IZERVAY™ Generates Early Sales Momentum

Astellas Reports Preliminary U.S. Sales of IZERVAY™ Reach ¥15.9 Billion ($110 Million) in Q1 FY2025

Astellas Pharma , a leading global pharmaceutical company under the leadership of President and CEO Naoki Okamura, today announced preliminary sales figures for its recently acquired ophthalmology asset, IZERVAY™ (avacincaptad pegol intravitreal solution). The drug, indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), generated sales of approximately ¥15.9 billion (USD $110 million) in the United States during the first quarter of fiscal year 2025 (April 1, 2025 – June 30, 2025).

This early performance reflects robust commercial uptake of IZERVAY in a therapeutic area with substantial unmet need and underscores Astellas’ strategic commitment to expanding its presence in the ophthalmology space. The preliminary sales data were released today in conjunction with a scheduled investor meeting and ahead of the company’s Q1 FY2025 earnings announcement. Full financial results for the quarter, including detailed information on IZERVAY’s performance, will be presented and discussed during Astellas’ earnings call on July 30, 2025.

Strong Market Debut in a High-Need Therapeutic Area

IZERVAY™ represents a key innovation in the treatment of geographic atrophy, a progressive and irreversible form of AMD that leads to blindness in millions of patients globally. The disease affects the retinal pigment epithelium, photoreceptors, and choriocapillaris, and until recently, lacked any FDA-approved therapies capable of slowing its course.

IZERVAY, developed by Iveric Bio – which was acquired by Astellas in 2023 for $5.9 billion – was approved by the U.S. Food and Drug Administration in August 2023. The therapy is a complement C5 inhibitor that targets a critical component of the immune pathway implicated in retinal cell degeneration. Its monthly intravitreal administration has been shown in clinical trials to significantly reduce the rate of GA lesion growth, marking a major milestone in GA treatment.

Since its commercial launch, the drug has rapidly gained traction among retinal specialists and patients, reflecting both clinical demand and strong execution by Astellas’ commercial team in the United States.

Strategic Value of the Iveric Bio Acquisition

The preliminary sales figures also provide an early indicator of the success of Astellas’ acquisition strategy. The integration of Iveric Bio into Astellas’ broader portfolio was designed to strengthen the company’s position in the ophthalmology sector, complementing its existing focus areas in oncology, immunology, and neurology.

Naoki Okamura, President and CEO of Astellas, previously stated that the acquisition of Iveric Bio was “an essential step toward our goal of delivering value to patients through science.” The strong initial uptake of IZERVAY validates that strategic investment and affirms the potential for continued growth in the ophthalmic market segment.

In an environment where competition is intensifying and drug development timelines are increasingly compressed, Astellas’ ability to swiftly integrate and commercialize new assets stands out as a key differentiator.

A Rapidly Expanding Geographic Atrophy Market

The global burden of GA is expected to increase as populations age, particularly in developed nations. In the United States alone, more than 1 million people are estimated to suffer from geographic atrophy, and the prevalence is projected to double over the next two decades.

Despite the size and medical significance of the GA population, therapeutic options have historically been limited. The approval of IZERVAY, along with its competitor SYFOVRE™ (pegcetacoplan injection), marks a new era in GA management. However, IZERVAY’s differentiated mechanism and favorable injection profile have given it a competitive edge in real-world practice.

Retina specialists have also cited the drug’s safety profile and the potential for improved patient outcomes as factors contributing to its rapid adoption. Astellas has supported the launch with a comprehensive physician education campaign and patient access programs designed to reduce barriers to treatment.

Commercial Execution and Future Outlook

In addition to its scientific merits, the successful U.S. launch of IZERVAY highlights Astellas’ growing capabilities in commercial execution, particularly in the complex U.S. healthcare environment. The company has invested heavily in field force expansion, market access infrastructure, and digital engagement strategies to support the therapy’s rollout.

The $110 million in Q1 revenue is especially noteworthy given the relatively short time IZERVAY has been on the market. Analysts expect the drug to continue its upward trajectory in subsequent quarters, with some forecasting peak annual sales in excess of $1 billion globally.

Looking ahead, Astellas plans to expand IZERVAY’s reach by seeking regulatory approvals in additional markets, including Europe and Asia. The company is also exploring potential label expansions based on ongoing clinical trials that may support broader indications or improved dosing regimens.

Furthermore, Astellas has emphasized its commitment to ophthalmology through continued R&D investment. The company’s pipeline includes next-generation complement inhibitors, gene therapies, and combination approaches aimed at addressing not only GA but also other forms of retinal degeneration and vision-threatening diseases.

Earnings Call and Investor Communication

While today’s disclosure focuses on preliminary sales data for IZERVAY, Astellas has indicated that a more comprehensive update on the company’s overall financial performance for Q1 FY2025 will be shared during its quarterly earnings call scheduled for July 30, 2025. Investors and analysts are expected to receive additional insights into revenue drivers, operating margin trends, and updates on other key pipeline assets.

The earnings call will also provide management with an opportunity to articulate its vision for continued value creation, particularly in light of recent macroeconomic challenges and evolving regulatory landscapes.

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