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 anti-inflammatory DED prescription therapy between Jan 1, 2017, and Dec 31, 2024.

RESULTS: The study included 143,005 patients with DED who initiated an anti-inflammatory DED therapy. The average age was 61 years, and most were female. Ocular comorbidities included cataracts (41%), glaucoma (9%), and age-related macular degeneration (5%). Non-ocular comorbidities included hyperlipidemia (45%), hypertension (43%), diabetes (21%), obstructive sleep apnea (11%), chronic obstructive pulmonary disease (6%) rheumatoid arthritis (6%) and Sjogren's syndrome (6%). Approximately 7% of patient eyes (n=19,654) had recorded tear film break-up time measurements, 2% (n=4,877) 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), and 8% punctal plugs. Clinicians included cataract/anterior segment subspeciality ophthalmologists (19%), cornea subspeciality ophthalmologists (14%), and comprehensive ophthalmologists (13%), as well as others, including optometrists (32%).

CONCLUSION: This study highlights the importance of RWE in understanding clinical characteristics, as well as diagnosis and treatment patterns, to inform future DED treatment strategies.