The US FDA has approved the use of high dose Eylea (aflibercept) for three macular conditions, equating to longer intravitreal injection intervals for patients.
The treatment – commercial name Eylea HD injection 8mg – was approved by American regulators for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) on 18 August 2023.
The recommended dose is 8 mg (0.07 mL of 114.3 mg/mL solution) every four weeks (monthly) for the first three months across all indications, followed by 8 mg every eight to 16 weeks (two to four months) in nAMD and DME and every eight to 12 weeks (two to three months) for DR.
The anti-VEGF therapy’s manufacturer, Regeneron Pharmaceuticals, said it is now the first and only treatment approved in nAMD and DME for immediate dosing at eight-week and up to 16-week intervals following three initial monthly doses.
“The FDA approval of Eylea HD is an important advancement in retinal care,” said Dr Peter Kaiser, from the Cole Eye Institute and Professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine.
“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.”
Dr Allen Ho, director of retina research and co-director of the retina service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University, said the new treatment option builds off of the established efficacy and safety profile of Eylea.
“In its clinical trial program, Eylea HD demonstrated an unprecedented ability to maintain vision with extended dosing intervals, which created an exciting new advancement in the treatment of our patients with serious retinal diseases.”
The FDA approval is based on the 48-week results of PULSAR and PHOTON – two double-masked, active-controlled pivotal trials evaluating Eylea HD compared to Eylea injection 2 mg.
Both the PULSAR trial in nAMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with Eylea HD demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only three initial monthly doses, compared to an Eylea eight-week dosing regimen after initial monthly doses (three in PULSAR and five in PHOTON).
The vast majority of patients randomised at baseline to Eylea HD 12- or 16-week dosing regimens (following three initial monthly doses) could maintain these dosing intervals through 48 weeks.
The most common adverse reactions (≥3%) reported with Eylea HD were cataract, conjunctival hemorrhage, intraocular pressure increase, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
“More than 10 years ago, we fundamentally changed the way that certain serious retinal diseases were treated with the introduction of Eylea. With the approval of Eylea HD, we have elevated the high standard that Eylea set,” said Dr George Yancopoulos, board co-chair and president, and chief scientific officer at Regeneron, and a principal inventor of Eylea.
“Our continued commitment to retinal diseases resulted in an important scientific innovation – evolving the proven efficacy and safety of Eylea into a new treatment, Eylea HD, that provides lasting vision control with even fewer injections to further benefit those living with wet age-related macular degeneration or diabetic retinal diseases.”
Eylea HD is being jointly developed by Regeneron and Bayer AG. In the US, Regeneron maintains exclusive rights, while Bayer has licensed the exclusive marketing rights outside of the US, including Australia.
Regulatory filings for aflibercept 8 mg are under review in Europe and Japan. Submissions to other regulatory authorities in additional countries are also planned, a company statement said.
More reading
Vabysmo listed on PBS for first time
FDA approves Apellis’ SYFOVRE for first geographic atrophy treatment
Prof Robyn Guymer: Is Australia ready for the latest AMD therapies?
