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

Abstract

Purpose

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

Data Sharing Statement

Data available from the corresponding author upon reasonable request due to privacy/ethical reasons.

Ethics Approval and Informed Consent

The protocol for this study was approved by Independent Ethics Committees prior to each center’s initiation (See Table S1). Written informed consent was received from all patients prior to enrolment into the trial, which was conducted in accordance with the Declaration of Helsinki and all local regulations.

Acknowledgments

Francisco López de Saro (Trialance SCCL) provided medical writing assistance with the preparation of this manuscript.

Disclosure

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.

Additional information

Funding

This study was funded by FAES Farma SA (Leioa, Spain). This work was partially supported by the Basque Country Government (Economic Development and Infrastructures Department) through the HAZITEK program (grant number: ZE-2019/00004, 2019).