Regeneron receives FDA approval for EYLEA HD

Regeneron receives FDA approval for EYLEA HD

The Food and Drug Administraton (FDA) gave approval after two active-controlled, double-masked pivotal trials, which compared EYLEA HD to EYLEA over a 48 week period.

Patients suffering from wet age-related macular degeneration (wAMD), diabetic retinopathy (DR) and diabetic macular edema (DME) now have another treatment option with the recent FDA approval of EYLEA HD.

The Food and Drug Administraton (FDA) gave approval after two active-controlled, double-masked pivotal trials, which compared EYLEA HD to EYLEA over a 48 week period. Results showed that participants receiving the EYLEA HD had non-inferior and clinically equivalent vision gains compared to the EYLEA subjects.

The most commonly reported adverse reactions for the EYLEA HD were increased intraocular pressure, conjuntival hemorrhage and cataracts. EYLEA HD is administered in 8 mg injections versus the 2 mg injection of EYLEA. The benefit of the EYLEA HD is that it provides lasting vision control with fewer injections. EYLEA HD will be available immediately with patients being able to order the drug early this week. The cost will be $2,625 per dose.

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