The Novartis sponsored research reported that 6 mg brolucizumab was superior to Eylea in reducing retinal fluid and thickness, both of which were secondary endpoints in the Phase III studies. According to Novartis, active disease was observed in 23.5% of brolucizumab patients, versus 33.5% of Eylea patients at 16 weeks, while a second similar study found active disease in 21.9% of RTH258 patients versus 31.4% of those on Eylea. In addition, data suggested an additional advantage from the HAWK and HARRIER studies in that more than half of patients on brolucizumab remained on a 12-week dosing schedule, compared to Eylea’s label recommending dosing every 8 weeks. Brolucizumab is a humanized single chain anti-body fragment (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms. According to Novartis, potential benefits of the small size include better tissue penetration and rapid clearance from the systemic circulation.
It is understood that Novartis plans to submit a regulatory publication to both the FDA and EMA in 2018, which will undoubtedly heighten competition in the existing anti-VEGF market for neovascular AMD treatment. In the original Phase III studies of brolucizumab, over 1,800 patients with nAMD were enrtolled across 400 centers worldwide. The primary and secondary endpoints were non-inferiority of the drug to aflibercept (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 endpoints were met with significant p values and both trials were generally well tolerated with overall ocular and non-ocular (systemic) adverse event rates, comparable to Eylea. In addition, a majority of patients, 57% (HAWK) and 52% (HARRIER), were maintained exclusively on a 12-week treatment interval following the loading phase through week 48.
Commenting on the achievement, Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis stated, “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. Based on these robust data, we are looking forward to working with regulatory agencies to bring this pioneering treatment to patients.”