EYLEA HD Drug Profile

Summary for Tradename: EYLEA HD

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for EYLEA HD

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for EYLEA HD Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for EYLEA HD Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Regeneron Pharmaceuticals, Inc.	EYLEA HD	aflibercept	Injection	761355	10,130,681	2037-03-28	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA HD	aflibercept	Injection	761355	10,828,345	2038-10-12	Company disclosures
Regeneron Pharmaceuticals, Inc.	EYLEA HD	aflibercept	Injection	761355	11,066,458	2039-09-25	Company disclosures

3) Low Certainty: US Patents for EYLEA HD Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Regeneron Pharmaceuticals, Inc.	EYLEA HD	aflibercept	Injection	761355	10,004,788	2032-05-15	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA HD	aflibercept	Injection	761355	10,047,096	2034-11-25	Patent claims search
Regeneron Pharmaceuticals, Inc.	EYLEA HD	aflibercept	Injection	761355	10,077,280	2036-04-22	Patent claims search

EYLEA HD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EYLEA HD

Introduction to EYLEA HD

EYLEA HD, developed by Regeneron Pharmaceuticals, is a high-dose version of the anti-vascular endothelial growth factor A (VEGF-A) inhibitor aflibercept, approved by the FDA in August 2023. This drug is designed to treat various retinal diseases, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO)[4].

Market Competition

The ophthalmology market, particularly for anti-VEGF treatments, is highly competitive, with Roche's Vabysmo being a significant competitor. Vabysmo, a bispecific antibody that blocks Ang-2 and VEGF, was approved by the FDA in 2022 and has been gaining market share. However, the launch of EYLEA HD has helped Regeneron maintain its market position, with analysts predicting that EYLEA HD and Vabysmo will dominate the market by 2030, capturing over 60% of the sector[1].

Sales Performance

EYLEA HD has shown impressive sales figures since its approval. In the first half of 2024, it generated $504 million in sales, helping Regeneron maintain revenues from the overall EYLEA franchise at a similar level to the first half of 2023. The drug's sales have grown 67% quarter-over-quarter, with utilization among treatment-naive patients doubling quarter-over-quarter[1][3].

Financial Impact

Regeneron's overall revenue has surged due to the significant growth in EYLEA HD sales. In the second quarter of 2024, the company's revenue increased by 12% year-over-year to $3.55 billion, driven by the strong performance of EYLEA HD, along with other key products like Dupixent and Libtayo[2].

Forecast and Projections

Analysts forecast that EYLEA HD sales will reach $1.4 billion in 2024 and continue to climb to $5.5 billion by 2030. This growth is expected to be driven by the transition of patients from other anti-VEGF products, including the original EYLEA, as well as the addition of new patients naïve to anti-VEGF therapy[1].

Patient Transition and Market Share

Patients are increasingly switching to EYLEA HD from both the original EYLEA and Vabysmo. This transition, combined with the drug's strong efficacy and safety profile, has helped EYLEA HD maintain a significant market share. As of the third quarter of 2024, the combined EYLEA products held 45% of the market[1][3].

Clinical Efficacy and Long-Term Data

The three-year results for EYLEA HD have been promising, with 88% of patients maintaining 12-week dosing intervals and 48% achieving 20-week intervals for diabetic macular edema. This extended dosing interval could drive preference for EYLEA HD over competitors, potentially increasing Regeneron's market share in DME treatment[5].

Cost Efficiency and Payer Attractiveness

The reduced treatment frequency of EYLEA HD may lower healthcare system costs, making it more attractive to payers and potentially expanding access to the drug. This cost efficiency, coupled with improved efficacy and patient preference, could lead to broader adoption and offset any revenue reduction due to fewer injections per patient[5].

Global Market Reach

Regeneron's partnership with Bayer for ex-U.S. markets ensures a global reach for EYLEA HD, which is expected to drive significant revenue growth. The global EYLEA drug market is projected to reach $14.30 billion by 2030, with North America leading the market and the Asia Pacific region being the fastest-growing[4].

Challenges and Restraints

Despite the strong market dynamics, the EYLEA HD market faces challenges such as side effects, which are a key factor hampering growth. Reducing these side effects during the manufacturing process is crucial for broader acceptance and market growth[4].

R&D and Pipeline

Regeneron continues to invest heavily in its clinical pipeline, with approximately 40 product candidates in clinical development. The success of EYLEA HD validates Regeneron's R&D investments in ophthalmology, supporting investor confidence in the company's pipeline[3].

Future Launches and Innovations

Regeneron is planning to launch a prefilled syringe version of EYLEA HD in early 2025, which is expected to enhance patient convenience and further solidify the drug's market position. CEO Leonard Schleifer remains confident that the attributes of EYLEA HD, including its durability and safety profile, will continue to drive its success despite any potential competition[1].

Key Takeaways

• Strong Sales Performance: EYLEA HD has generated significant revenue since its approval, with a 67% quarter-over-quarter growth.
• Market Dominance: EYLEA HD and Vabysmo are expected to dominate the anti-VEGF market by 2030.
• Clinical Efficacy: Three-year data shows promising results for EYLEA HD, with extended dosing intervals.
• Global Reach: Partnership with Bayer ensures global distribution, driving revenue growth.
• Challenges: Side effects remain a key factor to address for broader market acceptance.

FAQs

What is EYLEA HD and how does it work?

EYLEA HD is a high-dose version of the anti-VEGF-A inhibitor aflibercept, used to treat retinal diseases by inhibiting the abnormal growth of blood vessels in the eye.

How has EYLEA HD performed in terms of sales since its approval?

EYLEA HD generated $504 million in sales in the first half of 2024 and has shown a 67% quarter-over-quarter growth, making it one of the fastest-growing products in the category.

What are the key factors driving the growth of the EYLEA HD market?

The growth is driven by the increasing prevalence of eye diseases, a growing geriatric population, and the transition of patients from other anti-VEGF products to EYLEA HD.

Which regions are expected to lead the EYLEA HD market?

North America is expected to be the largest market, while the Asia Pacific region is forecasted to be the fastest-growing.

What are the potential challenges for EYLEA HD in the market?

Side effects are a key factor hampering the growth of the EYLEA HD market, and reducing these side effects is crucial for broader acceptance.

Cited Sources

1. Biospace: Roche and Regeneron Square Off in Lucrative Eye Disease Market
2. Synapse: Regeneron Announces Q2 2024 Financial and Operating Results
3. Biospace: Regeneron Reports Third Quarter 2024 Financial and Operating Results
4. Coherent Market Insights: Global EYLEA Drug Market Size & Share Analysis - Growth Trends
5. Stock Titan: Three-year Results for EYLEA HD® (aflibercept) Injection 8 mg