Regeneron Pharmaceuticals Inc. (REGN), a biotechnology company, announced on Tuesday that its phase III QUASAR trial evaluating Eylea HD for the treatment of patients with macular edema following retinal vein occlusion has met its primary endpoint.
In the QUASAR trial, the efficacy and safety of Eylea HD were compared to Eylea in treatment-naïve patients with macular edema secondary to retinal vein occlusion including central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO) and hemiretinal vein occlusion.
Eylea HD and Eylea, which are administered by injection into the eye, contain the same ingredient Aflibercept. Eylea HD is an 8 mg dose formulation of Aflibercept while Eylea is a 2mg dose formulation of Aflibercept.
According to the trial findings reported today, Eylea HD demonstrated non-inferior vision gains with an every 8-week dosing regimen compared to Eylea dosed every 4 weeks. Eylea HD was well tolerated in the QUASAR trial, and its safety profile was consistent with previous clinical trials.
Commenting on the QUASAR trial results, Seenu Hariprasad, Chair of the Department of Ophthalmology and Visual Science at the University of Chicago, said, "All currently FDA-approved anti-VEGF therapies for retinal vein occlusion require monthly dosing, which can be burdensome for a patient. These impressive data from QUASAR demonstrated that EYLEA HD patients with retinal vein occlusion experienced improved vision with fewer injections than EYLEA - which could offer a significant advancement in this treatment setting."
Based on the positive results, the company plans to seek FDA approval for Eylea HD in the expanded use in treating retinal vein occlusion in the first quarter of 2025.
Eylea HD, which received its initial FDA approval in August 2023, is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Eylea, which received its initial FDA approval in November 2011, is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity.
Eylea HD is being jointly developed by Regeneron and Bayer AG. In the U.S., Regeneron holds exclusive rights to Eylea and Eylea HD. Bayer has licensed the exclusive marketing rights outside of the U.S., where the profits from sales of Eylea and Eylea HD are shared equally by the two companies.
In the third quarter of 2024, the U.S. net sales for Eylea and Eylea HD totaled $1.54 billion, reflecting a 3% increase compared to the same period last year. Of this amount, Eylea HD generated $392 million in U.S. net sales.
REGN is currently trading at $740.08, up 2.10%.
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