PURPOSE: To document patient characteristics, diagnostic tests, and treatment of dry eye disease (DED) in patients outside of the clinical trial setting, leveraging real-world evidence (RWE).

METHODS: Retrospective cohort study using the American Academy of Ophthalmology IRIS® (Intelligent Research in Sight) Registry linked to pharmacy claims data. Patients were diagnosed with DED and initiated an index lifitegrast DED prescription therapy between Jan 1, 2017, and Dec 31, 2024.

RESULTS: Study included 143,005 patients who initiated lifitegrast DED therapy (mean age, 61 y; 80% female). Ocular comorbidities included cataracts (41%), glaucoma (9%), and age-related macular degeneration (5%). Non-ocular included hyperlipidemia (45%), hypertension (43%), diabetes (21%), obstructive sleep apnea (11%), chronic obstructive pulmonary disease (6%) rheumatoid arthritis (6%) and Sjögren's syndrome (6%). About 7% of eyes (n=19,654) had recorded tear film break-up time measurements, 2% (n=4877) had Schirmer's, and 11% (n=29,830) had tear osmolarity tests. Prior to index therapy, 11% of patients had received a prescription (predominantly topical cyclosporine 0.05%); 8% punctal plugs.

CONCLUSION: This large RWE study shows that patients with DED often have significant ocular and systemic comorbidities. Diagnostic testing remains underutilized, highlighting practice gaps and informing future strategies to improve diagnosis and treatment.