TheraRadar
Data updated: May 26, 2026

BEPREVE (bepotastine besilate)

Trial Activity: Declining
Ophthalmology Approved 2009-09-08

BEPREVE is an ophthalmic solution that treats the itching associated with allergic conjunctivitis. It helps patients who experience eye irritation and other symptoms caused by allergic reactions. This medication is used to provide relief from the specific discomfort and signs that accompany this ocular condition.

Source: FDA Label • BAUSCH AND LOMB INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How BEPREVE Works

This medication works by directly blocking H1-receptors and preventing mast cells from releasing histamine. By targeting these specific receptors and inhibiting histamine release, the drug stops the chemical triggers that cause allergic symptoms in the eye.

Source: FDA Label

Development Insights

Tanabe Pharma Corporation conducting 3 trials (50%)
9 indications explored (Moderate)
→ perennial allergic rhinitis (2 trials)
→ dermatitis (1 trials)
→ atopic (1 trials)
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-09-08
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

BAUSCH AND LOMB INC
Active Ingredient: BEPOTASTINE BESILATE

BEPREVE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2009 to 2018
Feb 2018 SUPPL
Label · Labeling
FDA Letter Label
Feb 2016 SUPPL
Mfg · Manufacturing (CMC)
Jun 2012 SUPPL
Label · Labeling
FDA Letter Label

What BEPREVE Treats

1 indications

BEPREVE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Allergic Conjunctivitis
Source: FDA Label

BEPREVE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

9

Same indication, different mechanism — what else might this patient receive?

LOTEPREDNOL ETABONATE AND TOBRAMYCIN
ALEMBIC
2025 9 indic.
LOTEPREDNOL ETABONATE
PADAGIS US
2019 9 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BEPREVE

3 of 15

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACULAR
KETOROLAC TROMETHAMINE
1 shared
AbbVie
Shared indications:
Allergic Conjunctivitis
ALREX
LOTEPREDNOL ETABONATE
1 shared
BAUSCH AND LOMB
Shared indications:
Allergic Conjunctivitis
BEPOTASTINE BESILATE
BEPOTASTINE BESILATE
1 shared
SOMERSET THERAPS LLC
Shared indications:
Allergic Conjunctivitis
View all 15 similar drugs Pro
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Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT01861522 results posted TAU-284-20 Ph 3 completed The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
NCT01840605 results posted TAU-284-19 Ph 3 completed A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
NCT01900054 results posted TAU-284-18 Ph 3 completed A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
NCT04693429 PRO-172 results posted SOPH172-0919/I Ph 1 completed Clinical Study for the Evaluation of Safety and Tolerability of PRO-172 Ophthalmic Solution+
NCT01753739 results posted 823 Ph 2 completed Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
NCT01128556 MAC-01-10 Ph 4 completed The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BEPREVE FDA Label Details

Indications & Usage

FDA Label (PDF)

BEPREVE is indicated for the treatment of Allergic Conjunctivitis.

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Data Sources

FDA Approval: NDA022288 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment