Clinical Scorecard: Motugivatrep may be well tolerated at 1 year

At a Glance

Key Highlights

• In this open-label, single-arm phase 3 study, 162 adults received motugivatrep 0.3% four times daily for 52 weeks, alone or with selected existing dry eye therapies.
• Treatment-emergent adverse events occurred in 45% of patients; treatment-related adverse events occurred in 15% and were mostly mild.
• No severe or serious treatment-related adverse events or deaths were reported; three serious adverse events were considered unrelated to treatment.
• Patient-reported symptoms and several ocular surface measures improved during treatment, while tear secretion decreased from baseline.
• The uncontrolled, unmasked design and study population limit attribution of improvements to motugivatrep and generalizability.

Guideline-Based Recommendations

Diagnosis

• Study eligibility required dry eye disease symptoms for at least 6 months and prespecified criteria for symptom severity and tear break-up time.

Management

• The study regimen was one drop of motugivatrep 0.3% in each eye four times daily for 52 weeks, as monotherapy or alongside diquafosol sodium, rebamipide, or sodium hyaluronate.
• The study was not designed to establish comparative efficacy between monotherapy and combination therapy or among concomitant medications.

Monitoring & Follow-up

• Safety assessments included treatment-emergent and treatment-related adverse events, ophthalmic examinations, vital signs, and laboratory testing.
• Clinical assessments included DEQS, eye-dryness visual analog scores, 5-item Dry Eye Questionnaire, corneal and conjunctival fluorescein staining, tear break-up time, and tear secretion.

Risks

• Three patients discontinued treatment because of treatment-emergent adverse events; one discontinuation involved events considered treatment-related.
• One patient receiving combination therapy experienced three moderate treatment-related adverse events that resolved after treatment discontinuation.
• The study had no concurrent comparator, and unmasked symptom assessments and possible medication washout before baseline may have influenced observed changes.

Patient & Prescribing Data

The study enrolled 162 adults in Japan with dry eye disease lasting at least 6 months; 149 completed treatment. Most had relatively mild corneal staining at baseline.

Patients used one drop in each eye four times daily for 52 weeks. Of the 162 patients, 105 received monotherapy and 57 received concomitant diquafosol sodium, rebamipide, or sodium hyaluronate. The study reported tolerability and clinical outcomes but cannot establish comparative efficacy.

Clinical Best Practices

• Interpret symptom and ocular-surface improvements in light of the study's open-label, single-arm design and lack of a concurrent comparator.
• Consider that the study population was limited to patients enrolled in Japan and that most had relatively mild corneal staining at baseline.
• Do not infer comparative efficacy among motugivatrep monotherapy, combination therapy, or the individual concomitant medications from this study.

Related Resources & Content

• Clinical Ophthalmology study described in the source article