In patients with severe dry eye disease (DED), topical licaminlimab, an antitumor necrosis factor α agent can improve ocular discomfort compared with the drug vehicle. These findings, from a randomized, phase II study, were published in Clinical Ophthalmology.
This study was conducted at 26 sites in the United States. Patients with persistent, frequent, and severe ocular discomfort without relief from artificial tears at day 15 were given the drug vehicle for 4 weeks. At 4 weeks, patients with global ocular discomfort scores of 50 or higher were randomized to receive licaminlimab (n=69) or the study vehicle (n=65) for 6 weeks. Licaminlimab and the vehicle were administered as 3 drops per day. The primary efficacy endpoint was change in global ocular discomfort score at treatment day 29, as a composite of frequency and severity according to the Symptom Assessment iN Dry Eye (SANDE) questionnaire.
The intervention and control cohorts were aged median 60 (range, 24-90) and 61 (range, 22-86) years, 88.4% and 83.1% were women, and 73.9% and 80.0% were White, respectively.
Global ocular discomfort scores decreased by 7.9 points among the intervention and 3.6 points among the control cohorts. The change from baseline was significantly greater among the intervention cohort (mean difference [MD], -4.3; 90% CI, -7.7 to -0.8; P =.041).
Significantly more licaminlimab recipients achieved a 20-unit or greater improvement in global ocular discomfort score from baseline (17.9% vs 4.7%; P =.018).
The proportion of patients reporting at least 1 treatment-emergent adverse event (TEAE) was 18.8% among the intervention and 13.8% among the control cohorts. In addition, there was 1 serious TEAE in the control group and one discontinuation due to TEAE among the intervention group. In the intervention cohort, 2 events were related with the study drug.
The major limitation of this study was the short study duration. Additional investigation is needed to evaluate long-term outcomes.
The study authors concluded that topical ocular licaminlimab improved ocular discomfort among patients with severe DED and was well-tolerated with no obvious systemic safety concerns.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Shettle L, McLaurin E, Martel J, Seaman JW III, Weissgerber G. Topical anti-TNFα agent licaminlimab (OCS-02) relieves persistent ocular discomfort in severe dry eye disease: a randomized phase II study. Clin Ophthalmol. 2022;16:2167-2177. doi:10.2147/OPTH.S366836