In August, regulators in the US approved the higher dose version of Eylea, which is co-developed with Regeneron Pharmaceuticals, after clearance had initially been denied in June. Regeneron reported recently that the high-dose version generated in $43 million in the third-quarter quarter, ahead of analyst expectations, with the pace of switches from the regular-dose product described as "encouraging." For more, see Spotlight On: Early evidence that Eylea could strike back against Vabysmo.
The endorsement by the EMA's Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the Phase III PULSAR trial in wet AMDAMD and the Phase II/III PHOTON trial in DME. Both met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes at week 48 with Eylea 8mg given as 12- or 16-week dosing regimens, compared to Eylea 2mg given as a fixed 8-week treatment interval.
"This positive CHMP opinion underscores the potential of [Eylea] 8mg to set a new benchmark for the treatment of these progressive blinding diseases," said Bayer's R&D head Christian Rommel.
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