Overview
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Ophthalmic NSAIDs are becoming a cornerstone for the management of ocular pain and inflammation. Their well-characterized anti-inflammatory activity, analgesic property, and established safety record have also made NSAIDs an important tool for optimizing surgical outcomes. Non-ophthalmic formulations of bromfenac were withdrawn in the US in 1998 due to cases of severe liver toxicity.
Background
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Ophthalmic NSAIDs are becoming a cornerstone for the management of ocular pain and inflammation. Their well-characterized anti-inflammatory activity, analgesic property, and established safety record have also made NSAIDs an important tool for optimizing surgical outcomes. Non-ophthalmic formulations of bromfenac were withdrawn in the US in 1998 due to cases of severe liver toxicity.
Indication
For the treatment of postoperative inflammation in patients who have undergone cataract extraction.
Associated Conditions
- Eye Pain
- Ocular Inflammation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/20 | Phase 4 | Completed | Inas Abd | ||
2022/11/23 | Phase 4 | Active, not recruiting | Nicole Fram M.D. | ||
2021/12/15 | Phase 3 | Terminated | Luigi Rondas | ||
2021/11/04 | Phase 2 | Recruiting | |||
2021/08/16 | Phase 1 | UNKNOWN | Optall Vision | ||
2021/06/25 | Phase 4 | Completed | Klinički Bolnički Centar Zagreb | ||
2020/04/13 | Phase 4 | Completed | |||
2019/07/17 | Phase 4 | Completed | |||
2019/03/22 | Phase 4 | Completed | |||
2018/11/23 | Phase 4 | UNKNOWN | Cindy Hutnik |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Physicians Total Care, Inc. | 54868-6301 | OPHTHALMIC | 0.9 mg in 1 mL | 10/3/2011 | |
| Physicians Total Care, Inc. | 54868-6343 | OPHTHALMIC | 1.035 mg in 1 mL | 4/17/2012 | |
| Lupin Pharmaceuticals, Inc. | 68180-434 | OPHTHALMIC | 0.75 mg in 1 mL | 3/15/2024 | |
| Imprimis NJOF, LLC | 71384-505 | OPHTHALMIC | 0.75 mg in 1 mL | 1/19/2018 | |
| Sun Pharmaceutical Industries, Inc. | 49708-754 | OPHTHALMIC | 0.76 mg in 1 mL | 4/14/2023 | |
| Gland Pharma Limited | 68083-313 | OPHTHALMIC | 0.9 mg in 1 mL | 3/31/2020 | |
| Lupin Pharmaceuticals, Inc. | 68180-433 | OPHTHALMIC | 0.805 mg in 1 mL | 3/15/2024 | |
| Lupin Pharmaceuticals, Inc. | 68180-436 | OPHTHALMIC | 0.9 mg in 1 mL | 3/15/2024 | |
| Bausch & Lomb Incorporated | 24208-602 | OPHTHALMIC | 0.7 mg in 1 mL | 1/31/2023 | |
| ARMAS PHARMACEUTICALS INC. | 72485-649 | OPHTHALMIC | 1.035 mg in 1 mL | 10/26/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bromfenac Sodium Eye Drops | 国药准字H20244468 | 化学药品 | 眼用制剂 | 7/22/2024 | |
| Bromfenac Sodium Eye Drops | 国药准字H20253042 | 化学药品 | 眼用制剂 | 1/2/2025 | |
| Bromfenac Sodium Eye Drops | 国药准字H20253221 | 化学药品 | 眼用制剂 | 1/14/2025 | |
| Bromfenac Sodium Eye Drops | 国药准字H20223699 | 化学药品 | 眼用制剂 | 9/30/2022 | |
| Bromfenac Sodium Eye Drops | 国药准字H20244161 | 化学药品 | 眼用制剂 | 6/25/2024 | |
| Bromfenac Sodium Eye Drops | 国药准字H20244569 | 化学药品 | 眼用制剂 | 7/30/2024 | |
| Bromfenac Sodium Eye Drops | 国药准字H20234193 | 化学药品 | 眼用制剂 | 9/28/2023 | |
| Bromfenac Sodium Eye Drops | 国药准字H20253220 | 化学药品 | 眼用制剂 | 1/14/2025 | |
| Bromfenac Sodium Eye Drops | 国药准字H20243868 | 化学药品 | 眼用制剂 | 6/4/2024 | |
| Bromfenac Sodium Eye Drops | 国药准字H20244284 | 化学药品 | 眼用制剂 | 6/28/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||