Safety and efficacy of risuteganib ophthalmic solution in the treatment of dry eye disease: A prospective, randomized, double-masked, vehicle-controlled study

Abstract

Objectives: The aim of the study was to compare the safety and efficacy of ALG-1007 (0.125% sodium hyaluronate [SH] + 0.6% risuteganib [RSG] ophthalmic solution) to 0.6% RSG alone, 0.125% SH alone, and vehicle alone in subjects with dry eye disease (DED). Material and Methods: Eligible participants aged ≥18 years old with symptoms of DED for ≥ 6 months were randomized into four treatment groups: ALG-1007, RSG, SH, and vehicle. The treatment for all groups was administered one drop twice a day and subjects were evaluated at weeks 2, 4, 8, and 12. Primary efficacy endpoints were change in nasal conjunctival staining and change in Dry Eye Management Scale (DEMS) score from baseline to week 12. Secondary efficacy endpoints were changes in tear breakup time (TBUT), total ocular staining (TOS), inferior corneal staining score, and individual and combined reported symptoms by Visual Analog Scale (VAS), from baseline to week 12. Results: All parameters tested and analyzed – nasal conjunctival staining, DEMS, TBUT, inferior corneal staining score, and VAS (combined, burning, discomfort, dryness, foreign body sensation, and photophobia) – improved in all study groups over the 12-week observation period. The greatest improvements in all parameters tested were seen in the ALG-1007 group followed by RSG only, SH only, and then vehicle. Comparison of 12-week change from baseline (CFB) values demonstrated statistically significant differences in all group comparisons for all the measurements done except for comparison of ALG-1007 versus RSG (P = 0.3154) for nasal conjunctival staining. No adverse events were reported. Conclusion: 0.60% RSG topical ophthalmic solution was effective in improving the signs and symptoms of DED and demonstrated therapeutic properties. ALG-1007, a combination of 0.60% RSG + 0.125% SH, was superior to RSG alone and will provide the most therapeutic benefit to patients with DED. ALG-1007 and RSG were well-tolerated with no drug-related AEs or SAEs reported over a 12-week observation period.