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First Author: C.Semba USA
Co Author(s): J. Sheppard
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Dry eye is a chronic and debilitating disease that can adversely affect a patients quality of life. Chronic inflammation is widely accepted as central to the perpetuation and exacerbation in all types of the disease. Despite the overwhelming prevalence of dry eye and resulting increased costs to the healthcare system, there are very few effective therapies. Treatment with over-the-counter artificial tears currently accounts for the majority of disease management. Artificial tears provide symptomatic and palliative relief but do not address the underlying chronic inflammation. There is a significant unmet medical need for a therapeutic agent that can rapidly treat both the signs and symptoms of dry eye. Lifitegrast (LIF) is a novel integrin antagonist developed to potently and specifically block a key interaction in the chronic T-cell mediated inflammatory cycle associated with dry eye. In a pivotal Phase 3 randomized, controlled, multi-center study called OPUS-1, lifitegrast ophthalmic solution 5.0% demonstrated improvements in signs and symptoms of dry eye disease. The purpose was to evaluate a sub-population of subjects actively using artificial tears (AT) prior to randomization.
Multicenter, prospective, randomized, double-masked, placebo-controlled study.
588 dry eye subjects were randomized 1:1 to receive LIF (5.0%) or placebo eye drops twice daily (BID) for 84 days. Eligibility criteria included demonstration of exacerbation in corneal staining and ocular symptoms when challenged in a desiccating chamber, no active lid margin disease, and Schirmers score (unanesthetized, (mm/5 min) of ? 1 and ? 10 mm. A pre-specified efficacy analysis was conducted on the sub-population of subjects with history of recent AT use, defined as use within 30 days prior to first screening visit. Endpoints evaluated included objective signs (corneal fluorescein staining, lissamine staining), and subjective symptoms (ocular discomfort score (Ora scale)), 7-item visual analogue scale (VAS)).
A total of 257 subjects who had previously used artificial tears were analyzed (128 LIF, 129 placebo) and represents 43.7% of the total study population. Subjects on LIF 5.0% demonstrated superiority in inferior corneal staining (P=0.0142) and nasal lissamine staining scores (P=0.0128) compared to placebo at Day 84. As early as Day 42, there was a significant difference in the change from baseline in nasal lissamine scores between LIF 5.0% and placebo (P=0.0455). Correspondingly, symptom relief was also significant in the LIF group for ocular discomfort (P=0.0001) and for the VAS items of eye dryness (P=0.0012), foreign body sensation (P=0.0250), and pain (P=0.0205). Significant improvement was observed for the LIF 5.0% group in the ocular discomfort score as early as Day 14 (P=0.0179) and was maintained through Day 84. Lifitegrast appeared safe and well-tolerated. Adverse events were primarily instillation site complaints on Day 0.
In dry eye subjects who exhibited ocular surface damage and symptoms despite previous artificial tear use, lifitegrast ophthalmic solution 5.0% demonstrated superiority compared to placebo in amelioration of corneal and conjunctival staining, typical hallmarks of the damage caused by chronic dry eye. Subjects using lifitegrast also experienced rapid symptom relief, occurring as early as Day 14. These results in subjects who have previously used artificial tears are consistent with and, in most cases, more significant than in the total study population. Lifitegrast is a small molecule integrin antagonist that blocks a key step in the inflammatory cascade, and has demonstrated significant improvements in both signs and symptoms of dry eye disease. This novel therapy may provide more rapid and significant relief, especially in patients who have not been able to control their disease with artificial tear use.
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