Reduction of Artificial Tears and Use of Adjunctive Dry Eye Therapies After Lifitegrast Treatment: Evidence from Clinical and Real-World Studies

Kelly K Nichols,1 Eric D Donnenfeld,2 Charis Lau,3 Annie Syntosi,4 Paul Karpecki,5 John A Hovanesian6,7 1School of Optometry, University of Alabama at Birmingham, Birmingham, AL, USA; 2New York University Medical Center, New York, NY, USA; 3Retina Global Medical Affairs, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 4Retina Global Patient Access, Novartis Pharma AG, Basel, Switzerland; 5Kentucky Eye Institute, Lexington, KY, USA; 6Harvard Eye Associates, Laguna Hills, CA, USA; 7UCLA Jules Stein Eye Institute, Los Angeles, CA, USACorrespondence: John A Hovanesian, Harvard Eye Associates, 24401 Calle de la Louisa, Suites 300-312, Laguna Hills, CA, 92653, USA, Tel +1 949-742-3937, Fax +1 844-479-0584, Email johnhova@gmail.com; jhovanesian@HarvardEye.comPurpose: To assess the frequency of patients reducing the use of artificial tears (ATs) among patients with dry eye disease (DED) following lifitegrast treatment.Patients and Methods: Two independent analyses were performed using the data from the 1-year, randomized, multicenter, Phase 3 SONATA trial and a noninterventional, real-world evidence (RWE) study conducted in patients with DED who were treated with lifitegrast in the United States and Canada. In SONATA, patients who had used ATs in the lifitegrast and placebo groups were included. The RWE study reviewed patients’ electronic medical records, prescribing patterns, and practices of physicians throughout the survey. These data were then used to compare the proportion of patients using ATs in the 6-month pre-index period versus the 12-month post-index period.Results: Of 293 patients (lifitegrast, n=195; placebo, n=98) from SONATA, 107 (lifitegrast, n=64; placebo, n=43) used ATs during the on-therapy period while 186 (lifitegrast, n=131; placebo, n=55) did not. Of those not using ATs, the proportion of patients in the lifitegrast group at any time was higher (∼ 67% [n=131]) versus placebo (∼ 56% [n=55]); this was the case at all study time-points (Days 90, 180, 270, and 360). The RWE study included 600 patient charts (US, n=550; Canada, n=50); 75.5% (n=453) reported AT use. There was ∼ 40% decrease in the proportion of patients using ATs as adjunct DED therapy to lifitegrast in the post-index period (n=273) versus those in the pre-index period (n=453).Conclusion: The findings show that the reliance on AT use can be gradually reduced with lifitegrast treatment, eventually leading to a reduction in disease burden.Keywords: dry eye disease, lifitegrast, artificial tears, SONATA, real-world evidence, chart review