Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bepreve · 2 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 |
| 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 |
| 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 used for allergic conjunctivitis, a condition in which the conjunctiva of the eye becomes inflamed due to an allergic reaction. It is an ophthalmic solution being developed by Bausch + Lomb Corporation for the treatment of this eye condition.
Bepreve is a small molecule that acts as an antihistamine, targeting histamine receptors to reduce the allergic response in the eye. It is designed to relieve symptoms of allergic conjunctivitis by blocking the effects of histamine, a chemical released during allergic reactions.
Bausch + Lomb Corporation, traded under the ticker BLCO, is developing Bepreve. The company is focused on ophthalmology and is advancing this small molecule as a treatment for allergic conjunctivitis.
Bepreve is in Phase 3 clinical development. It has completed a Phase 3 safety study with 861 participants, and it is not yet FDA approved. The drug remains investigational and is still undergoing clinical trials to evaluate its safety and efficacy.
Bepreve has been studied in two completed clinical trials. NCT00424398, a Phase 2 study, evaluated the onset and duration of action in acute allergic conjunctivitis with 107 participants. NCT00586625, a Phase 3 safety study, enrolled 861 healthy volunteers to assess the drug's safety.
Yes, Bepreve is the brand name for bepotastine besilate ophthalmic solution. The clinical trials for Bepreve, including NCT00424398 and NCT00586625, refer to the drug as bepotastine besilate, confirming that these names describe the same medication.