Data from the aflibercept 8 mg clinical trial program will be presented at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting, April 23 to 27.
Recent findings on aflibercept (Eylea; Regeneron Pharmaceuticals, Inc.) injection and aflibercept 8 mg (Regeneron and Bayer AG) for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) will be discussed in 18 presentations at the ARVO 2023 annual meeting. The treatments are part of the aflibercept 8 mg clinical trial program to find safe and effective treatments for serious retinal diseases.
An estimated 1.1 million people in the United States have wAMD, a condition that occurs when abnormal blood vessels grow and leak fluid beneath the macula (responsible for sharp central vision and the ability to recognize fine details) which damages and scars the macula, causing possible vision loss.
Approximately 1.2 million of the 28 million US adults with diabetes has DME, a condition-related complication caused by high levels of blood sugar. Elevated blood sugar can damage the blood vessels in the eye, which will leak fluid into the macula and cause vision loss. More serious cases of DME can lead to blindness.
Some presentations will highlight subgroup data from the pivotaldouble-masked, active-controlled PULSAR and PHOTON trials, which are evaluating the safety and efficacy of wAMD and DME, respectively.
In PULSAR and PHOTON, patients were randomized to receive aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or aflibercept injection every 8 weeks. Patients on aflibercept 8 mg began with 3 monthly doses; those treated with injection received 3 initial monthly doses in PULSAR and 5 in PHOTON. In year 1, if patients in the aflibercept 8 mg arms of the trials experienced disease progression according to protocol-defined criteria, their dosing window could be reduced to 8 weeks. The aflibercept injection arm remained on a fixed 8-week schedule.
Aflibercept injection blocks 2 growth factors responsible in ocular angiogenesis; this prevents new blood vessel growth, thus lessens the chances for fluid to pass through the blood vessel and cause damage to the eye.
In February 2023, the FDA accepted for priority review the biologics license application for aflibercept 8 mg for the treatment of patients with wAMD, DME, and diabetic retinopathy with a target action date of June 27, 2023. Currently, aflibercept 8 mg remains investigational, as its safety and efficacy have not yet been fully evaluated by a regulatory authority.
AFLIBERCEPT 8 MG AND EYLEA® (AFLIBERCEPT) INJECTION PRESENTATIONS AT ARVO PROVIDE NEW INSIGHTS INTO THE TREATMENT OF SERIOUS RETINAL DISEASES. Regeneron. April 17, 2023. Accessed on April 17, 2023. https://investor.regeneron.com/news-releases/news-release-details/aflibercept-8-mg-and-eylear-aflibercept-injection-presentations