Introduction to EYSUVIS
EYSUVIS, developed by Kala Pharmaceuticals, is a significant advancement in the treatment of dry eye disease. It is the first and only FDA-approved medicine specifically indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
Clinical Trials and FDA Approval
The FDA approval of EYSUVIS was based on the results of four clinical trials, including three Phase 3 trials and one Phase 2 trial. These trials demonstrated significant improvements in both the signs and symptoms of dry eye disease.
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STRIDE 3 Trial: This was a multicenter, randomized, double-masked, placebo-controlled trial involving approximately 900 patients. The trial compared EYSUVIS to a vehicle (placebo), each dosed four times a day for two weeks. The results showed statistical significance in the sign endpoint of conjunctival hyperemia in all three Phase 3 trials and in the symptom endpoints of ocular discomfort severity in two of the three Phase 3 trials[1][4].
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Key Outcomes: The trials indicated that EYSUVIS was well-tolerated, with adverse events and intraocular pressure increases comparable to those observed with the vehicle. This robust clinical data supported the FDA's decision to approve EYSUVIS on October 26, 2020[1].
Market Analysis
Current Market Size and Growth
The dry eye disease market, in which EYSUVIS operates, is projected to grow substantially over the next few years.
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Market Size: The dry eye disease market is expected to reach USD 6.36 billion in 2025 and grow at a CAGR of 4.09% to reach USD 7.77 billion by 2030[2].
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Regional Dominance: North America is expected to hold the largest market share due to the high prevalence of dry eye disease and the easy availability of therapeutic solutions in the region. The Asia-Pacific region is anticipated to be the fastest-growing market over the forecast period[2].
Key Factors Driving Growth
Several factors are driving the growth of the dry eye disease market, including:
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High Prevalence: The prevalence of dry eye disease is significant, especially in regions like North America. For instance, the prevalence of dry eye disease in Canada is estimated at 21%, with certain demographics like women using eye cosmetics being at higher risk[2].
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Technological Advancements: The launch of novel products like EYSUVIS and Cequa (cyclosporine ophthalmic solution) has contributed to market growth. These products offer more effective and targeted treatments for dry eye disease[2].
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Market Access and Coverage: EYSUVIS has gained significant coverage through major healthcare providers. For example, UnitedHealthcare has added EYSUVIS to its commercial formularies, covering approximately 70% of all commercial lives. Additionally, Cigna Medicare has included EYSUVIS as a preferred brand, further expanding its market reach[5].
Market Projections for EYSUVIS
Prescription Growth and Market Penetration
Since its commercial launch in January 2021, EYSUVIS has shown promising growth in prescription numbers.
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Prescription Data: As of May 6, 2022, over 103,514 prescriptions of EYSUVIS had been filled, including more than 17,955 refill prescriptions, written by over 8,200 unique prescribers. This represents an 18% quarter-over-quarter growth in the first quarter of 2022[3].
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Patient Assistance Programs: Kala Pharmaceuticals has utilized patient assistance programs to ensure prescriptions are filled, which has contributed to increased usage but also impacted net revenues. However, with expanded payor coverage, the impact on net revenue is expected to diminish[3].
Technological Advantage
EYSUVIS utilizes Kala's AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology, which enhances the penetration of loteprednol etabonate into the target tissue of the ocular surface. This technology has been shown to increase the delivery of the active ingredient more than three-fold compared to an active comparator in preclinical studies[3].
Competitive Landscape
The dry eye disease market is competitive, with several major players operating in the space.
- Key Players: Companies like Santen Pharmaceutical Co. Ltd, OASIS Medical, Alcon Inc., Bausch Health Companies Inc., and AbbVie Inc. (Allergan PLC) are significant competitors in the market[2].
Future Outlook
Expansion and Development
Kala Pharmaceuticals continues to expand its portfolio and develop new treatments. For instance, the company is progressing with the development of KPI-012, which has broad potential to change the standard of care in persistent corneal epithelial defect (PCED) and other rare and severe ocular diseases. A Phase 2/3 clinical trial for KPI-012 is planned, subject to regulatory clearance[3].
Key Takeaways
- FDA Approval: EYSUVIS was approved by the FDA in October 2020 based on robust clinical trial data.
- Market Growth: The dry eye disease market is projected to grow to USD 7.77 billion by 2030, with North America holding the largest share.
- Prescription Growth: EYSUVIS has shown significant prescription growth since its launch, with over 103,514 prescriptions filled as of May 2022.
- Technological Advantage: EYSUVIS uses AMPPLIFY® MPP Drug Delivery Technology, enhancing the delivery of the active ingredient.
- Competitive Landscape: The market is competitive, but EYSUVIS has gained substantial coverage through major healthcare providers.
FAQs
What is EYSUVIS approved for?
EYSUVIS is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease[1].
How was EYSUVIS tested in clinical trials?
EYSUVIS was tested in four clinical trials, including three Phase 3 trials and one Phase 2 trial, which demonstrated significant improvements in both the signs and symptoms of dry eye disease[1].
What is the current market size of the dry eye disease market?
The dry eye disease market is expected to reach USD 6.36 billion in 2025[2].
Which region is expected to grow the fastest in the dry eye disease market?
The Asia-Pacific region is estimated to grow at the highest CAGR over the forecast period (2025-2030)[2].
How many prescriptions of EYSUVIS have been filled since its launch?
As of May 6, 2022, over 103,514 prescriptions of EYSUVIS had been filled since its launch in January 2021[3].
Sources
- Kala Pharmaceuticals Announces FDA Approval of EYSUVIS™ for Short-Term Treatment of Dry Eye Disease. Kala Pharmaceuticals.
- Dry Eye Disease Market Report | Industry Analysis, Size & Forecast. Mordor Intelligence.
- Kala Reports First Quarter 2022 Financial Results and Provides Business Update. Kala Pharmaceuticals.
- Kala Pharmaceuticals Announces Completion of Enrollment of STRIDE 3 Trial for EYSUVIS™ (KPI-121 0.25%) for Dry Eye Disease. Kala Pharmaceuticals.
- Kala Pharmaceuticals: EYSUVIS now covered on UnitedHealthcare commercial, Cigna Medicare. Optometry Times.
