Introduction to EYSUVIS
EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is a groundbreaking medication approved by the FDA for the short-term treatment (up to two weeks) of the signs and symptoms of dry eye disease. Developed by Kala Pharmaceuticals, EYSUVIS utilizes the innovative AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to enhance the delivery of loteprednol etabonate into the target tissues of the ocular surface[1].
Market Demand and Growth
The dry eye disease market is expected to grow significantly, driven by the increasing prevalence of the condition, particularly among the elderly population. The market is projected to reach USD 6.11 billion by 2024 and grow at a CAGR of 4.09% to reach USD 7.46 billion by 2029. The corticosteroid segment, which includes EYSUVIS, is anticipated to hold a major market share due to its efficacy and rising product approvals[3].
Prescription Growth and Adoption
Since its launch in January 2021, EYSUVIS has shown promising prescription growth. In the first quarter of 2022, 26,518 EYSUVIS prescriptions were filled, representing an 18% quarter-over-quarter growth. As of March 18, 2022, over 86,969 prescriptions, including refill prescriptions, were filled by more than 7,400 unique prescribers. This growth is attributed to expanded commercial and Medicare coverage, now covering over 125 million total lives[1][4].
Coverage and Access
Kala Pharmaceuticals has made significant strides in expanding market access for EYSUVIS. As of the first quarter of 2022, EYSUVIS coverage had expanded to 92% of total commercial lives and 30% of all Medicare lives. This expanded coverage is expected to reduce the impact of patient assistance programs on the average selling price and net revenue[1].
Pricing and Cost
The Wholesale Acquisition Cost (WAC) for a 10 mL bottle of EYSUVIS is set at $465. However, the cash price for an 8.3 mL supply can range around $544, depending on the pharmacy. Patients can use discount cards and copay cards to reduce the cost, with some programs offering savings of up to 80%[2][5].
Financial Performance
In the first quarter of 2022, Kala reported net product revenues of $1.4 million from EYSUVIS sales, which, although lower than the previous year, reflects the impact of patient assistance programs. The company anticipates that its current cash resources, along with anticipated revenue from EYSUVIS and INVELTYS, will fund operations into the second quarter of 2023[1].
Competitive Landscape
The dry eye disease treatment market is competitive, with various treatments available, including other corticosteroids and non-corticosteroid options. However, EYSUVIS's unique delivery technology and FDA approval for short-term treatment of dry eye disease position it as a preferred option for mild or moderate cases. The recent approval of other loteprednol etabonate formulations, such as the ophthalmic gel, also indicates a growing market for corticosteroid treatments[3].
Future Outlook and Projections
Given the growing demand for dry eye disease treatments and the specific advantages of EYSUVIS, the product is expected to continue its upward trajectory. Here are some key projections:
- Increased Prescription Volume: With expanded coverage and ongoing marketing efforts, EYSUVIS prescription growth is likely to continue, contributing to higher revenues.
- Market Share: The corticosteroid segment, led by EYSUVIS, is expected to maintain a significant market share due to its efficacy and the rising prevalence of dry eye disease.
- Revenue Growth: As patient assistance programs have less impact on the average selling price, net revenues from EYSUVIS sales are anticipated to increase.
- Clinical Trials and Expansion: Kala's ongoing development of KPI-012 for persistent corneal epithelial defect (PCED) and other ocular diseases could further enhance the company's market position and revenue streams[1][3].
Challenges and Opportunities
While EYSUVIS faces competition from other treatments, its unique delivery technology and FDA approval present significant opportunities. Challenges include managing the impact of patient assistance programs on revenue and navigating the competitive landscape. However, the growing elderly population and increasing prevalence of dry eye disease provide a robust market for EYSUVIS to expand within.
Key Takeaways
- Market Growth: The dry eye disease market is expected to grow significantly, driven by the elderly population and rising product approvals.
- Prescription Growth: EYSUVIS has shown strong prescription growth since its launch, with expanded coverage contributing to this trend.
- Pricing and Cost: The drug is priced competitively, with discount programs available to reduce costs for patients.
- Financial Performance: Despite current revenue challenges, EYSUVIS is expected to contribute significantly to Kala's revenues in the future.
- Future Outlook: EYSUVIS is poised for continued growth, driven by its unique technology and expanding market access.
Frequently Asked Questions (FAQs)
Q: What is EYSUVIS used for?
A: EYSUVIS is used for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
Q: How does EYSUVIS work?
A: EYSUVIS uses the AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to enhance the delivery of loteprednol etabonate into the target tissues of the ocular surface.
Q: What is the current market coverage for EYSUVIS?
A: As of the first quarter of 2022, EYSUVIS coverage had expanded to 92% of total commercial lives and 30% of all Medicare lives.
Q: How much does EYSUVIS cost?
A: The cash price for an 8.3 mL supply of EYSUVIS can range around $544, but discount programs can reduce this cost.
Q: What are the future prospects for EYSUVIS?
A: EYSUVIS is expected to continue growing in prescription volume and revenue, driven by its unique technology and expanding market access.
Cited Sources:
- Kala Reports First Quarter 2022 Financial Results and Provides Corporate Update - Kala Pharmaceuticals.
- Eysuvis Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com.
- Dry Eye Disease Market Report | Industry Analysis, Size & Forecast - Mordor Intelligence.
- Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2021 - Kala Pharmaceuticals.
- Kala Pharmaceuticals Provides Update on Launch Plans for EYSUVIS - Kala Pharmaceuticals.
