Study: Eylea HD Achieves Key Milestone in Wet AMD and DME Treatment
Regeneron Pharmaceuticals announced that The Lancet has published the one-year results of the pivotal PULSAR and PHOTON trials. These results highlight that Eylea HD (aflibercept injection 8 mg) extended dosing regimens are non-inferior to the standard Eylea aflibercept injection (2 mg) in treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
PULSAR and PHOTON Trials
The PULSAR and PHOTON trials, both double-masked, active-controlled studies, assessed the efficacy of Eylea HD in comparison to Eylea across a cohort of 1,009 patients with wet AMD and 658 patients with DME, respectively. Eylea HD demonstrated noninferior and clinically equivalent vision gains at 48 weeks, following 12- and 16-week dosing regimens after only three initial monthly doses. This is in comparison to Eylea's 8-week dosing regimen after the initial monthly doses. A significant proportion of patients, 79% and 77% with wet AMD and 91% and 89% with DME, managed to maintain these extended dosing intervals through 48 weeks.
Adverse reactions reported in patients treated with Eylea HD 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.
Expert Opinions and Clinical Insights
David M. Brown, MD, FACS, Director of Research at Retina Consultants of Texas and an investigator in the trials, expressed his enthusiasm for the achievement. “The publication of 48-week results from PULSAR and PHOTON in The Lancet are a recognition of the important advancement Eylea HD has made in retinal care,” he said. Brown highlighted the impact of Eylea HD on managing difficult cases of diabetic eye disease and its ability to offer less frequent dosing schedules without compromising safety.
In August 2023, the U.S. Food and Drug Administration (FDA) approved Eylea HD for the treatment of wet AMD, DME, and diabetic retinopathy (DR), following the encouraging one-year data from these trials. Further data presented at the EURETINA Congress and the American Society of Retina Specialists annual meeting in 2023 have also supported the continued development and application of Eylea HD.
Eylea HD is a collaborative effort between Regeneron and Bayer AG. In the United States, Regeneron holds exclusive rights to Eylea and Eylea HD. Outside the U.S., Bayer has exclusive marketing rights, with profits from sales of Eylea and Eylea HD (known as Eylea 8 mg outside the U.S.) being shared equally between the companies. Eylea 8 mg has received approval in the European Union, Japan, and several other countries, with further regulatory submissions made in additional nations.
About Wet AMD and Diabetic Macular Edema
Wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) are two prevalent conditions that can significantly impair vision. Wet AMD, a chronic eye disorder, arises when abnormal blood vessels grow under the retina and leak fluid, leading to rapid and severe vision loss if untreated. It's a progression from the less severe dry AMD, distinguished by the growth of these leaky vessels.
DME occurs as a complication of diabetic retinopathy, diabetes-induced damage to the blood vessels of the retina, where fluid accumulates in the macula—the part of the eye responsible for sharp, straight-ahead vision—causing swelling and blurred vision. Both conditions share the common threat of leading to central vision loss, which is crucial for activities like reading, driving, and recognizing faces. Advances in treatment, such as anti-VEGF injections, have significantly improved outcomes, allowing many patients to maintain or regain vision.
