Abstract
Purpose :
Allergic conjunctivitis (AC) is a common ocular disease with a growing incidence rate. Novel topical therapies add to a physician’s armamentarium. The aim of this work was to evaluate the efficacy of three concentrations of Bilastine Eye Drops, as a multi-dose, preservative-free formulation, for the treatment of the signs and symptoms of AC.
Methods :
This was a single-center, double-masked, randomized, vehicle-controlled, phase 2, dose ranging study conducted to assess the efficacy of bilastine ophthalmic formulation for treatment of the signs and symptoms of AC. The Ora-CAC® Allergen Challenge Model was used to assess acute allergic responses. Subjects must have had a history of ocular allergies and a positive skin test reaction to a seasonal or perennial allergen. On Day 1, 121 subjects with AC were randomized to receive Bilastine 0.2% N=30, 0.4% N=30, 0.6% N=31 or vehicle N=30. Two duration-of-action (16 hours post drop on Day 1 and 8 hours post drop on Day 15) and one onset-of-action (15 minutes post drop on Day 22) visits were conducted. The primary efficacy analyses (ocular itching) were conducted using analysis of covariance (ANCOVA) models. Least square (LS) means were estimated for each treatment and for the difference between each active treatment and vehicle at each visit and time point.
Results :
All three concentrations of bilastine showed efficacy controlling ocular itching at 15 minutes and 8 hours post treatment. Bilastine 0.6% was also effective at 16 hours post treatment, compared to vehicle. Mean treatment differences at all time points were ≥ 1 unit for bilastine 0.6% (P<0.0001). Statistically significant (P<0.05) treatment effects were observed for bilastine 0.6% compared to vehicle in the secondary endpoint of conjunctival redness at all 3 visits. For the exploratory endpoints of tearing, eyelid swelling and nasal symptoms, treatment differences were statistically significant (P<0.05) for bilastine 0.6% compared to vehicle at all 3 treatment visits. All concentrations showed a good overall safety profile with comfort scores comparable to vehicle.
Conclusions :
Bilastine ophthalmic formulation is an effective and safe treatment for AC, with the 0.6% concentration exhibiting the most efficacy in reducing signs and symptoms lasting at least 16 hours post treatment, making it suitable for once-daily administration. Bilastine was well tolerated.
This is a 2021 ARVO Annual Meeting abstract.