EYLEA: A Blockbuster Drug for Wet Age-related Macular Degeneration

Wet Age-related Macular Degeneration (AMD) is a leading cause of blindness among elderly people worldwide. EYLEA, developed by Regeneron Pharmaceuticals Inc., is a potent anti-VEGF drug approved for the treatment of Wet AMD. Since its approval in 2011, EYLEA has revolutionized the treatment of this devastating eye disease. Let’s take a deeper look into this blockbuster drug.

What is Wet AMD?

Age-related Macular Degeneration (AMD) is a medical condition that damages the macula, the central part of the retina. The macula is responsible for central vision which is needed for reading, driving and other daily tasks. There are two main types of AMD – wet and dry.

Wet AMD, also known as neovascular or exudative AMD, is an advanced form of the disease where new, abnormal blood vessels start growing under the macula. These fragile vessels tend to leak fluid and blood, causing rapid damage to the macula. Wet AMD accounts for around 10-15% of all AMD cases but is responsible for 90% of severe vision loss associated with AMD. Left untreated, Wet AMD can lead to permanent central blindness within a few months.

Mechanism of Action of EYLEA

EYLEA (aflibercept) is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2. It works by inhibiting Vascular Endothelial Growth Factor (VEGF) – a protein that promotes formation of new blood vessels.

Uncontrolled growth of abnormal blood vessels is a hallmark of Wet AMD which occurs due to overproduction of VEGF in the eye. EYLEA is able to bind VEGF molecules more tightly than their natural receptors. This prevents VEGF from binding and activating its receptors on endothelial cells. As a result, EYLEA is highly effective at blocking the VEGF pathway which is responsible for neo-vascularization in Wet AMD.

Key Clinical Trial Results

According to clinical trials, EYLEA has demonstrated superior vision gains and longer lasting effects compared to other anti-VEGF agents in multiple ocular conditions. CoherentMI discusses the key clinical trial results in Global EYLEA Drug Market as:

VIEW 1 and VIEW 2 Trials in Wet AMD

The VIEW 1 and VIEW 2 pivotal phase 3 studies evaluated the efficacy and safety of EYLEA injections versus ranibizumab injections for wet AMD. In both studies, EYLEA dosed every 8 weeks after 3 initial monthly injections demonstrated non-inferior vision gains compared with monthly ranibizumab over 2 years.


The VIBRANT and MONET phase 3 studies evaluated the efficacy and safety of EYLEA vs laser photocoagulation in DME patients. At 2 years, EYLEA-treated patients gained approximately 15 letters on average compared with 8 letters in laser-treated patients. Nearly 60% of EYLEA patients achieved >15 letter gains.

Phase 3 Studies in RVO

In two phase 3 studies (COPERNICUS and GALILEO) in RVO, EYLEA demonstrated rapid and superior vision gains versus laser at 6 months. At 2 years, EYLEA patients maintained average gains of 17–19 letters.

Phase 3 Study in Proliferative DR

The PANORAMA study found that significantly more EYLEA-treated patients achieved the primary endpoint of ‘No DR worsening’ at Week 100 versus sham injection. Taken together, these robust results across multiple indications have positioned EYLEA as the market leader.

Safety Profile

Overall, EYLEA has consistently demonstrated a favorable safety profile comparable to other anti-VEGF therapies. The most common adverse events observed in clinical trials were conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. No new or unexpected safety issues emerged with longer term use up to 5 years. This favorable benefit-risk assessment has supported EYLEA’s expanding role as a mainstay therapy.

Performance and Adoption

Coming in the already established anti-VEGF market dominated by Lucentis and Avastin, EYLEA managed to quickly capture a significant market share due to its differentiated profile. For more detail on its market performance and factors responsible for it, refer to the in-depth market analysis published on CoherentMI.

Since launch, EYLEA has consistently grown to become the largest selling ophthalmic drug in the world with annual sales surpassing $10 billion. Today, it holds a lion’s share of over 60% of the global Wet AMD market. EYLEA is regarded as the gold standard of care for Wet AMD due to its proven safety, efficacy and convenient dosing regime.

Other Approved Indications

Given success in Wet AMD, EYLEA has also been approved and adopted for treatment of other retinal vascular disorders driven by abnormal VEGF signaling. This includes Macular Edema following Retinal Vein Occlusion, Diabetic Macular Edema and Diabetic Retinopathy.

Clinical trials demonstrated significant gains in vision and anatomical outcomes with EYLEA in these additional indications. Its expanding label further enhances the drug’s commercial potential while providing benefit to more patients worldwide. Ongoing research is also evaluating EYLEA for several other ophthalmic conditions.

Market Outlook

The global market for EYLEA remains very promising. While the U.S. and European regions currently dominate sales, emerging markets in Asia Pacific and Latin America show high growth potential. Greater awareness, screening programs, and access to novel anti-VEGF therapies will drive the adoption of EYLEA in these regions. Moreover, approval for additional retinal conditions expands the treatable patient pool augmenting future revenues. Barring any biosimilar competition, EYLEA is positioned for continued market leadership over the next decade.

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