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

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). 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). 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. 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.

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© 2023 Kuna et al.

Déclaration de conflit d'intérêts

PA, GH and NFH are employees of FAES FARMA. In addition, GH NFH have a patent EP3740191B1 issued to FAES FARMA. MJ reports personal fees from FAES PHARMA, during the conduct of the study; personal fees from Allergopharma, ALK, Stallergenes, Hal, Allergy Therapeutics, Leti, GSK, Novartis, Genentech, TEVA, TAKEDA, Chiesi, Shire, Janssen, Celltrion, Sanofi, Regeneron, outside the submitted work. PK reports personal fees from Adamed, AstraZeneca, Boehringer Ingelheim, Berlin Chemie Menarini, Celon Pharma, FAES, Novartis, Glenmark, Polpharma, GSK, Sandoz, and Teva, outside the submitted work. GP is affiliated with Centrum Medyczne All-Med. The authors report no other conflicts of interest in this work.