Hot topics in dry eye and glaucoma
By Gretchyn M. Bailey NCLC FAAO Editor in Chief Content Channel Director,Colleen E. McCarthy
New Orleans—Leaders in their respective specialties came together at the American Academy of Optometry 2015 meeting in New Orleans to share their latest research in dry eye and glaucoma.
Hot topics in dry eye focused on study results from lifitegrast, Shire’s dry eye therapy pending FDA approval; Refresh Optive Gel Drops, Allergan’s newest rewetting drop with glycerin; and MiboFlo, MiBo Medical Group’s lid massager.
Optometry Times Editorial Advisory Board member Walter O. Whitley, OD, FAAO, summarized three randomized trials for lifitegrast. The drug is a small molecule integrin antagonist that interferes with binding of ICAM-1 to the integrin LFA-1 on the T-cell surface, inhibiting T cell recruitment and activation associated with dry eye disease.
Learning from Study 1: Met pre-specified sign endpoint, mean change from baseline to day 84 in inferior corneal staining score (ICSS) and there was a dose-response relationship for signs and symptoms of dry eye with greatest efficacy for 5.0% solution vs. 0.1% and 1.0%.
Learning from Study 2: Met the sign (ICSS) but not the symptom co-primary endpoint. Lifitegrast effect on ICSS was more pronounced in less symptomatic subjects.
Learning from Study 3: Lifitegrast significantly improved eye dryness score and all pre-specified secondary symptom endpoints achieved statistical significance. Lifitegrast failed to separate sign endpoint from placebo in the more symptomatic population.
As in previous dry eye disease (DED) research, outcomes for signs and symptoms of DED are poorly correlated in lifitegrast clinical trials.
For the eye dryness score, there may be a “floor effect,” as seen in Study 2, in which efficacy can be demonstrated only when baseline symptoms are sufficiently severe. In contrast, subjects with high baseline ICSS grades may have underlying conditions not responsive to a short course of treatment, or there may be difficulties in grading the inferior corneal staining score (ICSS).
Because of the paradoxical relationship between signs and symptoms of DED observed in the lifitegrast trials, it may not be possible to achieve statistical success with the coprimary endpoints (signs and symptoms) in the same study……
Source: Optometry Times