Lifitegrast Ophthalmic Solution 5.0% for Treatment of Dry Eye Disease

Clinical and Molecular Inflammatory Response in Sjögren Syndrome–Associated Dry Eye Patients Under Desiccating Stress

“…Our study outcomes provide further evidence supporting current industry efforts to develop new therapeutics for ameliorating exacerbation episodes of dry eye patients. 11,29 Moreover, these treatments should also target the increased inflammatory activity previously shown by tear molecule concentrations 29 and supported by these results. Finally, this study supplies additional evidence that artificially controlled environments can be valuable clinical trial tools 25,15 because they permit regulating exposure conditions, thus overcoming habitual clinical trial shortcomings.…”

“…1,2 With the aim of better understanding the disease and better showing dry eye therapeutics efficacy, customized instruments and facilities where environmental conditions can be controlled have been designed. [11][12][13][14][15] In the present study, we used our own facility (Controlled Environmental Research Laboratory) 13,25 and observed that the lacrimal functional unit status in SS dry 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 López-Miguel et al -7 eye patients worsened after undergoing short-term desiccating conditions. This clinical deterioration was accompanied by significant changes in the activity of several tear molecules (IL-1RA, IL-6, IL-8, and MMP-9) previously reported to be elevated in patients with dry eye as compared to healthy subjects.…”

“…Therefore, our research group and others have studied the clinical and tear changes occurring in dry eye patients after exposing them to several desiccating conditions to evaluate how the lacrimal functional unit responds to a controlled adverse environment. [11][12][13][14][15] However, we were not able to find in the literature reports addressing the variation of tear molecules occurring only in SS-associated dry eye patients when being exposed to controlled adverse conditions in spite of the following two well-known facts: first, inflammation plays a major role in dry eye disease, 2 and second, concentrations of some tear molecules in severe dry eye patients are consistently different from healthy subjects. [16][17][18][19] The analysis of the changes occurring in tear molecules of SS dry eye patients could be interesting from a therapeutic viewpoint, 20 because this biochemical assessment could provide information regarding the mechanism of the acute exacerbations that these severe dry eye patients frequently suffer.…”

Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials

“…The results of three randomized controlled trials investigating the clinical efficacy and safety of lifitegrast ophthalmic solution for the treatment of DED have been reported to date (one phase 2 and two phase 3 trials [OPUS-1 and OPUS-2]) [9][10][11] . These three multicenter, randomized, placebo-controlled trials were carried out in the US over a period of 4 years between 2009 and 2013, and involved over 1500 participants.…”

“…The phase 2 trial 9 evaluated the efficacy of lifitegrast ophthalmic solution (0.1%, 1.0%, and 5.0%) compared with placebo on signs of DED in participants with mild-to-moderate baseline symptomatology. The first phase 3 trial, OPUS-1 10 , evaluated the effect of lifitegrast ophthalmic solution 5.0% on signs and symptoms of DED in a larger population of participants with mild-to-moderate baseline DED symptomatology. OPUS-2 11 , a subsequent phase 3 trial, investigated the effect of lifitegrast ophthalmic solution 5.0% in participants with moderate-to-severe DED symptomatology.…”