Summary
PURPOSE: Dry eye disease (DED) is a multifactorial disease, with a subset of etiologies associated with inflammation. Lifitegrast ophthalmic solution 5% is a lymphocyte function- associated antigen-1 (LFA-1) antagonist approved for the treatment of DED. A post hoc analysis of phase 3 lifitegrast studies (OPUS-2 and OPUS-3) identified a subset of patients who had rapid, robust, and sustained improvement in DED symptoms. Real-world studies can further clarify the clinical characteristics of treatment responders. This first phase of a 3-part study explored eye care provider (ECP) definitions of “robust responders” to lifitegrast treatment based on patient characteristics and clinical findings.
METHODS: A series of semi-structured qualitative interviews were conducted with US ECPs. Interview questions pertained to ECP experience with lifitegrast, definition of a robust response, and patient and clinical characteristics associated with the quality of response. Transcripts were analyzed thematically to identify recurring concepts and clinically relevant insights.
RESULTS: Ten experienced ECPs (ophthalmologists and optometrists) who routinely treat patients with DED and prescribe lifitegrast were interviewed. Although the definition of a robust responder to lifitegrast treatment differed across ECPs, ≥1 common feature(s) described by 7 of 10 ECPs included improvement or reduction in DED symptoms within 4 to 6 weeks and a reduction in ocular surface staining. Inflammation was viewed as central to treatment by 5 ECPs, with robust responders frequently described as having positive inflammatory markers, aqueous- deficient dry eye, or inflammatory meibomian gland dysfunction. Other commonly cited patient characteristics included peri- or postmenopause (women), comorbid autoimmune or systemic inflammatory disease (eg, Sjögren’s syndrome, rheumatoid arthritis), positive MMP-9, high digital screen use, and contact lens intolerance or postsurgical dry eye. Improvements in quality of life and functional vision were also identified as key indicators of robust response.
CONCLUSION: Eye care providers identified a clinically meaningful subset of patients with DED who showed robust response to lifitegrast, largely driven by inflammation-mediated disease. These qualitative findings will inform subsequent real-world studies to further characterize robust responders using objective clinical data.