Bayer Announces Phase III Clinical Trials of New Aflibercept 8 mg Formulation for Extended Dosing in Retinal Diseases

Bayer and Regeneron Pharmaceuticals, Inc. today announced the initiation of two planned Phase III studies—PHOTON and PULSAR—which will evaluate extended dosing intervals of intravitreal injections of the new 8 mg formulation of aflibercept in adult patients with vision impairment due to diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (wet AMD), respectively. Aflibercept intravitreal injection solution (2 mg), marketed under the brand name EYLEA®, has been approved for five indications in more than 100 countries. The two trials are scheduled to begin in 2020.

The rationale for the two trials was presented at the 2020 Angiogenesis, Exudation, and Degeneration (AED) Annual Meeting. The multicenter, randomized, double-blind trials will evaluate the efficacy and safety of aflibercept 8 mg in treatment regimens of 12 weeks (3 months) or longer.

Dr. Joerg Moeller, Member of the Executive Committee and Head of Research and Development at Bayer Pharmaceuticals Division, stated, “We have already observed that certain patients achieve favorable visual outcomes with aflibercept 2 mg when the dosing interval is extended to 16 weeks (4 months), particularly under the approved treat-and-extend regimens used in Europe and several other regions. The PHOTON and PULSAR trials will assess whether a broader patient population can benefit from the longer treatment intervals enabled by aflibercept 8 mg.”

Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of aflibercept. Regeneron holds exclusive rights to Eylea® in the United States, while Bayer holds the exclusive marketing license outside the United States. In markets excluding Japan, Bayer and Regeneron Pharmaceuticals, Inc. share equally in the sales profits of Eylea®; in Japan, Regeneron receives a percentage of net sales.

About VEGF and EYLEA® (aflibercept intravitreal injection solution)

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring cytokine in the human body. In healthy individuals, it promotes angiogenesis, thereby supporting the growth of tissues and organs. It is also associated with pathological intraocular neovascularization, increasing vascular permeability and leading to retinal edema.

Aflibercept for Injection is a recombinant fusion protein formed by fusing the extracellular domains of human vascular endothelial growth factor receptors 1 and 2 with the Fc domain of human IgG1, formulated as an isotonic solution for intravitreal injection. As a soluble decoy receptor, aflibercept binds to VEGF-A, VEGF-B, and placental growth factor (PlGF), thereby inhibiting the binding and activation of these factors with native VEGF receptors.

Aflibercept Intravitreal Injection Solution, marketed under the brand name Eylea®, has been approved for five adult indications in over 100 countries worldwide. It is primarily used to treat neovascular (wet) age-related macular degeneration (wet AMD) and other retinal diseases causing vision impairment, including retinal vein occlusion (RVO, encompassing both branch retinal vein occlusion [BRVO] and central retinal vein occlusion [CRVO]) and diabetic macular edema (DME). It is also approved for the treatment of vision impairment caused by myopic choroidal neovascularization (myopic CNV). Since its launch, global usage of Aflibercept Intravitreal Injection Solution has exceeded 30 million doses, representing an estimated patient exposure of more than 4 million patient-years.