Clinical ophthalmology
Long-Term Safety and Clinical Outcomes of Motugivatrep (SJP-0132) 0.3% Ophthalmic Suspension in Patients with Dry Eye Disease: An Open-Label, Phase 3 Study
By Hori Y, Wada T, Omatsu K and 3 others.
Abstract
Purpose
To evaluate the long-term safety and clinical outcomes of motugivatrep (SJP-0132) 0.3% ophthalmic suspension in patients with dry eye disease (DED). Patients and methods: In this open-label, multicenter, 52-week Phase 3 study, patients aged ≥18 years with a ≥6-month history of DED, at least one question scored ≥1 on the Dry Eye-related Quality-of-Life Score questionnaire, eye dryness Visual Analog Scale score ≥40, 5-item Dry Eye Questionnaire score ≥6, and tear break-up time ≤5 seconds received motugivatrep 0.3% (1 drop/eye) four times daily for 52 weeks, as monotherapy or in combination with diquafosol sodium, rebamipide, or sodium hyaluronate. Primary endpoints were the incidence and severity of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs).
Results
In the safety analysis set (n=162; monotherapy, n=105; combination, n=57), TEAEs occurred in 45.1% of patients overall (monotherapy 39.0%, combination 56.1%), and TRAEs in 14.8% overall (12.4%, 19.3%). All TRAEs were mild except for three moderate nonocular events in a single patient receiving combination therapy; these recovered/resolved without additional medication after treatment discontinuation. The most common ocular and nonocular TRAEs were eye discharge (3.1%) and feeling cold (7.4%), which also recovered/resolved. Changes from baseline were generally favorable across subjective symptom measures and objective signs, regardless of monotherapy or combination therapy.