FDA approves Eylea HD for macular edema after retinal vein occlusion

• The decision is supported by positive visual acuity gains found in the phase 3 QUASAR trial.
• This is the fourth approved indication for Eylea HD.

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

Eylea HD (aflibercept 8 mg, Regeneron) is now indicated for treating retinal vein occlusion (RVO) with dosing intervals of up to every 8 weeks after an initial monthly dosing period.

This recent approval also allows for monthly dosing for RVO as well as the previously approved indications of wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy “for some patients who may benefit from resuming this dosing schedule,” according to the press release from Regeneron.

The decision is supported by positive data from the phase 3 QUASAR trial, in which Eylea HD achieved the study’s primary endpoint of visual acuity gains that were noninferior to those yielded by Eylea (aflibercept 2 mg) at 36 weeks when delivered at a dosing regimen of every 4 weeks, as Healio previously reported.

Read more:https://shorturl.at/3wXLU

Source: Healio

Perspective by David A. Eichenbaum, MD, FASRS

The FDA approved Eylea HD for every-4-week dosing across all label indications this week based on data from the ELARA neovascular AMD monthly dosing trial and QUASAR retinal vein occlusion with macular edema trial. This is a tremendous change in the label for Eylea HD. The PULSAR and PHOTON registration trials for Eylea HD were designed to demonstrate the potential durability of aflibercept 8 mg, and they successfully achieved that. However, in the real world, many clinicians treat a dry macula, and neither PULSAR nor PHOTON prioritized dry anatomy in the pursuit of long extension. Although aflibercept is a potent drying agent, there are some patients who require dosing more frequently than every 8 weeks to achieve dry anatomy, even with the fourfold higher aflibercept dose in Eylea HD.

Every-4-week dosing unlocks the flexibility in the Eylea HD product that will allow prescribers to use this agent on their more challenging exudative macular disease patients. I am encouraged by the monthly dosing data presented from ELARA and QUASAR, and I am eager to see how Eylea HD performs with more frequent dosing in the real world.