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bepotastine besilate ophthalmic solution
bepotastine besilate ophthalmic solution is a Small molecule drug developed by Bausch & Lomb Incorporated. It is currently FDA-approved for Allergic conjunctivitis.
Bepotastine blocks H1 receptors and inhibits histamine release from mast cells.
Bepotastine besilate ophthalmic solution, marketed by Bausch & Lomb, is an approved treatment for allergic conjunctivitis. Its dual mechanism of action, blocking H1 receptors and inhibiting histamine release from mast cells, provides a strong therapeutic profile. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | bepotastine besilate ophthalmic solution |
|---|---|
| Sponsor | Bausch & Lomb Incorporated |
| Target | H1-receptor, mast cells |
| Modality | Small molecule |
| Phase | FDA-approved |
Mechanism of action
Bepotastine works by directly blocking H1 receptors, which prevents the effects of histamine. Additionally, it stops mast cells from releasing histamine, reducing allergic symptoms.
Approved indications
- Allergic conjunctivitis
Common side effects
- mild taste following instillation
Key clinical trials
- Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+ (PHASE1)
- Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment (PHASE4)
- Safety and Efficacy of Bepotastine Besilate Ophthalmic Solution in Seasonal Allergic Conjunctivitis Patients (PHASE2)
- The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer (PHASE4)
- Comparing Patient Satisfaction With Pataday or Bepreve (NA)
- Evaluation of the Onset and Duration of Action of Bepotastine Besilate Ophthalmic Solution in Acute Allergic Conjunctivitis (PHASE2, PHASE3)
- Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers (PHASE3)
- Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- bepotastine besilate ophthalmic solution CI brief — competitive landscape report
- bepotastine besilate ophthalmic solution updates RSS · CI watch RSS
- Bausch & Lomb Incorporated portfolio CI