According to Regeneron, the approval was based on data in the PULSAR and PHOTON trials, in which the drug demonstrated clinically equivalent vision gains to aflibercept Injection 2 mg that were maintained with fewer injections.
Regeneron Pharmaceuticals Inc. announced that the United States Food and Drug Administration (FDA) has approved aflibercept injection 8 mg (EYLEA HD) for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR).
According to the company, the recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR.
Peter Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and a professor of ophthalmology at Cleveland Clinic Lerner College of Medicine, in Cleveland, Ohio, said in the news release, the FDA approval of aflibercept injection 8 mg is “an important advancement in retinal care.”
“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,” Kaiser said.
Allen C. Ho MD, the director of Retina Research and co-director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University, applauded the approval.
“I look forward to offering EYLEA HD to my patients as a new treatment option that builds off of the established efficacy and safety profile of EYLEA,” he said in the news release. “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.”
According to the news release, the 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 (aflibercept) Injection 2 mg. Both the PULSAR trial in wet AMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with aflibercept injection 8 mg demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an EYLEA 8-week dosing regimen after initial monthly doses (3 in PULSAR and 5 in PHOTON).
Regeneron noted in the news release that the vast majority of patients randomly assigned at baseline to aflibercept injection 8 mg 12- or 16-week dosing regimens (following 3 initial monthly doses) were able to maintain these dosing intervals through 48 weeks.
The most common adverse reactions (≥3%) reported in patients treated with EYLEA HD were cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
Aflibercept 8 mg clinical trial program
The company recently noted in a news release that PULSAR in wet AMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or EYLEA every 8 weeks. The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON
Moreover, the company noted that patients treated with aflibercept 8 mg in both trials had 3 initial monthly doses, and patients treated with Eylea received 3 initial doses in PULSAR and 5 in PHOTON. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for disease progression were observed. Intervals could not be extended until the second year of the study. Patients in all groups maintained a fixed 8-week dosing regimen throughout their participation in the trials.
George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of the drug, said it has shifted the treatment paradigm for the treatment of serious retinal diseases.
“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,” he said in the release.
According to the news release, aflibercept injection is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron maintains exclusive rights to both aflibercept injection 2 mg and aflibercept injection 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of of both options pending any regulatory approvals.
Regulatory filings for aflibercept 8 mg are under review in Europe and Japan. Submissions to other regulatory authorities in additional countries are also planned.