Novartis has decided to terminate the two-year Phase III MERLIN clinical trial of Beovu (brolucizumab) in wet age-related macular degeneration (AMD) patients despite meeting the primary endpoint.
Wet AMD develops due to the growth of abnormal blood vessels below the macula, which regulates sharp, central vision. The disease is known to cause severe vision loss and legal blindness.
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Beovu holds approval in more than 60 countries to treat patients suffering from wet AMD.
When compared to aflibercept 2mg, Novartis’ drug given at 6mg dose every four weeks met the Phase III trial’s primary endpoint of non-inferiority in change from baseline in best corrected visual acuity.
The trial included patients with retinal fluid that persisted even after anti-vascular endothelial growth factor (VEGF) treatment.
According to the first interpretable one-year data from the trial, the drug also showed superiority on certain anatomical secondary endpoints at year one when administered every four weeks after the loading phase.
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By GlobalDataNovartis added that Beovu, however, led to higher IOI, including retinal vasculitis and retinal vascular occlusion versus aflibercept 2mg.
The overall rate of vision loss related to all causes was 4.8% in patients treated with Novartis’ drug compared to 1.7% with aflibercept.
In this context and for patient safety, the company decided to discontinue the MERLIN trial.
Novartis chief medical officer and Drug Development global head John Tsai said: “Although longer dosing intervals may benefit many people living with wet AMD and other retinal diseases, some are in need of monthly dosing to address persistent fluid.
“We initiated MERLIN and other clinical programmes to explore Beovu for these patients. These data help inform our trials moving forward, so we can best determine how appropriate patients can benefit most from this important medicine.”
The company reviewed all ongoing clinical programmes of brolucizumab given in four-week dosing intervals following the loading phase.
Based on the data, Novartis will also terminate RAPTOR and RAVEN trials, which evaluated the efficacy and safety of the drug’s six initial monthly injections in retinal vein occlusion.
It will update all additional relevant ongoing study protocols to stop the use of four-week dosing intervals following the loading phase.
Beovu 6mg should not be given at intervals less than two months beyond the initial three doses, the company noted.
Earlier this month, Novartis reported that its Beovu met primary endpoints in Phase III KESTREL and KITE trials involving diabetic macular oedema (DME) patients.
