Integrated phase III trials of bepotastine besilate ophthalmic solution 1.5% for ocular itching associated with allergic conjunctivitis
Eye Care Associates of Greater Cincinnati, Inc., Mason, Ohio, USA.Allergy and Asthma Proceedings (Impact Factor: 3.06). 05/2012; 33(3):265-74. DOI: 10.2500/aap.2012.33.3570
Allergic conjunctivitis is a clinical reaction to environmental allergens and is manifested by ocular itching caused by IgE-induced mast cell degranulation. Bepotastine besilate is a selective H(1)-antagonist with mast cell stabilizing properties. This report examines the reduction of ocular itching integrated from two conjunctival allergen challenge (CAC) clinical trials comparing bepotastine besilate ophthalmic solution (BBOS) 1.5% to placebo in subjects with a history of allergic conjunctivitis. Two phase III, double-masked, placebo-controlled, parallel-group, CAC clinical trials evaluated BBOS 1.5% versus placebo to reduce ocular itching. Eligible subjects were randomly assigned 1:1 to either BBOS 1.5% (n = 78) or placebo (n = 79). Ocular itching was graded by subjects using a standardized scale (0–4 U). Adverse events and ophthalmic clinical findings were recorded for safety. BBOS 1.5% was superior to placebo for reducing CAC-induced ocular itching (p < 0.0001) as early as 3 minutes post-CAC and for at least 8 hours after dosing. Post hoc analyses examining several populations also showed a significant improvement (p < 0.0001) for subjects with more severe itching response at screening and for the proportion of subjects with complete or nearly complete resolution of CAC-induced itching, both outcomes supporting the clinical benefit of BBOS 1.5%. Adverse events were generally transient and mild. BBOS 1.5% is safe and effective in the treatment of ocular itching associated with allergic conjunctivitis within 3 minutes of a CAC and with a sustained duration of action of at least 8 hours. (ClinicalTrials.gov numbers: NCT00424398 and NCT00586664).
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ABSTRACT: The focus of this review is to provide a logical paradigm for the diagnosis and treatment of ocular allergies, with a focus on seasonal allergic conjunctivitis (SAC) and perennial allergic conjunctivitis (PAC). Several classes of topical medications are currently available for the management of ocular allergies, including: lubricating agents, vasoconstrictors, antihistamines, mast cell stabilizers, and topical corticosteroids. SAC and PAC make up the vast majority of ocular allergy cases. A proactive approach to these diseases, anticipating the regional spring and fall allergen spikes, is needed for optimally managing these disorders. A multifaceted treatment regimen comprising patient education, lifestyle modification, and topical medications (such as antihistamines and/or mast cell stabilizers and corticosteroids) may be required in order to manage ocular allergies effectively. The appropriate treatment paradigm is based on the severity of the patients' signs and symptoms. For moderate-to-severe cases, especially chronic vernal keratoconjunctivitis, atopic keratoconjunctivitis, and giant papillary conjunctivitis, comanagement with an ophthalmologist is recommended.Current Opinion in Allergy and Clinical Immunology 08/2013; 13(5). DOI:10.1097/ACI.0b013e328364ec3a · 3.57 Impact Factor
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ABSTRACT: Introduction: Bepotastine besilate 1.5% is a newly approved second-generation topical antihistamine indicated for the pruritus associated with allergic conjunctivitis. In Japan, the oral formulation is approved to manage pruritus associated with allergic rhinitis and urticaria. Areas covered: Bepotastine is a piperidine derivative that antagonizes H1 receptors with high selectivity. It has been labeled a dual-acting or multiple-acting antiallergic medication, because it inhibits histamine at H1 receptors and stabilizes mast cells to prevent histamine release. Bepotastine may also have other immunoactive properties, such as inhibition of eosinophil migration, interleukin-5 (IL-5), leukotrienes (e.g., LTB4) and platelet-activating factor (PAF). Human clinical trials demonstrate the efficacy and safety of systemic and ophthalmic bepotastine for pruritus relief, limited penetration across the blood-brain-barrier and kinetics suitable for twice-daily administration. Expert opinion: Bepotastine besilate 1.5% ophthalmic solution is a safe and effective treatment option for allergic conjunctivitis associated pruritus. Side-effect profile is similar to other ocular antihistamine agents. Additional comparative-effectiveness studies would further advance its clinical use. Oral bepotastine is a safe and effective treatment option approved in Japan for allergic rhinitis, urticaria and pruritus associated with skin diseases.Expert Opinion on Pharmacotherapy 11/2013; 14(18). DOI:10.1517/14656566.2013.849242 · 3.53 Impact Factor
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ABSTRACT: Introduction: Allergic conjunctivitis (AC) is a very common disease, especially in association with allergic rhinitis but may also occur in isolated presentation. The treatment of AC has long been based on antihistamines, cromones and topical corticosteroids, but none of these drugs completely abolishes the clinical expression of AC. Areas covered: The development of new drugs for AC is analyzed highlighting the recent insights into the pathophysiological mechanisms of the disease. The major aim of development of drugs for AC is to have agents able to prevent the inflammatory effects of the interaction between the allergen and the specific IgE antibodies on mast cell surface. This may be obtained by blocking the effects of histamine (the main mediator of early allergic response) by H1-receptor antagonists, inhibiting the release of soluble factors able to recruit inflammatory cells (that sustain prolonged inflammation) by mast-cell stabilizers, inhibiting the effects of single mediators, inducing tolerance to the allergen by specific immunotherapy or even acting on factors related to activation and differentiation of T lymphocytes such as the toll-like receptors. Expert opinion: AC is an underestimated disease for which there is a search of more effective treatments. The availability of the drugs under current evaluation will allow more refined therapeutic strategies to apply according to the characteristics and the clinical severity of AC.Expert Opinion on Emerging Drugs 03/2014; 19(2). DOI:10.1517/14728214.2014.902443 · 3.06 Impact Factor
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