Novartis receives positive news in eye drug P3 studies
pharmafile | June 20, 2017 | News story | Manufacturing and Production, Research and Development | Eylea, Novartis, Regeneron
Novartis has achieved positive feedback from its two Phase 3 studies into its eye drug RTH258 (brolucizumab), which found it as effective as its nearest rival but needing fewer doses. The drug, if approved by the FDA, will be used in the treatment of neocascular age-related macular degeneration (nAMD).
The news caused the company’s shares to rise, as it now stands to gain ground in an area of treatment with a high number of patients – approximately 25 million. Novartis stands to gain ground from Regeneron’s treatment Eylea – a leader in the market for the last six years but now facing threats from different angles.
Novartis’ treatment stands to be one of those keen to take Eylea’s market share after two trials hit both primary and secondary endpoints. The primary endpoint was non-inferiority of RTH258 to Eylea (aflibercept) in mean change in best-corrected visual acuity and average mean change over the period between the weeks 36 to 48.
Both of these were successfully matched and RTH258 was able to demonstrate efficacy in a 12-week regimen, versus the 8-week dosage in Eylea. The option of having a longer-lasting medication obviously has a clear advantage when it comes to sales, potentially allowing it to perform the same time-dependent leapfrog that Eylea managed against Roche and Novartis’ Lucentis.
“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. “Based on these robust data, we are looking forward to working with regulatory agencies to bring this pioneering treatment to patients.”
Full data from the studies are not yet released, with this expected to be released at an upcoming medical congress.
Ben Hargreaves
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