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EYLEA HD is anticipated to gain traction with the launch of a prefilled syringe in mid-2025 and label expansions for macular edema and extended dosing intervals.
Regeneron's phase III study evaluating Eylea HD against stand-of-care Eylea treatment meets the primary endpoint of non-inferior visual gain in RVO patients.
EYLEA HD (known as Eylea™ 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG.
We may or may not be out of the woods, but focusing on the short-term performance of stocks is not the best strategy.
Regeneron (REGN) announces FDA review of sBLA for Eylea HD to treat macular edema and expand dosing. Read more here.
Investors' focus is likely to be on the performance of Dupixent and the uptake of Eylea HD when REGN reports first-quarter results on April 29.
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application Provided by GlobeNewswire Apr 18, 2025, 12:00:22 PM ...
The FDA disagreed with Regeneron’s proposal to add additional extended dosage intervals of greater than every 16 weeks, which is the maximum dosing interval on the currently approved label.
Furthermore, Eylea HD could potentially earn label expansions, helping to mitigate Eylea-related losses. Meanwhile, Regeneron's other main growth driver, eczema treatment Dupixent, is still ...
EYLEA HD is anticipated to gain traction with the launch of a prefilled syringe in mid-2025 and label expansions for macular edema and extended dosing intervals.