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The FDA approved Eylea HD for the treatment of macular edema following retinal vein occlusion, according to a press ...

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The FDA has approved Eylea HD (aflibercept) 8 mg to treat patients with macular edema following retinal vein occlusion (RVO) with dosing of up to every 8 weeks after an initial monthly dosing period.

The FDA also approved an every 4 week dosing regimen across all approved indications for patients who may not maintain a response on extended dosing intervals following successful initial treatment.

Analysts say the two new indications should help Eylea HD as Regeneron battles for market share with Roche’s Vabysmo.

FDA approves Regeneron's Eylea HD for retinal vein occlusion, adding extended dosing options and greater flexibility across ...

The nods allow Regeneron to better compete with Roche, which stormed the market in 2022 with Vabysmo. The Swiss drugmaker's ...

The approvals come as a pleasant surprise for Regeneron, analysts say, helping bolster the overall product profile of high-dose Eylea despite outstanding manufacturing concerns.

Regeneron has won two US Food and Drug Administration (FDA) approvals for Eylea HD (aflibercept), adding another indication ...