PURPOSE: Lifitegrast ophthalmic solution 5.0% (Xiidra®) is approved for the treatment of signs and symptoms of dry eye disease (DED). This study reports the real-world safety and tolerability experience of lifitegrast in patients with DED.

METHODS: This was a multicenter, retrospective chart review and provider survey conducted across U.S. eye care practices. Eligible patients were adults (≥18 years) with a clinical diagnosis of DED who had initiated treatment with lifitegrast for ≥30 days. Providers documented patient demographics, baseline DED severity, prior therapies, and treatment-emergent adverse events (TEAEs). Safety outcomes included incidence of ocular and systemic TEAEs, severity, time to onset, and treatment discontinuation due to AEs.

RESULTS: Data were collected from a total of providers and patients across U.S. sites. The majority of patients were female with a mean age in the 50s-60s. Most commonly reported TEAEs were ocular and mild-to-moderate in severity, including instillation-site reactions (burning, irritation), dysgeusia (altered taste), and transient blurred vision. The majority of TEAEs occurred within the first 2 weeks of treatment and resolved without intervention. The discontinuation rate due to AEs was low. No serious treatment-related adverse events were reported. The overall safety profile in this real-world setting was consistent with that observed in pivotal clinical trials.

CONCLUSIONS: This real-world analysis confirms the favorable safety and tolerability profile of lifitegrast ophthalmic solution 5.0% in patients with DED. The most common adverse events were mild and transient, supporting the use of lifitegrast as a well-tolerated long-term treatment option for inflammatory DED in routine clinical practice.