PURPOSE: Lifitegrast ophthalmic solution 5% (LIF) and perfluorohexyloctane ophthalmic solution (PFHO) target distinct pathophysiologic mechanisms of dry eye disease (DED), addressing ocular surface inflammation and excessive tear evaporation, respectively. This study evaluated real-world efficacy and safety outcomes of concomitant LIF + PFHO therapy in patients with DED.

METHODS: This noninterventional, multicenter retrospective chart review (United States). Patients ≥18 years of age with a diagnosis of DED who were treated concomitantly with LIF + PFHO without receiving any other prescription DED therapy during LIF + PFHO use were included. Extracted data included demographics, DED characteristics, treatment initiation (simultaneous vs additive), clinical symptoms (evaluated on a 0-3 rating scale) and signs (eye redness, fluorescein, and lissamine green staining on a 0-3 rating scale; other endpoints by quantitative measure), and adverse events (AEs). Data were collected at the index (baseline) visit, first follow-up visit, and last available follow-up visit. Data are expressed as mean (SD).

RESULTS: Sixty-eight patients (mean [range] age: 61 [30-80] years) from 23 clinicians were included. At the index visit, 52% of patients had moderate DED, 71% had mixed-mechanism DED, while Meibomian gland dysfunction was reported in 49% of charts. Patients were treated with 4.5 (2.7) treatments (prescription, over-the-counter, and/or procedural) prior to initiating the concomitant LIF + PFHO therapy.] 43% of patients received LIF first, 22% of patients received PFHO first, whilst 35% of patient received LIF and separately PFHO at the same visit. Most common baseline symptoms were eye dryness, blurry or fluctuating vision, burning/stinging, and impairment of daily activities. Eye dryness was reduced from 2.1 (0.6) to 0.8 (0.8) and 0.5 (0.7) at the first and second follow-up visits (P<0.001 for both). Patients also experienced significant reductions in all other patient-reported symptoms. Improvements were observed in fluorescein staining (1.9 [0.7] to 0.8 [0.8] and 0.6 [0.6]) at the first and second follow-up visits (P<0.001 for both). Concomitant therapy also resulted in significant improvements in lissamine staining, conjunctival redness, tear break-up time, and tear osmolarity. No unexpected AEs were reported; 19 AEs occurred in 13 patients, the majority of which were mild to moderate in severity. Most (84%) of patients remained on concomitant therapy after their last follow-up visit.

CONCLUSION: In this real-world analysis, patients with DED experienced substantial improvements in symptoms, daily functioning, and clinical signs with concomitant LIF + PFHO therapy. Concomitant therapy was well tolerated, with no unexpected safety findings.