Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution: An 8-Weeks Phase III Study

Piotr Kuna,1 Marek Jutel,2,3 Grazyna Pulka,4 Slawomir Tokarski,5 Paula Arranz,6 Gonzalo Hernández,6 Nieves Fernández Hernando6 1Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland; 2Department of Clinical Immunology, Wroclaw Medical University, Wrocław, Poland; 3All-Med Medical Research Institute, Wrocław, Poland; 4Centrum Medyczne All-Med, Krakòw, Poland; 5Institute of Medical Sciences, Medical College of Rzeszow University, Rzeszow, Poland; 6Department of Research, Development and Innovation, FAES FARMA, Leioa, Bizkaia, SpainCorrespondence: Nieves Fernández Hernando, FAES FARMA, S.A, Av. Autonomía 10, Leioa, Bizkaia, 48940, Spain, Tel +34 94 481 83 00, Email nfernandez@faes.esPurpose: The objective of this study was to assess the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in patients with allergic conjunctivitis (AC).Patients and Methods: Multi-center, international, randomized, double blind, placebo-controlled, parallel-group, phase III study of adult patients with seasonal or perennial AC. The study was conducted in 26 centers of 5 European countries. Duration of daily treatment with bilastine 0.6% ophthalmic solution or placebo was 8 weeks. Safety was evaluated by analyzing incidence of ocular treatment-emergent adverse events (TEAEs); additionally, and as secondary parameters, ocular tolerability was assessed, in addition efficacy was also assessed by the average daily total eye symptoms score (TESS).Results: A total of 333 randomized patients with AC were included (bilastine, N=218; placebo, N=115). Mean (SD) age of the patients was 39.9 (13.7) and were 63.7% female. Overall, the percentage of ocular related TEAEs was low, and the percentage of patients with ocular related TEAEs was lower in the bilastine ophthalmic solution group (2.8%) than in the placebo group (4.3%). No severe TEAEs were reported. The ocular symptoms and TESS improved during the trial in both treatment groups. Statistically significant treatment differences were observed at Week 8 for the TESS and all individual ocular symptoms, being significantly better in the bilastine ophthalmic solution group than in placebo group.Conclusion: Bilastine 0.6% ophthalmic solution revealed no safety concerns in patients with AC after 8 weeks of once-daily administration. Bilastine was effective in reducing ocular symptoms associated with AC in response to both seasonal and perennial allergens.Keywords: H1-antihistamine, bilastine, safety, allergic conjunctivitis, ocular allergy, ophthalmic solution