Overview
Bimatoprost, also known as Latisse or Lumigan, belongs to a group of drugs called prostamides, which are synthetic structural analogs of prostaglandin. Bimatoprost, marketed by Allergan, is administered in both the ophthalmic solution and implant form. It has the ability to reduce ocular hypotension, proving effective in conditions such as ocular hypertension and glaucoma. Bimatoprost is also used to treat eyelash hypotrichosis, or sparse eyelash growth. It was initially approved by the FDA in 2001 for ocular hypertension and later approved for hypothrichosis in 2008, as eyelash growth became a desirable adverse effect for patients using this drug.
Indication
Bimatoprost is used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. These patients must be intolerant to other intraocular pressure lowering medications or inadequately responsive to other treatments. Bimatoprost is also indicated to treat eyelash hypotrichosis.
Associated Conditions
- Hypotrichosis of the eyelashes
- Increased Intra Ocular Pressure (IOP)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/07 | Phase 4 | Active, not recruiting | Federal University of São Paulo | ||
2024/02/20 | Phase 1 | Recruiting | |||
2023/11/08 | Phase 2 | Recruiting | Medstar Health Research Institute | ||
2023/11/07 | Phase 1 | Active, not recruiting | SpyGlass Pharma, Inc. | ||
2023/02/15 | Phase 1 | Completed | |||
2022/10/31 | Phase 1 | Completed | Ahmed Hassan Nouh MD | ||
2022/05/31 | Phase 3 | Completed | |||
2022/04/21 | N/A | NO_LONGER_AVAILABLE | |||
2022/04/19 | Phase 2 | Completed | |||
2021/07/29 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Akorn | 50383-912 | TOPICAL | 3 ug in 1 mL | 3/16/2022 | |
| Fosun Pharma USA Inc. | 72266-139 | OPHTHALMIC | 0.3 mg in 1 mL | 6/9/2022 | |
| LUPIN LIMITED | 57297-429 | OPHTHALMIC | 0.3 mg in 1 mL | 5/4/2016 | |
| Alembic Pharmaceuticals Inc. | 62332-507 | OPHTHALMIC | 0.3 mg in 1 mL | 3/24/2021 | |
| Gland Pharma Limited | 68083-296 | OPHTHALMIC | 0.3 mg in 1 mL | 4/12/2022 | |
| Fosun Pharma USA Inc. | 72266-140 | OPHTHALMIC | 0.3 mg in 1 mL | 6/9/2022 | |
| Gland Pharma Limited | 68083-439 | OPHTHALMIC | 0.3 mg in 1 mL | 4/12/2022 | |
| Micro Labs Limited | 42571-128 | OPHTHALMIC | 0.3 mg in 1 mL | 3/22/2024 | |
| Aurobindo Pharma Limited | 65862-802 | OPHTHALMIC | 0.3 mg in 1 mL | 7/17/2023 | |
| Akorn | 50383-908 | OPHTHALMIC | 0.3 mg in 1 mL | 3/7/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/8/2002 | ||
Authorised | 5/19/2006 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LUMIGAN (BIMATOPROST OPHTHALMIC SOLUTION) 0.01% | SIN14365P | SOLUTION, STERILE | 0.01% w/v | 6/13/2013 | |
| CAREPROST STERILE EYE DROPS 0.03% W/V | SIN15638P | SOLUTION, STERILE | 0.03%w/v | 2/27/2019 | |
| LUMIGAN PF (BIMATOPROST OPHTHALMIC SOLUTION) 0.03% | SIN16938P | SOLUTION, STERILE | 0.3 mg/mL | 1/30/2024 | |
| Ganfort Eye Drops | SIN13589P | SOLUTION, STERILE | 0.3mg/ml | 12/29/2008 | |
| GANFORT PF EYE DROPS (Bimatoprost 0.3mg/ml, Timolol 5.0mg/ml) | SIN14966P | SOLUTION, STERILE | 0.3 mg/ml | 3/11/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bimatoprost Ophthalmic Solution | 国药准字HJ20150484 | 化学药品 | 眼用制剂 | 2/17/2025 | |
| Bimatoprost Ophthalmic Solution | H20150484 | 化学药品 | 眼用制剂 | 6/10/2020 | |
| Bimatoprost Ophthalmic Solution | 国药准字H20213069 | 化学药品 | 眼用制剂 | 1/30/2021 | |
| Bimatoprost Ophthalmic Solution | 国药准字H20244103 | 化学药品 | 眼用制剂 | 6/25/2024 | |
| Bimatoprost Ophthalmic Solution | 国药准字H20244892 | 化学药品 | 眼用制剂 | 10/15/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ZIMED PRESERVATIVE FREE EYE DROPS SOLUTION 0.3MG/ML | N/A | N/A | N/A | 8/16/2024 | |
| GANFORT EYE DROPS | N/A | N/A | N/A | 3/15/2008 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LUMIGAN RC bimatoprost 100 microgram/mL eye drops bottle | 286206 | Medicine | A | 4/4/2018 | |
| VIZO-PF BIMATOPROST bimatoprost 300 microgram/mL eye drops bottle | 315400 | Medicine | A | 1/17/2020 | |
| LUMIPROST bimatoprost 300 microgram/mL eye drops bottle | 293319 | Medicine | A | 7/10/2018 | |
| GANFORT PF 0.3/5 bimatoprost 0.3 mg/mL and timolol (as maleate) 5.0 mg/mL eye drops | 211161 | Medicine | A | 11/13/2013 | |
| LUMITOPROST bimatoprost 300 microgram/mL eye drops bottle | 293325 | Medicine | A | 7/10/2018 | |
| LUMIVIS bimatoprost 300 microgram/mL eye drops bottle | 282341 | Medicine | A | 2/2/2017 | |
| VIZO-PF BIMATOTIM 0.3/5 | 336897 | Medicine | A | 8/12/2021 | |
| BIMATOPROST JNO bimatoprost 300 microgram/mL eye drops bottle | 288807 | Medicine | A | 3/14/2018 | |
| BIMPROZT bimatoprost 300 microgram/mL eye drops bottle | 288809 | Medicine | A | 3/14/2018 | |
| LUMIFOR bimatoprost 300 microgram/mL eye drops bottle | 282343 | Medicine | A | 2/2/2017 |
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