On August 18, 2023, Regeneron Pharmaceuticals announced a groundbreaking development in the field of ophthalmology: the US Food and Drug Administration (FDA) has granted approval for Eylea HD (aflibercept) Injection 8 mg. This newly approved treatment offers hope to patients dealing with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The FDA’s decision is founded on the impressive 48-week outcomes from two pivotal trials, PULSAR and PHOTON.
Eylea HD ushers in a novel dosing regimen that signifies a notable shift in treatment dynamics. Patients are administered 8 mg (0.07 mL of 114.3 mg/mL solution) every four weeks for the first three months across all three indications. Subsequently, the dosing frequency varies: for wAMD and DME, it’s every 8 to 16 weeks, and for DR, every 8 to 12 weeks.
Following the announcement, Regeneron’s stock price experienced a 4% increase, rising from $794 on Friday afternoon to $826 by mid-morning on Monday.
Regeneron, in partnership with Bayer for Eylea, is gearing up for a competitive showdown with Roche and its rapidly ascending high-dose treatment, Vabysmo. Impressively, Vabysmo has achieved blockbuster status within just 19 months of being on the market.
Regeneron is poised to introduce its high-dose Eylea at a price of $2,625 per dose. In comparison, a vial of Vabysmo, which carries a 6 mg dose, is priced at $2,316. This strategic pricing move sets the stage for an intriguing market dynamic, as both treatments vie for prominence.
The launch of high-dose Eylea is imminent, with customers granted the opportunity to place orders “early this week,” according to a communication from a Regeneron spokesperson. This swift action underscores Regeneron’s commitment to delivering innovative treatments to the market promptly.
Related: Regeneron’s High-Dose Eylea Demonstrates Persistence As FDA Decision Looms
The crux of this approval lies in the impressive results from the PULSAR and PHOTON trials. These double-masked, active-controlled studies evaluated Eylea HD against Eylea Injection 2 mg. Notably, both the PULSAR trial focused on wAMD (N=1,009) and the PHOTON trial on DME (N=658) met their primary endpoints. Eylea HD demonstrated non-inferior and clinically equivalent vision gains at 48 weeks, achieved through both 12- and 16-week dosing regimens following just three initial monthly doses. This performance was compared to an Eylea 8-week dosing regimen after the initial monthly doses (3 in PULSAR and 5 in PHOTON). An encouraging finding was that most patients assigned to Eylea HD 12- or 16-week dosing schedules were able to maintain these intervals for the full 48 weeks.
“The FDA approval of EYLEA HD 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.”
– Peter Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and Professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine
Adverse reactions, though infrequent, included cataract, conjunctival hemorrhage, increased intraocular pressure, ocular discomfort, eye pain, eye irritation, blurred vision, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
Eylea HD is a collaborative effort between Regeneron and Bayer AG. While Regeneron holds exclusive rights to Eylea and Eylea HD in the US, Bayer has secured exclusive marketing rights for territories outside the US, with profits being evenly shared post-regulatory approvals.
“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. 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.”
– Allen C. Ho M.D., Director of Retina Research and Co-Director of the Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University
The global impact of this advancement is substantial. Regulatory assessments for aflibercept 8 mg are currently underway in Europe and Japan, with further submissions planned for other countries.
The PULSAR and PHOTON trials, which span various centers globally, showcased the efficacy of Eylea HD’s dosing regimens. Patients received initial monthly doses followed by a flexible dosing schedule, reflecting the adaptability of this treatment approach. These trials, led by Bayer and Regeneron, have presented their one-year and top-line two-year results in 2022 and 2023, respectively, marking pivotal milestones in the pursuit of improved eye care solutions.
While Vabysmo has been gaining momentum, achieving sales of 957 million Swiss francs (equivalent to $1.1 billion) in the initial half of this year, Eylea’s sales growth has hit a plateau. Eylea’s second-quarter revenue of $1.5 billion remained consistent with the previous quarter’s results but represented a 7% decrease compared to the same timeframe in 2022.
