Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bepotastine besilate · 4 trials · 2 indications
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
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 |
|---|---|---|
| Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5% | EXPERIMENTAL | - |
| Bepotastine Besilate Ophthalmic Solution 1.0% | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Bepotastine besilate Concentration 1 | EXPERIMENTAL | Bepotastine besilate 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 |
|---|---|---|
| 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 | 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 |
| bepotastine besilate ophthalmic solution | DRUG | sterile ophthalmic solution |
| placebo comparator ophthalmic solution | DRUG | sterile ophthalmic solution |
Inclusion Criteria: * Subjects must be at least 10 years of age Exclusion Criteria: * No active ocular disease
Bepotastine besilate is an investigational small molecule being developed for seasonal allergic rhinitis and allergic conjunctivitis. It is being studied in ophthalmic solution and nasal spray formulations. The drug is currently in Phase 2 clinical development and is not approved by the FDA.
Bepotastine besilate is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials for the drug in the United States for allergic conjunctivitis and seasonal allergic rhinitis.
Bepotastine besilate is in Phase 2 clinical development. While some completed trials were Phase 3, the overall development program is currently at Phase 2. The drug is investigational and has not received FDA approval for any indication.
Bepotastine besilate has completed four clinical trials. NCT00586664 and NCT01174823 studied the ophthalmic solution in allergic conjunctivitis. NCT01578278 and NCT01753739 evaluated nasal sprays in seasonal allergic rhinitis. All trials were completed in the United States with a total enrollment of 1,223 participants.
Bepotastine besilate is a salt form of bepotastine, an antihistamine. The besilate salt is used in the ophthalmic and nasal formulations being studied. The drug is being developed by Bausch + Lomb for allergic conditions affecting the eyes and nose.