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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 Bepreve (bepotastine besilate ophthalmic solution) 1.5%, Bepreve 1.5%
Bepreve · 3 trials · 2 indications
A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
Ocular Itching score: 0=None; 0.5=Intermittent tickle sensation possibly localized in the corner of the eye; 1.0=Intermittent tickle sensation involving more than the corner of the eye; 1.5=Intermittent all-over tickling sensation; 2.0=Mild continuous itch (can be localized) without desire to rub; 2.5=Moderate, diffuse continuous itch with desire to rub; 3.0=Severe itch with desire to rub; 3.5=Severe itch improved with minimal rubbing; 4.0=Incapacitating itch with irresistible urge to rub
Conjunctival Redness score: 0=None; 1.0=Mild-Slightly dilated blood vessels; color of vessels typically pink; 2.0=Moderate-More apparent dilation of blood vessels; vessel color more intense (redder); 3.0=Severe-Numerous, obvious dilated blood vessels; absence of chemosis color is deep red, presence of chemosis may be less red or pink; 4.0=Extremely severe-Large, numerous dilated blood vessels characterized by severe deep red color regardless of chemosis grade
| Arm | Type | Description |
|---|---|---|
| Bepreve | EXPERIMENTAL | bepotastine besilate ophthalmic solution 1.5% |
| Placebo | PLACEBO_COMPARATOR | vehicle |
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | EXPERIMENTAL | - |
| Bepotastine Besilate Ophthalmic Solution 1.0% | EXPERIMENTAL | - |
| Bepotastine Besilate | EXPERIMENTAL | sterile ophthalmic solution 1.0% |
| Name | Type | Description |
|---|---|---|
| Bepreve | DRUG | One drop, both eyes, twice a day |
| Placebo | DRUG | One drop, both eyes, twice a day |
| Bepreve (bepotastine besilate ophthalmic solution) 1.5% | DRUG | sterile ophthalmic solution |
| placebo comparator | DRUG | sterile ophthalmic solution |
| Bepotastine Besilate Ophthalmic Solution 1.0% | DRUG | sterile ophthalmic solution |
| Bepotastine Besilate | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * Subjects must be at least 3 years of age, and have ocular health within normal limits Exclusion Criteria: * No active ocular disease
Bepreve is an ophthalmic solution indicated for allergic conjunctivitis, a condition marked by itchy, red, and watery eyes caused by allergic reactions. It is formulated as bepotastine besilate ophthalmic solution 1.5% and is applied directly to the eye. The clinical program for Bepreve enrolled 1,098 participants across three completed trials in allergic conjunctivitis.
Bepreve is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is responsible for the clinical development and regulatory strategy for bepotastine besilate ophthalmic solution 1.5% in allergic conjunctivitis.
Bepreve has been studied in Phase 3 clinical development for allergic conjunctivitis. The program includes three completed trials, with two Phase 3 studies and one Phase 2 study. All three trials are completed, and no active trials are currently listed for this asset.
Bepreve has been evaluated in three completed clinical trials: NCT00586664, a Phase 3 efficacy and safety study in allergic conjunctivitis; NCT00586625, a Phase 3 safety study in normal volunteers; and NCT00424398, a Phase 2 study of onset and duration of action in acute allergic conjunctivitis. Together these trials enrolled 1,098 participants.
Yes, Bepreve is the brand name for bepotastine besilate ophthalmic solution 1.5%. The two names refer to the same product, a small molecule formulation developed by Bausch + Lomb for allergic conjunctivitis. Searches for either name lead to the same clinical program and development history.