Regeneron and Bayer Achieve Phase III Success with High-Dose Eylea for Retinal Vein Occlusion, Paving Way for Label Expansion

Phase III Success:
Regeneron and Bayer announced that high-dose Eylea (Eylea HD) met its primary endpoint in the Phase III QUASAR trial for treating macular edema following retinal vein occlusion (RVO)14.

Dosing Regimen:
Eylea HD, administered every 8 weeks after initial monthly doses, demonstrated non-inferior vision gains compared to the standard monthly dosing regimen of Eylea 2 mg45.

Market Expansion:
This success could lead to a label expansion for Eylea HD, potentially reducing the treatment burden for RVO patients and boosting sales amidst biosimilar competition14.

Regulatory Submission:
Regeneron plans to submit a supplementary biologics license application to the FDA in Q1 202545.

Biosimilar Pressure:
The move comes as Regeneron faces declining Eylea sales due to biosimilar encroachment, with several Eylea copycats approved by the FDA in recent months13.

Clinical Significance:
RVO is a common cause of vision loss in adults, and the extended dosing regimen of Eylea HD could offer a significant advancement in this treatment setting5.

Sources:

1. https://www.biospace.com/drug-development/regeneron-bayer-build-retinal-vein-occlusion-case-for-eylea-as-biosimilar-pressure-mounts

3. https://www.prnewswire.com/news-releases/eylea-aflibercept-injection-receives-fda-approval-for-macular-edema-following-retinal-vein-occlusion-rvo-278287631.html

4. https://www.stocktitan.net/news/REGN/eylea-hd-aflibercept-injection-8-mg-phase-3-trial-meets-primary-psuy1ick6wbe.html

5. https://newsroom.regeneron.com/news-releases/news-release-details/eylea-hdr-aflibercept-injection-8-mg-phase-3-trial-meets-primary