Beovu's success in Kestrel is unlikely to fly in the real world

Novartis is now two for two with its pivotal trials of Beovu in diabetic macular oedema, following positive results from the Kestrel study. In the 571-patient trial a 6mg dose of the single-chain antibody fragment was non-inferior to 2mg of Regeneron/Bayer's Eylea in terms of baseline changes in best corrected visual acuity. The trial confirms the results seen in the Kite study, and also showed that Beovu could be used with a three-month dosing schedule. However, Novartis’s success here is unlikely to turn the tide on Beovu’s disappointing launch. The product, which is marketed for wet age-related macular degeneration, has been beset by serious safety concerns including severe intraocular inflammation and sight-threatening occlusive retinal vasculitis that has seen not only a revision to its label, but several class action lawsuits. Beovu’s side-effects have caused physicians to avoid the drug for safer options and sales forecasts to crash. Any chances of Novartis capturing market share are also likely to be further impacted by the patent expiry of Lucentis, expected next year, while the market is also bracing for Eylea biosimilars in 2024.