Motugivatrep (SJP-0132) 0.3% Ophthalmic Suspension for Dry Eye Disease: A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Trial.

Abstract

Purpose: To evaluate the efficacy and safety of motugivatrep (SJP-0132) 0.3% ophthalmic suspension, a novel therapy targeting subjective symptoms, in patients with dry eye disease.

Patients and methods: This pivotal, multicenter, randomized, double-masked, placebo-controlled Phase 3 study was conducted in Japan. Outpatients with dry eye-related subjective symptoms and short tear break-up times (TBUT; ≤5 seconds in both eyes) were randomized 1:1 to receive motugivatrep 0.3% ophthalmic suspension or placebo four times daily for 8 weeks. The primary endpoint was the change from baseline in total Dry Eye-related Quality of Life Score (DEQS) at week 4.

Results: A total of 535 patients were randomized to motugivatrep 0.3% (n=268) or placebo (n=267). The primary endpoint was met, with a significantly greater improvement in total DEQS at week 4 in the motugivatrep 0.3% group compared with placebo (least-squares mean [LSM] change from baseline -16.76 vs -14.36; LSM difference -2.40; 95% CI -4.72, -0.07; p=0.0433). Consistent improvements in total DEQS were observed with motugivatrep 0.3% vs placebo from week 1 through week 4 (all nominal p<0.05). Motugivatrep 0.3% also demonstrated early improvements in other subjective symptoms, with statistically significant improvements vs placebo in visual analog scale scores for eye dryness at weeks 1 and 4 (both nominal p<0.05).No significant differences were observed between groups in changes in TBUTs or corneal fluorescein staining (CFS) scores overall. A subgroup analysis suggested greater and increasing improvements in total CFS scores with motugivatrep 0.3% compared with placebo in patients with corneal epithelial disorder, indicating potential benefit in this population. Motugivatrep 0.3% was generally well tolerated, with no major safety concerns identified.

Conclusion: Motugivatrep 0.3% ophthalmic suspension provided early improvements in subjective symptoms and quality of life and was well tolerated, representing a new therapeutic option for patients with dry eye disease.