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Preeya K Gupta,1 Ian Benjamin Gaddie,2 Mitchell C Shultz,3 Patrick Vollmer,4 Steven Marc Silverstein,5 Bridgitte Shen Lee,6 Leslie O’Dell,7 Kavita Dhamdhere,7 Elizabeth Yeu7,8 1Triangle Eye Consultants, Raleigh, NC, USA; 2Gaddie Eye Centers, Louisville, KY, USA; 3Shultz Chang Vision, Los Angeles, CA, USA; 4Vita Eye Clinic, Shelby, NC, USA; 5Silverstein Eye Centers, Kansas City, MO, USA; 6Vision Optique, Houston, TX, USA; 7Tarsus Pharmaceuticals, Inc., Irvine, CA, USA; 8Virginia Eye Consultants, Norfolk, VA, USACorrespondence: Preeya K Gupta, Triangle Eye Consultants, 9650 Brier Creek Parkway, Suite 103, Raleigh, NC, 27617, USA, Tel +1 919-391-7224, Email preeyakgupta@gmail.comPurpose: To evaluate the safety and efficacy of lotilaner ophthalmic solution, 0.25% compared with vehicle in Demodex blepharitis patients with meibomian gland disease.Patients and Methods: This was a pooled analysis of two prospective, randomized, double-masked studies of Demodex blepharitis patients with meibomian gland disease, Ersa (N=39), and Rhea (N=40). The two studies had the same design, eligibility criteria, and sample size, except Ersa studied lotilaner ophthalmic solution, 0.25% while Rhea studied the associated vehicle. Study outcomes were collarette grading, meibomian gland secretion score (MGSS), number of glands yielding any liquid secretions (MGYLS), number of glands yielding clear liquid secretions (MGYCLS), patient-reported outcomes, and adverse events (AEs).Results: On Days 43 and 85, there was a statistically significantly higher proportion of patients in the lotilaner group versus the vehicle group with collarette reduction to grade 0 (0– 2 collarettes/lid) (44.7% vs 0.0% and 65.8% vs 0.0%) and grade 0 or 1 (0– 10 collarettes/lid) (81.6% vs 8.8% and 100% vs 0.0%) (all p< 0.001). Mean MGSS, MGYLS, and MGYCLS in the lotilaner group were statistically significantly higher than in the vehicle group. The proportion of lotilaner patients achieving improvement to ≥ 3 glands with clear meibum (grade 3) was ... |