ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today highlighted results from the Company's REMURA™ (bromfenac ophthalmic solution for dry eye) Phase 2 clinical study. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (p<0.001) as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining (p<0.01) as compared to baseline. In addition, patients achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index (OSDI) (p<0.001) and in patients' most bothersome ocular symptoms. Patients treated with REMURA maintained the improvements in the signs and symptoms of dry eye disease for 10 days after discontinuing treatment, which was evaluated at the time of the follow up visit. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.
These results were presented in poster sessions at the 6th International Conference on the Tear Film & Ocular Surface in Florence, Italy, in poster presentations titled "Bromfenac Ophthalmic Solution for Treating the Signs of Dry Eye Disease" and "Alleviation of Dry Eye Disease Symptoms with Bromfenac Ophthalmic Solution."
ISTA's REMURA Phase 2 study enrolled 38 patients who exhibited signs and symptoms consistent with moderate dry eye disease. The study was designed to investigate the effects of REMURA compared to baseline on the objective signs of conjunctival staining (Lissamine Green test) and corneal staining (Fluorescein test), as well as subjective symptoms (OSDI and patients' most bothersome ocular symptoms), when administered under normal environmental conditions. All patients received REMURA in both eyes, twice daily, for 42 days. Patient baseline scores were recorded prior to the first treatment with REMURA and were compared to scores at Day 14, Day 42 and Day 52.
Authors of the posters were Simon P. Chandler, Ph.D., James A. Gow, M.D. and Timothy R. McNamara, Pharm.D. of ISTA Pharmaceuticals, Inc., Irvine, CA, USA; Sheri L. Rowen, M.D., of the Mercy Medical Eye and Cosmetic Surgery Center, Baltimore, MD, USA; and Neal A. Sher, M.D., F.A.C.S., Partner, Eye Care Associates, Minneapolis, MN, USA.
ISTA recently announced the Company has initiated its REMURA Phase 3 clinical study program. Two Phase 3 studies to evaluate the efficacy and safety of REMURA are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA), and two remaining Phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. ISTA anticipates starting the remaining safety studies later this year and reporting results for the first two Phase 3 efficacy and safety studies in the middle of 2011.