Regeneron Pharmaceuticals received a Complete Response Letter (CRL) from the FDA regarding its application to extend EYLEA HD’s dosing intervals beyond the currently approved 8-16 weeks. The FDA did not raise concerns about the drug’s safety or efficacy at its approved dosages but disagreed with the proposed extended dosing intervals. Regeneron is reviewing the FDA’s decision and will decide on next steps.
This CRL impacts Regeneron’s strategy to differentiate EYLEA HD through less frequent injections, a key selling point for patients seeking to reduce the burden of treatment for wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The inability to extend dosing intervals could limit EYLEA HD’s market competitiveness against rival therapies with similar efficacy and potentially less frequent dosing schedules. This setback also affects patients who could benefit from less frequent injections, reducing the inconvenience and potential discomfort associated with regular intravitreal injections.
The CRL specifically pertains to dosing intervals beyond 16 weeks. The FDA’s decision doesn’t affect the current approved dosing regimens for EYLEA HD, which remain at 8-16 weeks for wAMD and DME, and 8-12 weeks for DR, following initial monthly doses. Regeneron has not yet disclosed details of its interactions with the FDA or the specific data the agency found insufficient to support the extended dosing intervals.
This CRL presents a challenge for Regeneron. The company must now decide whether to conduct additional clinical trials to address the FDA’s concerns, potentially delaying wider adoption of EYLEA HD, or revise its marketing strategy to emphasize other benefits of the drug. The company’s response and the FDA’s subsequent actions will significantly influence the future market trajectory of EYLEA HD and Regeneron’s competitive positioning in the ophthalmology market.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
