- Regeneron ( NASDAQ: REGN ) announced Thursday that its blockbuster eye medication Eylea reached the primary endpoints in two pivotal trials designed to investigate a less frequent dosing regimen in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD).
- The PHOTON trial in DME and the PULSAR trial in wAMD indicated that Eylea, identified as aflibercept in generic terms, achieved non-inferiority in vision gains with 8 mg 12- and 16-week dosing regimens compared to EYLEA 8-week dosing regimen.
- The company said the safety profile of the novel aflibercept regimen was consistent with that of the FDA-approved Eylea.
- "These outcomes have shown that aflibercept 8 mg not only improved vision with less frequent injections, but also demonstrated a similar safety profile to EYLEA," remarked Jean-François Korobelnik, Professor of Ophthalmology and a trial investigator.
- REGN and its partner for 8 mg aflibercept German pharma company Bayer AG ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) plan to submit the data to global regulatory authorities.
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Regeneron says pivotal trials for less frequent Eylea injections reached main goals