Highlights of dry eye Phase 2 clinical study revealed

ISTA Pharmaceuticals has highlighted results from its Phase 2 clinical study on Remura dry eye solution. According to the company, the study showed improvements in conjunctival and corneal staining as well as alleviating other bothersome ocular symptoms. Improvements in signs and symptoms of dry eye disease were reported to continue for 10 days after discontinuing treatment.

The phase 2 study enrolled 38 patients with signs and symptoms consistent with dry eye and monitored the effects that the solution had on these. Patients received the solution under normal conditions in both eyes, twice a day for 42 days. Conjunctival staining, monitored by the Lissamine Green test, was shown to have improved compared to the baseline, as was corneal staining (monitored by the Fluorescein test). Additionally, improvements in subjective symptoms were reported, based on results from the Ocular Surface Disease Index as well as in patients' most bothersome ocular symptoms.

These results were presented during poster sessions at the 6th International conference on Tear film & Ocular Surface in Florence, Italy.

The company has now announced that it will begin a Phase 3 clinical study programme later this year and expect to report initial results in the middle of 2011.