Drugs / Bromfenac
Bromfenac
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cataract 50 with or without glaucoma 1 milestone | |||||
| Filed | US (FDA) | Brom Site | cataract 50 with or without glaucoma | — | “recently filed a New Drug Application (NDA) with the US FDA for Brom Site™ (0.075% bromfenac)” sunpharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Yellox | — | 2011-05-18 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | BROMDAY | — | 2006-01-27 – 2010-10-16 | fda.gov ↗ |
| Approved | US (FDA) | BROMDAY | — | 2005-03-24 | fda.gov ↗ |
Trials 37
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05006911 | Aug → Sep 2021 | presbyopia | Optall Vision | Unknown | No outcome recorded |
| Phase 1 | NCT01535443 | Sep → Oct 2011 | cataract | Laboratorios Sophia S.A de C.V. | Completed | No outcome recorded |
| Phase 1 | NCT00491166 | Jun 2007 → ? | diabetic macular edema | Ophthalmic Consultants of Boston | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01190878 | Aug 2010 → Jan 2011 | — | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 28 trials · 1 missed | ||||||
| Phase 2 | NCT05107921 | Nov 2021 → Oct 2024 | exudative vitreoretinopathy | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01478555 | Jan → Jul 2018 | dry eye syndrome | Sun Pharmaceutical Industries, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01657266 | Dec 2013 → Mar 2015 | cataract 50 with or without glaucoma | Laboratorios Sophia S.A de C.V. | Completed | Missed primary |
| Phase 2 | NCT01387464 | Jul → Aug 2011 | cataract | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00805233 | Dec 2008 → Sep 2010 | age-related macular degeneration | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT00758784 | Aug 2008 → Jan 2009 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 2 | NCT00438243 | May 2008 → Jul 2010 | cystoid macular edema | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00585975 | Oct 2007 → Jul 2008 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 312 trials · 2 met primary | ||||||
| Phase 3 | NCT03597867 | Apr → Jul 2018 | — | University of Trieste | Completed | No outcome recorded |
| Phase 3 | NCT02361645 | Mar → Nov 2014 | hyalitis | University of Brescia | Completed | No outcome recorded |
| Phase 3 | NCT01808547 | May → Nov 2013 | eye adnexa disorder | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01576952 | Jul 2012 → Jan 2013 | eye adnexa disorder | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01367249 | May → Jul 2011 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT01212471 | Sep 2010 → Aug 2011 | dry eye syndrome | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00853970 | Feb → Sep 2009 | — | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT00703781 | Jun → Nov 2008 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00704418 | Jun 2008 → Jan 2009 | cataract | Bausch & Lomb Incorporated | Completed | Met primary |
| Phase 3 | NCT00423007 | Nov 2006 → Aug 2007 | conjunctivitis | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00333918 | Jun 2006 → Mar 2007 | — | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 3 | NCT00198445 | May 2003 → Jan 2004 | cataract | Bausch & Lomb Incorporated | Completed | No outcome recorded |
| Phase 412 trials | ||||||
| Phase 4 | NCT06785090 | May 2023 → Jan 2024 | cataract, cystoid macular edema | Inas Abd | Completed | No outcome recorded |
| Phase 4 | NCT04940338 | May → Oct 2021 | cystoid macular edema | University Hospital Centre Zagreb | Completed | No outcome recorded |
| Phase 4 | NCT06130384 | Mar 2021 → Aug 2023 | — | Wills Eye | Completed | No outcome recorded |
| Phase 4 | NCT07696104 | Oct 2020 → May 2024 | cystoid macular edema | Pomeranian Medical University Szczecin | Completed | No outcome recorded |
| Phase 4 | NCT04343222 | Jun → Dec 2019 | — | University of Wisconsin, Madison | Completed | No outcome recorded |
| Phase 4 | NCT03317847 | Oct 2017 → Jun 2018 | eye adnexa disorder | Azienda USL Reggio Emilia - IRCCS | Completed | No outcome recorded |
| Phase 4 | NCT04022811 | Oct 2016 → Oct 2017 | pterygium | Zhongshan Ophthalmic Center, Sun Yat-sen University | Completed | No outcome recorded |
| Phase 4 | NCT02137161 | Nov 2013 → Oct 2014 | cataract, exfoliation syndrome | Azienda USL Reggio Emilia - IRCCS | Completed | No outcome recorded |
