Eylea Hd

BLA 761355, held by Regeneron Pharmaceuticals. Aflibercept.

As of Nov 13, 2026, BLA 761355 (Eylea Hd), held by Regeneron Pharmaceuticals, was first approved by FDA on Aug 18, 2023, with 4 approved supplements and 1 published complete response letter.

First approved: Aug 18, 2023
Review: Priority
Supplements approved: 4
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Macular Edema Following Retinal Vein Occlusion (RVO) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 2, 2026	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 19, 2025	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 18, 2023	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Jun 27, 2023	Eylea HD (aflibercept)	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eylea Hd8MG(0.07ML;114.3MG/ML) · injectable;injection	Aflibercept	Rx

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 2, 2026	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 19, 2025	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 10, 2024	Supplement 6Labeling · Standard review	Approved	Label Letter
Dec 14, 2023	Supplement 1Labeling · Standard review	Approved	Label Letter
Aug 18, 2023	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Letter Label

Identifiers

Application: BLA 761355
Drugs@FDA: Overview at FDA
Company: Regeneron Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters