Novel Therapy for Allergic Conjunctivitis Patients Using Ebi-005, a Topical Intereukin-1 Receptor Inhibitor
Purpose
Although many allergic conjunctivitis (AC) patients are well controlled, large numbers are inadequately treated or require steroids. EBI-005 is being developed for moderate to severe AC. This study’s objectives were to assess safety and biological activity of EBI-005 in AC, and to evaluate two clinical models for this indication.
Methods
In this randomized, double-masked, vehicle-controlled study, patients with moderate to severe allergic conjunctivitis were randomized to topical EBI-005 or vehicle and repeatedly challenged with allergen using an adaptation of two clinical models for studying allergic conjunctivitis. Subjects were assigned to one of two models of allergic conjunctivitis, either repetitive challenges with a direct conjunctival allergen challenge (Conjunctival Allergen Provocation Test, CAPT) or repetitive aerosolized challenge in an allergy chamber (Environmental Exposure Chamber, EEC). For each model, subjects were randomized to topical EBI-005 3x/day or vehicle-control for up to 18 days. 159 subjects were enrolled in this study.
Results
EBI-005 was well tolerated with no treatment-related serious adverse events and no immunogenicity detected. In the CAPT, EBI-005 treated patients showed statistically significant improvements in mean change from baseline in ocular itching compared with vehicle at Days 18 (p =.033) and 19 (p =.045), respectively. These subjects also improved compared to vehicle treatment with statistically significant reductions of ocular tearing (p=.027 and p=.044) and nasal symptoms (p=.004 and p=.011) at Days 18 and 19 respectively. In the EEC, there were no observed differences between patients treated with EBI-005 and vehicle on itching, ocular tearing or associated nasal symptoms.
Conclusion
These results support the use of an adapted, multiple-challenge, CAPT model to assess the efficacy of EBI-005 in the late phase AC response. In this clinical model, EBI-005 was well tolerated, and showed statistically significant improvements in ocular itching, tearing, and nasal symptoms in patients with moderate to severe AC.