| Phase 4 | NCT01310127 | Nov 2010 → Apr 2011 | — | Toyos Clinic | Completed | No outcome recorded |
| Phase 4 | NCT00469690 | May 2007 → May 2008 | cataract | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00347503 | — | cataract | Innovative Medical | Completed | No outcome recorded |
| Phase 4 | NCT00377546 | — | — | Innovative Medical | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02681679 | Oct 2014 → Dec 2015 | cataract | Sun Yat-sen University | Completed | No outcome recorded |
| Comparator or background therapy22 trials | ||||||
| Phase 1 | NCT05001243 Comparator | Aug 2021 | presbyopia | Optall Vision | Unknown | No outcome recorded |
| Phase 3 | NCT05158699 Comparator | Oct 2021 → Aug 2024 | cataract, cystoid macular edema | Luigi Rondas | Terminated | No outcome recorded |
| Phase 3 | NCT02973880 Comparator | Oct 2017 → Dec 2018 | cataract | SIFI SpA | Completed | No outcome recorded |
| Phase 3 | NCT01774474 Comparator | Jul 2013 → Nov 2016 | cataract, cystoid macular edema, diabetes mellitus | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT07090044 Comparator | Aug 2021 → Dec 2022 | choroidal neovascularization, diabetic retinopathy, macular retinal edema, retinal vein occlusion | Retina Research Institute, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03751059 Comparator | Nov 2020 → Sep 2021 | glaucoma | Cindy Hutnik | Unknown | No outcome recorded |
| Phase 4 | NCT03578276 Comparator | Jun 2018 → Dec 2019 | cataract | Carolina Eyecare Physicians, LLC | Completed | No outcome recorded |
| Phase 4 | NCT03831984 Comparator | Mar → Nov 2018 | cataract | Hospital de La Luz | Unknown | No outcome recorded |
| Phase 4 | NCT05715385 Comparator | Nov 2014 → Oct 2015 | diabetic macular edema | Babasaheb Ambedkar Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03886779 Comparator | Oct 2013 → Feb 2017 | cataract | Silverstein Eye Centers | Completed | No outcome recorded |
| Phase 4 | NCT01023724 Comparator | Dec 2009 → Jan 2010 | anterior uveitis | Bucci Laser Vision Institute | Completed | No outcome recorded |
| Phase 4 | NCT01021761 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01001806 Comparator | Oct → Dec 2009 | cataract | Frank A. Bucci, Jr., M.D. | Completed | No outcome recorded |
| Phase 4 | NCT00828477 Comparator | Jan → Jun 2009 | — | Bp Consulting, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00758628 Comparator | Aug 2008 → May 2009 | diabetic macular edema | Bp Consulting, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00758199 Comparator | Jul 2008 → Jan 2010 | cataract | Bp Consulting, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00698724 Comparator | Jun 2008 → Jun 2009 | cataract | Bp Consulting, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00595543 Comparator | Jan 2008 → Mar 2009 | cystoid macular edema | Bp Consulting, Inc | Completed | No outcome recorded |
| Phase 4 | NCT00520260 Comparator | Aug 2007 → Aug 2008 | asthenopia, dry eye syndrome | Florida Eye Microsurgical Institute | Completed | No outcome recorded |
| Phase 4 | NCT00469781 Background | May 2007 → Sep 2008 | cystoid macular edema | Center For Excellence In Eye Care | Completed | No outcome recorded |
| — | NCT07178639 Comparator | Aug 2025 → Feb 2026 overdue | cataract, cystoid macular edema | Nemocnice Kolín | Recruiting | No outcome recorded |
| — | NCT01847638 Comparator | Apr 2013 → Jul 2016 | cataract, retinal edema | Melissa Toyos | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory 9th July, 2024, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Bromfenac Ophthalmic Solution, 0.07%. |
| 2024-01-09 | Lupin Limited | Regulatory Lupin Launches Bromfenac Ophthalmic Solution, 0.07% in the United States lupin.com ↗
Mumbai, Baltimore, January 09, 2024: Global pharma major Lupin Limited (Lupin) today announced the launch of Bromfenac Ophthalmic Solution, 0.07%, after having received an approval from the United States Food and Drug Administration (U.S. FDA). |
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-11-23 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Bromfenac Ophthalmic Solution, 0.07% lupin.com ↗ |
| 2023-08-16 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for Bromfenac Ophthalmic Solution, 0.09% lupin.com ↗ |
| 2019-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 24th June, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bromfenac Ophthalmic Solution 0.09%. |
