Objective:

Assess the 52-week safety and clinical outcomes of motugivatrep 0.3% ophthalmic suspension, used alone or with existing dry eye therapies, in adults with dry eye disease.

Approach:

• Design and participants: Multicenter, open-label, single-arm phase 3 study at 22 clinics in Japan; 162 adults enrolled and 149 completed treatment.
• Treatment: Participants used one drop in each eye four times daily for 52 weeks. Of these, 105 received motugivatrep alone and 57 received it with diquafosol sodium, rebamipide, or sodium hyaluronate.
• Assessments: Primary outcomes were the incidence and severity of treatment-emergent and treatment-related adverse events. Assessments also included patient-reported symptoms and ocular surface measures.

Key Findings:

• Treatment-emergent adverse events occurred in 73 patients (45%); treatment-related adverse events occurred in 24 (15%). Most treatment-related events were mild, and none were severe or serious.
• Three patients had serious adverse events, all judged unrelated to treatment; no deaths occurred. Three patients discontinued because of adverse events, including one with treatment-related events.
• Patient-reported symptoms improved early and remained below baseline through week 52. Mean DEQS total score decreased by 22.18 points from a baseline of 37.61.
• Corneal fluorescein staining and conjunctival staining improved, and tear break-up time increased. Tear secretion decreased from baseline.
• The authors reported no clinically meaningful changes in ophthalmic examinations, vital signs, or laboratory measures.

Interpretation:

The authors reported that motugivatrep 0.3% used four times daily was well tolerated over 52 weeks, with clinical outcomes consistent with a treatment effect when used alone or with standard dry eye therapies.

Limitations:

• The open-label, single-arm design had no concurrent placebo or active comparator, so symptom improvements cannot be definitively attributed to motugivatrep.
• Unmasked symptom assessments and possible effects of medication washout before baseline may have influenced observed changes.
• Participants were enrolled in Japan, and most had relatively mild corneal staining at baseline, which may limit generalizability.
• Combination-therapy subgroups were small, and the study was not designed to compare treatment approaches.

Sources:

• Clinical Ophthalmology (study source named in article context)