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Label indication BEPREVE ® (bepotastine besilate ophthalmic solution) 1.5% is a histamine H 1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis. BEPREVE is a histamine H1 receptor antagonist indicated for the treatment of itching associated with allergic conjunctivitis. ( 1 ) FDA label
Also known as bepotastine besilate ophthalmic solution, Bepotastine besilate formulation, Bepotastine Besilate Ophthalmic Solution 1.0%, Bepotastine Besilate 1.0%
bepotastine besilate · 3 trials · 2 indications
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 and a maximum score of 12 units, with higher score corresponding to increased severity of nasal allergy symptoms. The morning and evening scores were averaged.
Responses to questions relating to symptoms and daily activities in the RQLQ were provided for 28 questions encompassing the 7 major domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional state. Each response to an RQLQ question was provided on a scale of 0-6 units, where 0 = not troubled/none of the time and 6 = extremely troubled/all of the time. The minimum total score was 0 units and the maximum total score was 42 units, with higher score indicating decreased quality of life due to rhinoconjunctivitis.
| Arm | Type | Description |
|---|---|---|
| Bepotastine besilate Concentration 1 | EXPERIMENTAL | Bepotastine besilate nasal spray, BID for 14 days. |
| Placebo | ACTIVE_COMPARATOR | Placebo nasal spray BID for 14 days |
| Bepotastine besilate Concentration 2 | EXPERIMENTAL | Bepotastine besilate nasal spray, BID for 14 days. |
| Bepotastine besilate Concentration 3 | EXPERIMENTAL | Bepotastine besilate nasal spray, BID for 14 days. |
| Bepotastine besilate Concentration 4 | EXPERIMENTAL | Bepotastine besilate nasal spray, BID for 14 days. |
| Bepotastine besilate formulation | EXPERIMENTAL | Nasal Spray |
| Fluticasone propionate | EXPERIMENTAL | Nasal Spray |
| Bepotastine besilate-fluticasone propionate | EXPERIMENTAL | Nasal Spray |
| Placebo Comparator | PLACEBO_COMPARATOR | Nasal Spray |
| Bepotastine Besilate Ophthalmic Solution | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Bepotastine besilate | DRUG | Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| Placebo | DRUG | Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| Bepotastine besilate formulation | DRUG | Nasal Spray |
| Fluticasone propionate | DRUG | Nasal Spray |
| Bepotastine besilate-fluticasone propionate | DRUG | Nasal Spray |
| Placebo Comparator | DRUG | Nasal Spray |
| bepotastine besilate ophthalmic solution | DRUG | sterile ophthalmic solution |
| placebo comparator ophthalmic solution | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * The subject is a male or female 12 years of age or older. * Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1. * Have demonstrated sensitivity to Mountain Cedar pollen through a st...
Bepotastine besilate is a small molecule drug developed by Bausch + Lomb Corporation (ticker BLCO). It is being studied in Phase 2 clinical trials for allergic conjunctivitis and seasonal allergic rhinitis. It is an HRH1 antagonist.
Bepotastine besilate is being developed for the treatment of allergic conjunctivitis and seasonal allergic rhinitis. It is currently in Phase 2 clinical development.
Bepotastine besilate targets HRH1, the histamine H1 receptor. It acts as an antagonist at this receptor.
Bepotastine besilate is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO.
Bepotastine besilate is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for the studied indications.
Bepotastine besilate has been studied in completed Phase 2 trials: NCT01753739 and NCT01578278 in seasonal allergic rhinitis, and NCT01174823 in allergic conjunctivitis. All were randomized, double-blind, and placebo-controlled.
Yes, bepotastine besilate is also known as bepotastine besilate ophthalmic solution, bepotastine besilate formulation, bepotastine besilate ophthalmic solution 1.0%, and bepotastine besilate 1.0%. These names refer to the same active ingredient.