FDA approves Eylea HD
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Key takeaways:
- Eylea HD was approved for patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.
- The approval was based on the pivotal PULSAR and PHOTON trials.
The FDA approved Eylea HD, an 8 mg aflibercept injection, to treat wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, according to a press release from Regeneron.
The approval was based on 48-week results from the pivotal PULSAR trial in wet AMD and PHOTON trial in DME, which compared Eylea HD 8 mg and Eylea 2 mg. Both trials met their primary endpoints, with Eylea HD showing noninferior and clinically equivalent vision gains with 12- and 16-week regimens after three initial monthly doses compared with an 8-week dosing regimen after initial monthly doses for Eylea. The majority of trial participants who were randomly assigned at baseline to Eylea HD 12- or 16-week dosing regimens maintained those dosing intervals through 48 weeks.
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The most common adverse reactions in those who received Eylea HD were cataract, conjunctival hemorrhage, increased IOP, ocular discomfort, eye pain, eye irritation, blurred vision, vitreous floaters or detachment, corneal epithelium defect and retinal hemorrhage.
“With Eylea HD, patients with wet age-related macular degeneration or diabetic retinal disease can now receive less frequent injections after their initial monthly doses and still experience the similar visual gains, anatomic improvements and safety profile of Eylea,” Peter K. Kaiser, MD, said in the release.
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