Introduction to EYLEA Drug Industry
Eylea (aflibercept) is a vascular endothelial growth factor (VEGF) inhibitor developed by Regeneron Pharmaceuticals and Bayer that has received regulatory approval around the world for the treatment of various eye conditions. It works by blocking VEGF, a protein that promotes the growth of abnormal blood vessels in the eye. By inhibiting VEGF, Eylea is able to help control the formation of new blood vessels and wet age-related macular degeneration (AMD) as well as other retinal disorders.
Development and Approval of EYLEA Drug Industry
Eylea was developed using Regeneron’s proprietary VelocImmune technology which enabled the company to rapidly isolate fully-human monoclonal antibodies. Preclinical studies in animals demonstrated the drug’s ability to reduce VEGF level and inhibit abnormal blood vessel growth. Initial clinical trials in wet AMD and diabetic macular edema (DME) patients yielded positive results, showing improvements in vision and retinal thickness.
Based on these results, EYLEA Drug received its first regulatory approval in 2011 from the FDA for the treatment of wet AMD. It was subsequently approved in Europe and other regions. Additional late-stage trials led to approvals for DME, retinal vein occlusion, and macular edema following retinal vein occlusion. Today, Eylea has regulatory approval in over 75 countries and is marketed by Bayer and Regeneron as a safe and effective treatment for several common retinal conditions caused by abnormal blood vessel growth and leakage.
Global Sales Success of Eylea
Eylea has grown to become one of the world’s top selling ophthalmic drugs with over $4 billion in annual sales. Much of this success can be attributed to its label expansions to additional indications which expanded the treatable patient population. In the United States alone, annual sales reached $1.8 billion in 2019, making it the leading drug for wet AMD. The global market for Eylea is expected to continue growing steadily driven by an aging population with higher risks of eye diseases.
While competition exists from other VEGF inhibitors like Lucentis, Eylea has demonstrated superior dosing flexibility with injections every 8-12 weeks versus monthly injections for Lucentis. This less frequent dosing translates to improved compliance and a better treatment experience for patients. Eylea’s strong clinical profile and greater practicality have allowed it earn up to a 50% market share in major markets like the US. These advantages will remain drivers of Eylea’s continued dominance for years to come.
Role of Eylea in Retinal Disease Treatment
Wet AMD is a leading cause of blindness among elderly populations in developed nations. It occurs when abnormal blood vessels grow under the retina, leading to leakage, scarring and loss of central vision over time. Prior to anti-VEGF therapies like Eylea and Lucentis, wet AMD severely impacted quality of life as patients lost independence and ability to perform daily tasks.
Eylea works by inhibiting VEGF and has demonstrated superior vision outcomes compared to older therapies. Clinical trials found a majority of wet AMD patients experienced vision improvement or stabilization after treatment with Eylea. By blocking abnormal new blood vessel growth, Eylea is able to stop further worsening of the disease and even partially reverse existing leakage and scarring in the retina. This allows wet AMD patients to retain vision critical for reading, driving and recognizing faces for longer.
Diabetic retinopathy, retinal vein occlusion and macular edema are other common retinal disorders also driven by elevated VEGF levels and growth of abnormal blood vessels. Eylea offers a valuable treatment option for these patient groups by blocking the underlying VEGF pathway promoting pathological angiogenesis. In clinical studies, Eylea achieved rapid and statistically significant improvements in visual acuity and retinal thickness for patients with DME, retinal vein occlusion, and macular edema.
Overall, While biosimilars to Eylea and Lucentis have begun entering markets, most analysts predict the branded anti-VEGF drugs will maintain market leadership given remaining patent protections and lack of demonstrated interchangeability of biosimilars in ophthalmology. Regeneron also continues investing in exploring additional indications and formulations to expand Eylea’s potential patient reach including for uncontrolled glaucoma, non-infectious uveitis, and wet age-related choroidal neovascularization.
In conclusion, Eylea has emerged as a breakthrough anti-VEGF therapy revolutionizing treatment of common retinal vessel disorders. Its global commercial success stems from demonstrated superior clinical efficacy improving vision for many blinding eye conditions. Eylea represents one of the great success stories in biopharmaceuticals, positively impacting over 1 million patients battling wet AMD, DME and other retinal diseases worldwide each year by preventing vision loss and restoring sight.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it