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 efficacy of a new once-daily Bilastine 0.6% multi-dose preservative-free ophthalmic solution (BOS) for the treatment of the signs and symptoms of AC was evaluated. Non-inferiority testing was conducted between BOS and a marketed multi-dose formulation of ketotifen 0.025% (KOS).
Methods :
This was a multi-center, double-masked, randomized, vehicle and active controlled, phase 3 study conducted to assess the efficacy for treatment of the signs and symptoms of AC, safety, and tolerability of BOS. The Ora-CAC® Allergen Challenge Model was used to assess acute ocular and nasal 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, 228 adult subjects with AC were randomized to receive BOS N=91, KOS N=90, or vehicle N=47. A duration-of-action (16 hours post drop on Day 1) and an onset-of-action (15 minutes post drop on Day 15) visit was conducted. The primary efficacy endpoint was ocular itching. Statistical testing included superiority comparisons of BOS vs. vehicle at onset and duration of action and non-inferiority of BOS to KOS at onset.
Results :
BOS showed efficacy reducing ocular itching at 15 minutes and 16 hours post treatment (P<0.001) while KOS showed efficacy at 15 minutes (P<0.001). BOS was non-inferior to KOS at onset. BOS demonstrated improvement over vehicle (P<0.05) for conjunctival/ciliary/episcleral redness, chemosis, eyelid swelling, tearing, rhinorrhea, ear/palate pruritus and nasal congestion at onset. BOS was safe and well tolerated. BOS was significantly more comfortable (P<0.05) than KOS immediately upon instillation and similar to vehicle.
Conclusions :
Bilastine 0.6% preservative free eye drops developed by Faes Farma is effective at reducing ocular itching up to 16 hours post-treatment. Bilastine was safe and well tolerated. This multi-dose preservative-free formulation can be used as a once-daily treatment for the signs and symptoms of AC.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.