Clinical Scorecard: Revisiting Lifitegrast in Dry Eye Disease

At a Glance

Key Highlights

• Across the OPUS phase 3 trials, effects on signs and symptoms varied: OPUS-1 improved inferior corneal staining, while OPUS-2 and OPUS-3 demonstrated improvement in eye dryness.
• In OPUS-2 and OPUS-3, eye-dryness improvement was apparent by day 14; OPUS-3 reported improvement at later assessments as well.
• The most common ocular adverse events were instillation-site irritation, reaction, and pain; dysgeusia was the most frequent nonocular event.
• Real-world reports generally supported trial findings for symptoms, signs, and quality of life, while treatment persistence remained a challenge.
• The review describes emerging use before cataract surgery, associated with improved keratometry reproducibility and refractive accuracy.

Guideline-Based Recommendations

Diagnosis

• The review describes DED assessment using clinical signs and patient-reported symptoms; it notes that these outcomes may not closely correspond in this heterogeneous disease.

Management

• Lifitegrast ophthalmic solution 5% is indicated for treatment of both signs and symptoms of DED.
• The review positions lifitegrast as one component of a personalized DED treatment landscape; it does not provide a specific treatment algorithm.

Monitoring & Follow-up

• Clinical trials assessed corneal staining and eye dryness; the real-world case series also reported tear osmolarity, Schirmer testing, tear breakup time, and staining.
• The review reports that treatment persistence can be challenging.

Risks

• Common ocular adverse events included instillation-site irritation, reaction, and pain.
• Dysgeusia occurred in 14.5% of lifitegrast-treated patients versus 0.3% receiving vehicle in the reviewed trial safety data.
• The review reports that overall discontinuation because of adverse events was relatively low.
• The review had Bausch + Lomb-funded medical writing assistance; its authors included company employees, and several others reported consultancy relationships.

Patient & Prescribing Data

Patients with DED treated in clinical trials and real-world reports; the article identifies lifitegrast 5% as indicated for DED signs and symptoms.

Three 12-week phase 3 OPUS trials provided much of the efficacy evidence. In a prospective case series, mean OSDI improved from 52.2 at baseline to 31.2 after 12 weeks, alongside reported improvements in tear osmolarity, Schirmer testing, tear breakup time, and staining.

Clinical Best Practices

• Consider both patient-reported symptoms and clinical signs when evaluating DED; the review notes that they may diverge.
• When interpreting lifitegrast evidence, distinguish symptom outcomes from sign outcomes across individual trials.
• Consider the reported adverse-event profile and treatment persistence when reviewing real-world use.
• Interpret the review's conclusions in light of its disclosed industry funding and author relationships.

Related Resources & Content

• Revisiting Lifitegrast in DED — review in Expert Review of Ophthalmology (URL not provided)