Regeneron jumps 16% as pivotal trials for less frequent Eylea reach main goals
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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).
After a brief trading halt ahead of the news release, REGN shares jumped ~16% in reaction.
Eylea injection of 2 mg is already indicated in the U.S. for conditions including DME and 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.
91% and 89% of DME patients and 79% and 77% of WAMD patients remained on 12- and 16-week dosing intervals without dose modifications through week 48, respectively.
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-FranÃ§ois 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.
In 2021, full-year Eylea net sales rose 17% YoY to $5.8B in the U.S.