Efficacy of HL036 versus Cyclosporine A in the Treatment of Naturally Occurring Canine Keratoconjunctivitis Sicca

ABSTRACT

Purposes: To (i) evaluate the efficacy and safety of HL036, a tumor-necrosis factor (TNF)-α-blocking protein, in the treatment of naturally occurring canine keratoconjunctivitis sicca (KCS) and (ii) compare these features with those of 1% cyclosporine A (CsA).

Materials and Methods: Dogs (n = 29) diagnosed with KCS were randomly assigned to receive one drop topical aqueous HL036 (0.2, 1, or 5 mg/mL) or 1% CsA in the affected eye(s) at 12-h intervals for 42 days. Schirmer’s tear test (STT), fluorescein corneal staining (FCS), and clinical-sign scores were evaluated prior to application (day-0) and on days 14, 28, and 42 post-treatment. Of the 29 dogs enrolled, 19 (65.5%) received HL036 (HL036 group) and 10 (34.5%) received 1% CsA (CsA group). A linear mixed-effects model analysis was performed to determine score differences between groups and over time.

Results: After treatment, clinical-sign scores and STT values had significantly improved compared with baseline levels in dogs of both treatment groups. Decreases in total clinical-sign scores for the HL036-group were greater than those of 1% CsA group. No severe adverse reactions were noted in either group.

Conclusions: Our findings suggest that topical aqueous HL036 is well-tolerated and more effective than 1% CsA for treating naturally occurring canine KCS.

KEYWORDS:

• Canine keratoconjunctivitis sicca
• dry eye disease
• HL036
• TNF-α blocker
• cyclosporine A

Declaration of interest

The authors report no conflicts of interest.

Additional information

Funding

This study was supported by grants from the Korean Health Technology Research and Development Project, Ministry of Health and Welfare, Republic of Korea [grant numbers: HI10C2014 and HI06C0868] and Industrial Strategic Technology Development Program [project no. 10040233, molecular engineering and drug development of anti-TNF antibody fragment for local inflammatory diseases] funded by the Ministry of Knowledge Economy (Korea).