Aflibercept Leads to Sustained Improvements in Vision for Patients with Diabetic Macular Edema, Wet Age-Related Macular Degeneration

Aflibercept 8 mg demonstrated non-inferiority in vision gains in both the 12- and 16-week dosing regimens.

New data presented at the American Academy of Ophthalmology (AAO) show that aflibercept 8 mg produced sustained improvements in vision and anatomic measures of retinal fluid across a 48-week treatment period with both 12- and 16-week dosing regimens.

Aflibercept injection 2 mg is indicted for the treatment of patients with neovascular age-related macular degeneration (wAMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy. The PHOTON trial is investigating its use in DME and the PULSAR trial is investigating its use in wAMD.

DME is a common complication for individuals living with diabetes and occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can result in vision loss and, for some patients, blindness.

wAMD is a retinal disease that can affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, which can damage it and cause vision loss. An estimated 1.1 million individuals in the United States have wAMD, and this is expected to double by 2050.

“Our presentations at AAO demonstrate that aflibercept 8 mg 12- and 16-week dosing regimens have achieved a high bar, sustaining improvements in visual acuity and anatomic measures of retinal fluid across 48 weeks in patients with diabetic macular edema and wet age-related macular degeneration,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, in a press release.

The PHOTON and PULSAR trials both met the same primary endpoint. Aflibercept 8 mg demonstrated non-inferiority in vision gains in both the 12- and 16-week dosing regimens after initial monthly doses at 48 weeks compared to an 8-week dosing regimen with the brand-name Eylea, a 2-mg dose of aflibercept. Furthermore, 91% and 89% of DME patients and 77% of wAMD patients, respectively, randomized to 12- and 16-week dosing maintained those intervals through 48 weeks.

The safety of aflibercept 8 mg was similar to Eylea in both trials and was consistent with the known safety profile from previous clinical trials. Comparing aflibercept 8 mg to Eylea, ocular adverse events occurred in 31% versus 28%, respectively, in the PHOTON trial and 38% versus 39%, respectively, in the PULSAR trial. There were no cases of retinal vasculitis, occlusive retinitis, or endophthalmitis in either trial.

“These results were all achieved in patients who were rapidly initiated on extended dosing intervals with the vast majority not requiring regimen modification,” Yancopoulos said in the press release. “Altogether, the pivotal data support aflibercept 8 mg as providing a longer duration of action while maintaining a safety profile similar to Eylea.”

REFERENCE

Aflibercept 8 mg positive pivotal results in diabetic macular edema and wet age-related macular degeneration presented at AAO. News release. Regeneron; September 30, 2022. Accessed October 4, 2022. https://investor.regeneron.com/news-releases/news-release-details/aflibercept-8-mg-positive-pivotal-results-diabetic-macular-edema