Bausch & Lomb's lifitegrast ophthalmic solution 5% (Xiidra) has demonstrated a favorable long-term safety profile and sustained efficacy for patients with dry eye disease (DED), according to new data presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
A comprehensive postmarketing analysis spanning seven years revealed no new safety signals among an estimated 789,901 patient treatment years, reinforcing the medication's established safety profile since its FDA approval in July 2016.
"Long-term experience with lifitegrast was not associated with identification of new or changing safety signals during routine safety monitoring," reported the investigative team led by Clara C. Chan, MD, associate professor of ophthalmology at the University of Toronto and medical director of the Eye Bank of Canada. "These findings support the favorable safety and tolerability profile of lifitegrast in the treatment of patients with DED."
Extensive Safety Analysis Confirms Favorable Profile
The postmarketing safety evaluation examined data from FDA approval through July 2023 using the company's safety database, which includes reports from both patients and healthcare providers. Researchers calculated exposure to lifitegrast based on the total amount distributed worldwide, assuming two single-use containers (0.4 mL) per patient daily.
Common adverse events identified in clinical trials remained consistent with previous findings, including eye irritation (0.19 cases per 100 treatment-years), instillation site reaction (0.13 per 100 treatment-years), eye pain (0.07 per 100 treatment-years), blurred vision (0.23 per 100 treatment-years), and dysgeusia (0.08 per 100 treatment-years). Notably, hypersensitivity reporting rates were low at 0.19 cases per hundred patient treatment years.
The analysis found no significant safety differences between elderly and younger adult patients, with no evidence suggesting the need for dosage adjustments in older populations.
Real-World Efficacy Demonstrates Rapid and Sustained Response
A separate real-world assessment presented at the same meeting evaluated lifitegrast's effectiveness through both quantitative surveys and qualitative case studies. The analysis, led by Francis S. Mah, MD, director of cornea and external disease at Scripps Clinic Medical Group, included data from 12 eyecare providers who collectively treat approximately 1,288 DED patients annually.
Results showed that nearly two-thirds (67%) of providers reported patients achieving near or complete symptom resolution after just 1-3 months of lifitegrast treatment. The medication demonstrated sustained improvement during treatment periods extending up to 12 months, with case data supporting continued efficacy for an average of 15 months.
"Quantitative survey and qualitative case data highlight the rapid and durable response associated with lifitegrast for the treatment of patients with DED," Mah and colleagues reported. "Lifitegrast is used frequently in the management of DED in contact lens wearers and in patients undergoing various ocular surgeries."
Versatile Applications in Specialized Patient Populations
The real-world assessment revealed lifitegrast's versatility across various clinical scenarios. Nearly all surveyed providers (92%) reported using lifitegrast to treat contact lens-induced DED, while 83% utilized it before or after refractive or cataract surgery.
Provider satisfaction ratings for onset of action and overall effectiveness averaged 6.8 and 6.6 out of 10, respectively. Case report data from 36 patients (average age 51 years) showed sustained improvement over an average treatment duration of 29 months with approximately 5 follow-up visits per patient.
Safety findings from the real-world assessment aligned with the postmarketing analysis, with 58% of providers reporting at least one patient experiencing an adverse event during treatment. These events, including blurred vision, burning/stinging, and dysgeusia, were consistently rated as mild to moderate in severity.
Clinical Context and Significance
Dry eye disease represents a significant clinical challenge affecting millions worldwide, with symptoms ranging from irritation and discomfort to visual disturbances that can significantly impact quality of life. The condition is particularly prevalent among contact lens wearers and patients undergoing ocular surgeries.
Lifitegrast, which received FDA approval in 2016 based on five randomized, placebo-controlled trials (including the Phase 3 OPUS-1, OPUS-2, OPUS-3, and SONATA trials), works by inhibiting T-cell-mediated inflammation associated with dry eye disease.
These new findings provide reassurance to clinicians regarding lifitegrast's long-term safety profile while confirming its real-world effectiveness across diverse patient populations. The data particularly highlights the medication's utility in specialized clinical scenarios, including perioperative management and contact lens-related dry eye.
