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Efficacy of once-daily ophthalmic bilastine for the treatment of allergic conjunctivitis: a dose-finding study

Gomes PJ1, Ciolino JB2, Arranz P3, Hernández G3, Fernández N3

1Ora, Inc., Andover, MA, USA
2Department of Ophthalmology, Harvard Medical School, Boston, MA, USA
3Department of Research, Development and Innovation, FAES FARMA, Bizkaia, Spain

J Investig Allergol Clin Immunol 2023; Vol. 33(4)
doi: 10.18176/jiaci.0800

Background and objectives: Bilastine is a non-sedating second-generation antihistamine for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. This trial aimed to evaluate the optimal dose, efficacy, and safety of a newly developed once-daily preservative-free ophthalmic formulation of bilastine for allergic conjunctivitis.
Methods: This phase 2, single-center, double-masked, randomized study evaluated the efficacy of 3 doses of a bilastine ophthalmic formulation (0.2%, 0.4%, and 0.6%) compared to vehicle for the treatment of allergic conjunctivitis. The primary efficacy endpoint was ocular itching reduction. The Ora-CAC® Conjunctival Allergen Challenge model was used to assess ocular and nasal symptoms at the onset of action (15 minutes), 8- and 16-hours post-treatment. Tolerance and safety were also evaluated.
Results: A total of 121 adults with seasonal and/or perennial ocular allergy were randomized. Bilastine ophthalmic formulation 0.2%, 0.4% and 0.6% were significantly superior (p>0.001) to vehicle for the treatment of ocular itching at 3, 5 and 7 minutes post-challenge at onset of action (15 minutes) and 8 hours post-treatment. Bilastine 0.6% was also effective at 16 hours post-treatment. Treatment differences for bilastine 0.6% were statistically significant (p<0.001) compared to vehicle at all timepoints for tearing, eyelid swelling, and nasal symptoms. No relevant adverse events were observed.
Conclusions: All the tested ophthalmic bilastine doses were efficacious in rapidly reducing ocular itching. The 0.6% formulation was effective up to 16 hours post-treatment, making it suitable for once-daily administration. The new formulation was safe and well tolerated.

Key words: Allergic Conjunctivitis, Antihistamine, Ocular Itching, Bilastine, Once-Daily, Preservative-Free