Studies with the Beovu 6 mg strength met the primary endpoint, but a significant number of intraocular inflammation was also observed.
Novartis prematurely stopped several studies with the eye medicine Beovu. High rates of intraocular inflammation were seen in the treatment compared to the comparison therapy, the Basel group said on Friday evening. The data has been transmitted to the health authorities.
Phase III “Merlin” with a Beovu 6 mg strength met the primary endpoint, Novartis said. But there has also been a significant number of intraocular inflammation including reticular vasculitis and retinal vascular occlusions. There was also a higher rate of vision loss than with the comparison therapy.
Novartis also evaluated other clinical programs with the active substance brolucizumab and decided, in addition to the “Merlin” study, to terminate the “Raptor” and “Raven” studies. These studies looked at the efficacy and safety of the drug in cases of retinal vein occlusion. Health authorities have been notified and Novartis will complete the package inserts for Beovu globally. Further data on the “Merlin” study will be presented at a later date.
Beovu (brolucizumab) is approved in over 60 countries for the treatment of age-related macular degeneration. The drug is being tested further for the treatment of other eye diseases.