Bromday

(Bromfenac)

ApprovedSmall molecule

Bromfenac is an anti-inflammatory eye drop used to reduce pain and swelling in the eye after cataract surgery or other eye procedures.[2] Bromday is currently approved and in use across 8 indications[4].[1]

Bromday is one of 151 small molecule programs targeting Myopia. It is currently in Approved.

Indications

Total Trials

Active Trials

150

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MyopiaActive, not recruiting

Cystoid Macular EdemaActive, not recruiting

Allergic ConjunctivitisActive, not recruiting

Dry Eye SyndromeApproved

Eye InflammationActive, not recruiting

PresbyopiaApproved

CataractApproved

Diabetic Macular EdemaActive, not recruiting

MyopiaPreclinical

Active, not recruiting

Cystoid Macular EdemaPhase 2

Active, not recruiting

Allergic ConjunctivitisPhase 3

Active, not recruiting

Dry Eye SyndromeApproved

Approved

Eye InflammationApproved

Active, not recruiting

PresbyopiaApproved

Approved

CataractApproved

Approved

Diabetic Macular EdemaPhase 1

Active, not recruiting

Competition

Competitive Landscape

219 competitors in Cataract

#DrugCompanyPhaseTrials

Bromday

BBausch Health Americas, Inc.

Approved

10 2

Pred Forte

Novartis

Phase 3

6 3

Lotemax

BBausch & Lomb Incorporated

Phase 3

7 4

Toradol

JJavelin Pharmaceuticals

Phase 3

4 5

Clobetasol Propionate

Bayer

Phase 3

3 6

ISV-305

Sun Pharmaceutical Industries Limited

Phase 3

2 7

Midalozam

Idorsia Pharmaceuticals Ltd.

Phase 3

2 8

Zolymbus

AbbVie

Preclinical

—9

Neurontin

VViatris Specialty LLC

Preclinical

3 10

Ceftin

PPhiladelphia Eye Associates

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Cataract10 trials

Effectiveness of Periocular Drug Injection in CATaract Surgery

Terminated·LLuigi Rondas·Phase 3·NCT05158699·628 enrolled

Safety and Efficacy Study of Topical Bromfenac Versus Placebo to Treat Ocular Inflammation After Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00198445·527 enrolled

Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

Completed·BBp Consulting, Inc·Phase 4·NCT00758199·49 enrolled

Show 7 more trials

Study Title: Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

Completed·SSilverstein Eye Centers·Phase 4·NCT03886779·57 enrolled

PRevention of Macular EDema After Cataract Surgery

Completed·MMaastricht University Medical Center·Phase 3·NCT01774474·1,127 enrolled

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00704418·156 enrolled

Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT01367249·440 enrolled

Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00853970·299 enrolled

Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00333918·522 enrolled

Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00703781·126 enrolled

Ketorolac2 trials

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Completed·FFrank A. Bucci, Jr., M.D.·Phase 4·NCT01021761·126 enrolled

Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Completed·FFlorida Eye Microsurgical Institute·Phase 4·NCT00520260·42 enrolled

Cystoid Macular Edema2 trials

Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

Completed·BBp Consulting, Inc·Phase 4·NCT00595543·166 enrolled

Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema.

Withdrawn·JJohns Hopkins University·Phase 2·NCT00438243

Surgery1 trial

Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery

Completed·IInas Abd·Phase 4·NCT06785090·87 enrolled

Intravitreal Injections1 trial

Control of Pain in Intravitreal Injections Using Topical NSAIDs

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT04343222·46 enrolled

6 more indications

Pain1 trial

Bromday Versus Nevanac Eye Drops to Control Pain Following Photorefractive Keratectomy

Completed·VVirdi Eye Clinic··NCT01475877·20 enrolled

Outcome1 trial

Clinical Outcomes of Bromday (Bromfenac Ophthalmic Solution) 0.09% QD vs. Nevanac (Nepafenac Ophthalmic Suspension) 0.1%

Completed·TToyos Clinic·Phase 4·NCT01310127·23 enrolled

Allergic Conjunctivitis1 trial

Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic Conjunctivitis

Completed·BBausch & Lomb Incorporated·Phase 3·NCT00423007·90 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Bromfenac Ophthalmic Solution

Completed·BBausch & Lomb Incorporated·Phase 2·NCT00585975·568 enrolled

Diabetic Macular Edema1 trial

Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser

Unknown status·OOphthalmic Consultants of Boston·Phase 1·NCT00491166·10 enrolled

Unspecified1 trial

Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

Completed·LLaboratorios Sophia S.A de C.V.·Phase 1·NCT01535443·35 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 16, 2010

BROMDAY

NDA NDA021664

Apr 5, 2013

PROLENSA

NDA NDA203168

Apr 8, 2016

BROMSITE

NDA NDA206911

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Bromfenac. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Bromday drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bromfenac compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bromfenac. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206911). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Bromday. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Patent Landscape[6]

Patent Cliff

Mar 5, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE50218Mar 5, 2029

10085958Nov 19, 2032

9517220Nov 11, 2033

Bromday

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Cataract10 trials

Ketorolac2 trials

Cystoid Macular Edema2 trials

Surgery1 trial

Intravitreal Injections1 trial

Pain1 trial

Outcome1 trial

Allergic Conjunctivitis1 trial

Efficacy and Safety1 trial

Diabetic Macular Edema1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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