An interim trial analysis of a phase 3 trial showed increased eye inflammation among patients who received the drug compared to patients who received aflibercept, a rival drug Regeneron and Bayer sell under the name Eylea. The analysis showed the rate of vision loss from any cause was 4.8 percent for patients who received Beovu, compared to 1.7 percent for patients who received Eylea.
Novartis announced early termination of three different trials testing the administration of Beovu every four weeks. The drug’s FDA label allows for dosing every eight to 12 weeks after three initial monthly loading doses.
Novartis said it communicated the data to health authorities and will seek a global update for Beovu’s prescribing information regarding four-week dosing.
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