Lifitegrast ophthalmic solution in the treatment of signs and symptoms of dry eye disease: design, development, and place in therapy

Figures & data

Figure 1 Timeline of lifitegrast studies.

Notes: All OPUS studies were Phase III. Dates represent patient enrollment periods. The Phase II and OPUS-1 studies provided statistically significant evidence of improvement in a sign of dry eye due to lifitegrast; OPUS-2 and OPUS-3 provided evidence of improvement in a symptom of DED. All trials were conducted for 84 days in adult patients with DED.
Abbreviation: DED, dry eye disease.

Table 1 Incidence of most frequent TEAEs (>5% of participants in either treatment group) in the SONATA study

TEAEs	Vehicle n (%)	Lifitegrast 5% n (%)
Instillation site irritation/burning	5 (4.5%)	33 (15.0%)
Mild	4	26
Moderate	1	6
Severe	0	1
Instillation site reaction	2 (1.8%)	29 (13.2%)
Mild	2	22
Moderate	0	6
Severe	0	1
Visual acuity reduced	7 (6.3%)	25 (11.4%)
Mild	6	23
Moderate	1	2
Severe	0	0
Dry eye	6 (5.4%)	4 (1.8%)
Mild	2	3
Moderate	3	1
Severe	1	0
Dysgeusia	2 (1.8%)	36 (16.4%)
Mild	2	32
Moderate	0	4
Severe	0	0

Notes: Data from Donnenfeld et al.¹⁵

Abbreviations: TEAE, treatment-emergent adverse events; SONATA, Safety Of a 5.0% coNcentrATion of lifitegrAst ophthalmic solution.

DonnenfeldEDKarpeckiPMMajmudarPASafety of lifitegrast ophthalmic solution 5.0% in patients with dry eye disease: a 1-year, multicenter, randomized, placebo-controlled studyCornea201635674174827055211

 PubMed Web of Science ®Google Scholar