| 2018-01-03 | Perrigo Company | Regulatory Perrigo Announces Tentative FDA Approval For The Generic Version Of Prolensa® Ophthalmic Solution 0.07% perrigo.com ↗
Perrigo Company plc (NYSE; TASE: PRGO) today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Prolensa ® (bromfenac ophthalmic solution) 0.07%. |
| 2016-04-09 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Receives USFDA Approval For BromSite™ sunpharma.com ↗
Sun Pharma Receives USFDA Approval For BromSite™ |
All press releases naming this drug 8 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-07-01 | Alembic Pharmaceuticals Ltd. | 9th July, 2024, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2024-01-09 | Lupin Limited | Lupin Launches Bromfenac Ophthalmic Solution, 0.07% in the United States lupin.com ↗ |
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-11-23 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Bromfenac Ophthalmic Solution, 0.07% lupin.com ↗ |
| 2023-08-16 | Lupin Limited | Lupin Receives Approval from U.S. FDA for Bromfenac Ophthalmic Solution, 0.09% lupin.com ↗ |
| 2019-06-01 | Alembic Pharmaceuticals Ltd. | 24th June, 2019, Vadodara, India alembicpharmaceuticals.com ↗ |
| 2018-01-03 | Perrigo Company | Perrigo Announces Tentative FDA Approval For The Generic Version Of Prolensa® Ophthalmic Solution 0.07% perrigo.com ↗ |
| 2016-04-09 | Sun Pharmaceutical Industries, Inc. | Sun Pharma Receives USFDA Approval For BromSite™ sunpharma.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 60 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bromfenac | “To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on...” NCT00698724 ↗56“Bromfenac is a potent inhibitor of the COX-2 enzyme and a highly lipophilic molecule that rapidly penetrates to produce early and sustained drug levels in all ocular tissues.” NCT02973880 ↗ “Bromfenac is a well-known topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) that is commercialized in the USA and other regions of the world.” PMID 28819932 ↗ Aug 2017 “Bromfenac 0.09% (0.9mg/mL) Ophthalmic solution Pre-medication: 1 drop each 15 minutes during 1 hour before surgery in the affected eye” NCT01657266 ↗ “standard topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and Prednisolone acetate 1%.” NCT03578276 ↗ “Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery” NCT03597867 ↗ “ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution)” NCT01478555 ↗ “0.075% bromfenac in DuraSite vehicle dosed BID” NCT01576952 ↗ “0.075% bromfenac in DuraSite dosed BID” NCT01808547 ↗ “0.075% bromfenac in DuraSite dosed QD” NCT01387464 ↗ “Bromfenac BID 3 months” NCT00758628 ↗ |
| Known as | Bromday | “Bromfenac Ophthalmic Solution Once Daily (Bromday) Study Group” PMID 21751945 ↗ Jul 2011 |
| Known as | Bromday (bromfenac ophthalmic solution) 0.9% | “Bromday (bromfenac ophthalmic solution) 0.9%” NCT01310127 ↗ |
| Known as | Bromefenac | “Drug: Bromefenac” NCT00758628 ↗ |
| Known as | Bromfenac (Xibrom) | “Bromfenac (Xibrom)” NCT00758199 ↗ |
| Known as | Bromfenac 0.09 % Ophthalmic Solution | “Bromfenac 0.09 % Ophthalmic Solution” NCT03597867 ↗ |
| Known as | Bromfenac Ophthalmic Solution | “Drug: Bromfenac Ophthalmic Solution” NCT01367249 ↗ |
| Known as | Bromfenac Sodium | “A Double-Masked Clinical Study To Determine The Aqueous Humor Concentration Of Bromfenac Sodium In Subjects Administered Multiple Topical Ocular Doses Of ISV-303 Or Bromday™...” NCT01387464 ↗ |
| Known as | ISV-101 | “ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution)” NCT01478555 ↗ |
| Known as | PRO-155 | “Drug: Bromfenac Other names: PRO-155” NCT01535443 ↗ |
| Known as | Prolensa | “Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD” NCT03886779 ↗1“Prolensa (bromfenac 0.07%)” NCT01847638 ↗ |
| Known as | Xibrom | “To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on...” NCT00698724 ↗4“Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)” NCT01021761 ↗ “2. Xibrom (Bromfenac)” NCT00469781 ↗ |
| Known as | Yellox | “Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery” NCT03597867 ↗ |
| Action | Inhibit | “Topical 0.1% Bromfenac Sodium for Intraoperative Pupil Dilation Maintenance and Prostaglandin E2 Inhibition” NCT02681679 ↗ |
| Modality | Other / unclassified | “NSAID” NCT03751059 ↗ |
| Route | Topical | “Topical bromfenac ophthalmic solution 0.1%” NCT00198445 ↗ |