Ownership Changes and the Rumor Mill
Understanding the ownership history of Xiidra (lifitegrast) is key to dispelling the rumors. The drug was initially developed and brought to market by Shire plc, receiving FDA approval in 2016 for the treatment of signs and symptoms of dry eye disease. In 2019, following a major acquisition, Shire's assets, including Xiidra, were absorbed by Takeda. Takeda, in turn, quickly sold Xiidra to Novartis for an upfront payment of $3.4 billion. This rapid succession of high-profile corporate dealings began to fuel speculation about the drug's long-term future. However, the most significant shift occurred in September 2023 when Bausch + Lomb completed its acquisition of Xiidra from Novartis.
Novartis's decision to divest the 'front of eye' assets, including Xiidra, was part of a broader corporate strategy to focus on its core therapeutic areas. This move, combined with the earlier withdrawal of Xiidra's marketing application in Europe by Novartis in 2020 due to regulatory objections, further amplified unfounded rumors that the drug was being discontinued entirely. For consumers in the United States, however, the series of sales and divestitures simply meant a change in the product's manufacturer, not its availability.
Dispelling the Myth: Xiidra's Current Market Status
Contrary to the persistent rumors, Xiidra has not been taken off the market and is still available as a prescription medication in the United States. Its current manufacturer is Bausch + Lomb, which has been actively promoting the medication and its associated patient savings programs. The FDA approval for Xiidra remains fully intact, and it continues to be prescribed for the treatment of dry eye disease. Any confusion surrounding a potential recall is likely related to separate, unrelated recalls of different eye drop products in the market, not Xiidra itself.
For patients concerned about their medication, the primary change is the company responsible for its manufacturing and marketing. The formulation of the lifitegrast ophthalmic solution remains the same as when it was first approved by the FDA in 2016. Patients should continue to follow their prescribing physician's instructions regarding its use.
Understanding Dry Eye and Xiidra's Role
Dry eye disease is a chronic condition characterized by insufficient tear production or poor tear quality. This can lead to discomforting symptoms such as eye irritation, a gritty sensation, and blurred vision. Xiidra is a specialized medication known as a lymphocyte function-associated antigen-1 (LFA-1) antagonist. It works by inhibiting inflammation in the ocular surface, which is often a root cause of dry eye symptoms. By blocking the interaction of specific proteins with white blood cells, it helps to reduce the inflammatory response that contributes to dry eye disease. This mechanism of action differentiates it from other treatments that primarily focus on tear lubrication or production.
Comparison Table: Xiidra vs. Other Dry Eye Treatments
| Feature | Xiidra (Lifitegrast) | Restasis (Cyclosporine) | Miebo (Perfluorohexyloctane) |
|---|---|---|---|
| Manufacturer | Bausch + Lomb | Allergan (AbbVie) | Bausch + Lomb |
| Mechanism of Action | LFA-1 antagonist; treats inflammation | Calcineurin inhibitor; increases tear production | Blocks tear evaporation |
| Initial FDA Approval | 2016 | 2003 | 2023 |
| Key Focus | Targeting inflammation to reduce signs and symptoms | Boosting natural tear production over time | Addressing tear evaporation caused by meibomian gland dysfunction |
| Current Availability | Fully available on US market | Fully available on US market | Fully available on US market |
Addressing European Market Differences
Another factor contributing to the rumors was the different regulatory path taken in Europe. In 2020, Novartis withdrew its marketing authorization application (MAA) for Xiidra in the European Union. This was due to significant objections raised by the European Medicines Agency (EMA), which questioned the clinical significance of the drug's benefits, particularly regarding symptom reduction. The withdrawal was a strategic decision by Novartis at the time, but it did not impact the drug's approval or availability in the United States, which is regulated by the FDA. This distinction between the US and European markets is a crucial point that was often lost in the public discussion surrounding the drug's status.
Recent Recalls vs. Xiidra
In early 2025, there were several high-profile recalls of over-the-counter and some prescription eye drop products due to sterility concerns. These recalls received significant media attention and led many consumers to mistakenly believe that Xiidra was also affected. It is important to note that these recalls involved different manufacturers and products and were completely unrelated to Xiidra. Bausch + Lomb has continued to produce and distribute Xiidra without any recall notices. For accurate recall information, it is always best to consult the official website of the Food and Drug Administration (FDA) and the current manufacturer, Bausch + Lomb.
Conclusion
In conclusion, any claims that Is Xiidra being taken off the market? are false. The medication is still available by prescription for the treatment of dry eye disease in adults in the United States. While the drug has been part of a series of corporate acquisitions, most recently by Bausch + Lomb in 2023, these changes have not resulted in its discontinuation. Rumors likely stem from the shift in ownership and the separate withdrawal of a marketing application in Europe. Patients can confidently continue to obtain their Xiidra prescription from their healthcare providers.
