Data show rapid increase in tear production along with improved staining and symptoms
Results of a phase II study indicate that a novel smallmolecule integrin antagonist is a promising anti-inflammatory treatment for dry eye, said researchers at the annual meeting of the Association for Research in Vision and Ophthalmology.
The phase II study evaluating SAR 1118 was a multicentre, double-masked, placebo-controlled trial that enrolled 230 adults with bilateral keratoconjunctivitis sicca (KCS). Eligible patients had to have a Schirmer tear test (STT) result of >1 to <10 mm/5 min, no active lid margin disease, and a response with exacerbation of fluorescein corneal staining and ocular symptoms during screening using the Controlled Adverse Environment (Ora Inc.). Prior treatment with topical cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan) was allowed, but had to be discontinued for at least 6 weeks.
Inferior fluorescein corneal staining score at week 12 in the intenttotreat population was the pre-specified primary efficacy endpoint, and the results showed a dose-response effect and strong statistical trend in favor of SAR 1118. Mean reduction from baseline staining was 75% for patients treated with SAR 1% and 88% in the SAR 5% group. Doseresponse effects were also seen in analyses of STT data and Ocular Surface Disease Index (OSDI) scores. Already by the first follow-up visit at 2 weeks after random assignment, patients treated with SAR 1118 5% had a statistically significant improvement in the STT (p = 0.0392) with further improvement at 12 weeks, although the latter benefit only showed a trend to statistical significance (p = 0.0905) because STT also increased in the placebo group.