Bausch & Lomb's Miebo Costs 40 Times More Than European Equivalent, Highlighting Regulatory Pricing Loopholes
核心洞察
Bausch & Lomb's prescription dry eye drug Miebo costs over $800 monthly in the U.S., while the identical drug EvoTears (搜索) sells over-the-counter in Europe for approximately $20.
The company achieved $172 million in 2024 sales by securing FDA approval as a prescription medication rather than pursuing over-the-counter status like in Europe.
This pricing strategy exemplifies how pharmaceutical companies exploit regulatory loopholes, with U.S. drug prices averaging 2.5 times higher than other developed nations.
A month's supply of Miebo, Bausch & Lomb's prescription dry eye drug, costs $800 or more in the U.S. before insurance, while the identical drug—sold as EvoTears (搜索)—has been available over-the-counter in Europe since 2015 for about $20. This stark price differential exemplifies how pharmaceutical companies exploit regulatory loopholes to maximize profits at patients' expense.
Strategic Prescription Pathway Drives Revenue
In December 2019, Bausch & Lomb acquired the exclusive license for NOV03 (now Miebo) in the United States and Canada. Rather than pursuing over-the-counter approval like in Europe, the company secured FDA approval as a prescription medication. According to GoodRx (搜索), a monthly supply currently costs $830.27 at Walgreens and $818.38 on Amazon Pharmacy.
The strategy has proven financially successful. Miebo's 2024 sales—its first full year—reached $172 million, surpassing the company's initial projections of $95 million. Bausch & Lomb now forecasts annual sales exceeding $500 million. At European pricing levels, those same sales would generate less than $20 million. The company raised Miebo's price an additional 4% in 2025, according to drug price tracking firm 46brooklyn (搜索).
Regulatory Justification Questioned
When questioned about Miebo's prescription status and pricing, Bausch & Lomb stated: "The FDA determined that MIEBO acts at the cellular and molecular level of the eye, which meant it had to go through the same rigorous process as any new pharmaceutical—a full New Drug Application. Unlike in Europe, where all medical device eye drops are prescription-free and cleared through a highly predictable and fast pathway, we were required to design, enroll and complete extensive clinical trials involving thousands of patients."
However, this explanation sidesteps the core issue. The FDA's test for over-the-counter status centers on whether patients can use a drug safely without physician supervision, not its mechanism of action. EvoTears (搜索)' nearly decade-long track record as an over-the-counter product in Europe demonstrates it meets safety standards for unsupervised use.
Pattern of Pricing Practices
Bausch & Lomb, formerly part of Valeant (搜索), has a documented history of aggressive pricing strategies. In 2015, the company raised prices for Nitropress and Isuprel by over 200% and 500%, respectively, triggering a 2016 congressional hearing. Current CEO Brent Saunders previously attempted to extend patent protection for Allergan's dry eye drug Restasis through a controversial deal with the Mohawk Indian tribe, which courts later rejected.
Broader Market Context
A 2021 RAND study found U.S. prescription drug prices are, on average, more than 2.5 times higher than in 32 other developed nations. Miebo represents one example of how companies exploit regulatory differences between countries to maintain pricing advantages. Even insured patients face consequences, as insurers pay hundreds per prescription, driving up premiums and overall healthcare costs.
Proposed Regulatory Solutions
The FDA could address this loophole by requiring drugs approved as over-the-counter internationally to be evaluated for U.S. OTC status before receiving prescription approval. This would involve adjusting the FDA's OTC monograph process to incorporate mechanisms ensuring overseas OTC status triggers review of U.S. prescription drugs with identical active ingredients.
Such reforms would need to establish criteria for assessing safety and efficacy equivalency between U.S. and international OTC standards, plus create retroactive review pathways for existing prescription drugs already marketed over-the-counter internationally. This approach could deter companies from repackaging OTC drugs as high-cost prescriptions while fostering competition and reducing prices.
Healthcare Access Implications
The pricing disparity affects patient access to treatment. Some patients skip doses to afford other necessities, while the administrative burden of prescription requirements increases healthcare system costs through additional doctor visits and pharmacy processing. Global reference pricing aligned with European levels could significantly reduce these barriers while maintaining treatment efficacy.
The case highlights how unexplained price differences between the U.S. and other wealthy countries erode public trust in healthcare systems, with companies exploiting regulatory gaps while patients and payers bear the financial burden.