Bimatoprost

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
Triplenex (triple Fixed Combination) Use Evaluation in Patients with Glaucoma	2025/01/07	NCT06761313	Phase 4	Active, not recruiting	Federal University of São Paulo
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes	2024/02/20	NCT06267274	Phase 1	Recruiting	Amneal Pharmaceuticals, LLC
Treatment of Hypopigmented Scars With Bimatoprost	2023/11/08	NCT06122090	Phase 2	Recruiting	Medstar Health Research Institute
Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution	2023/11/07	NCT06120842	Phase 1	Active, not recruiting	SpyGlass Pharma, Inc.
Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers	2023/02/15	NCT05729594	Phase 1	Completed	Laboratoires Thea
Combined CO2 Fractional Laser With Bimatoprost 0.03% Treatment of Alopecia Areata	2022/10/31	NCT05600673	Phase 1	Completed	Ahmed Hassan Nouh MD
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% in Ocular Hypertensive or Glaucomatous Patients	2022/05/31	NCT05397600	Phase 3	Completed	Laboratoires Thea
Expanded Access to Bimatoprost (Durysta)	2022/04/21	NCT05338606	N/A	NO_LONGER_AVAILABLE	AbbVie
A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)	2022/04/19	NCT05335122	Phase 2	Completed	Ocular Therapeutix, Inc.
Intraocular Pressure Reduction Efficacy of Rhopressa and Lumigan in Normal Tension Glaucoma	2021/07/29	NCT04981886	Phase 4	UNKNOWN	Salus University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bimatoprost	Akorn	50383-912	TOPICAL	3 ug in 1 mL	3/16/2022
Bimatoprost	Fosun Pharma USA Inc.	72266-139	OPHTHALMIC	0.3 mg in 1 mL	6/9/2022
bimatoprost	LUPIN LIMITED	57297-429	OPHTHALMIC	0.3 mg in 1 mL	5/4/2016
Bimatoprost	Alembic Pharmaceuticals Inc.	62332-507	OPHTHALMIC	0.3 mg in 1 mL	3/24/2021
Bimatoprost	Gland Pharma Limited	68083-296	OPHTHALMIC	0.3 mg in 1 mL	4/12/2022
Bimatoprost	Fosun Pharma USA Inc.	72266-140	OPHTHALMIC	0.3 mg in 1 mL	6/9/2022
Bimatoprost	Gland Pharma Limited	68083-439	OPHTHALMIC	0.3 mg in 1 mL	4/12/2022
BIMATOPROST	Micro Labs Limited	42571-128	OPHTHALMIC	0.3 mg in 1 mL	3/22/2024
Bimatoprost	Aurobindo Pharma Limited	65862-802	OPHTHALMIC	0.3 mg in 1 mL	7/17/2023
Bimatoprost	Akorn	50383-908	OPHTHALMIC	0.3 mg in 1 mL	3/7/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Lumigan	AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany	Authorised	3/8/2002
Ganfort	AbbVie Deutschland GmbH & Co. KG,Knollstrasse,67061 Ludwigshafen,Germany	Authorised	5/19/2006

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LUMIGAN (BIMATOPROST OPHTHALMIC SOLUTION) 0.01%	Allergan Pharmaceuticals Ireland	SIN14365P	SOLUTION, STERILE	0.01% w/v	6/13/2013
CAREPROST STERILE EYE DROPS 0.03% W/V	SUN PHARMACEUTICAL MEDICARE LIMITED	SIN15638P	SOLUTION, STERILE	0.03%w/v	2/27/2019
LUMIGAN PF (BIMATOPROST OPHTHALMIC SOLUTION) 0.03%	Allergan Pharmaceuticals Ireland	SIN16938P	SOLUTION, STERILE	0.3 mg/mL	1/30/2024
Ganfort Eye Drops	Allergan Pharmaceuticals Ireland	SIN13589P	SOLUTION, STERILE	0.3mg/ml	12/29/2008
GANFORT PF EYE DROPS (Bimatoprost 0.3mg/ml, Timolol 5.0mg/ml)	Allergan Pharmaceuticals Ireland	SIN14966P	SOLUTION, STERILE	0.3 mg/ml	3/11/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
ZIMED PRESERVATIVE FREE EYE DROPS SOLUTION 0.3MG/ML	N/A	DCH Auriga (Hong Kong) Limited	N/A	N/A	8/16/2024
GANFORT EYE DROPS	N/A	Allergan Hong Kong Limited	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	AbbVie Pty Ltd	Medicine	A	4/4/2018
VIZO-PF BIMATOPROST bimatoprost 300 microgram/mL eye drops bottle	315400	AFT Pharmaceuticals Pty Ltd	Medicine	A	1/17/2020
LUMIPROST bimatoprost 300 microgram/mL eye drops bottle	293319	Arrotex Pharmaceuticals Pty Ltd	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	AbbVie Pty Ltd	Medicine	A	11/13/2013
LUMITOPROST bimatoprost 300 microgram/mL eye drops bottle	293325	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/10/2018
LUMIVIS bimatoprost 300 microgram/mL eye drops bottle	282341	AbbVie Pty Ltd	Medicine	A	2/2/2017
VIZO-PF BIMATOTIM 0.3/5	336897	AFT Pharmaceuticals Pty Ltd	Medicine	A	8/12/2021
BIMATOPROST JNO bimatoprost 300 microgram/mL eye drops bottle	288807	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/14/2018
BIMPROZT bimatoprost 300 microgram/mL eye drops bottle	288809	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/14/2018
LUMIFOR bimatoprost 300 microgram/mL eye drops bottle	282343	AbbVie Pty Ltd	Medicine	A	2/2/2017

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LATISSE	Abbvie Corporation	02350939	Solution - Topical	0.03 % / W/V	11/1/2010
LUMIGAN	Allergan, Inc.	02245860	Solution - Ophthalmic	0.03 %	5/24/2002
LUMIGAN RC	Abbvie Corporation	02324997	Solution - Ophthalmic	0.01 % / W/V	6/16/2009
APO-BIMATOPROST	Apotex Inc	02356279	Solution - Ophthalmic	0.03 % / W/V	N/A
ZIMED PF	aequus pharmaceuticals inc.	02533464	Solution - Ophthalmic	0.03 % / W/V	9/12/2023
APO-BIMATOPROST	Apotex Inc	02402505	Solution - Topical	0.03 % / W/V	N/A
LUMIGAN PF	Allergan, Inc.	02400162	Solution - Ophthalmic	0.03 % / W/V	N/A
VISTITAN	Sandoz Canada, Inc.	02429063	Solution - Ophthalmic	0.03 % / W/V	5/13/2016

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LUMIGAN 0,3 mg/ml COLIRIO EN SOLUCION	Abbvie Deutschland Gmbh & Co. Kg	02205001	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
BIMATOPROST APOTEX 0,1 MG/ML COLIRIO EN SOLUCION	Apotex Europe B.V.	79237	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
BIMI 0,3 MG/ML COLIRIO EN SOLUCION	Brill Pharma S.L.	85717	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
GANFORT 0,3 MG/ML + 5 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS	Abbvie Deutschland Gmbh & Co. Kg	106340004IP1	COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS	Medicamento Sujeto A Prescripción Médica	Commercialized
BIMATOPROST STADA 0,3 MG/ML COLIRIO EN SOLUCION	Laboratorio Stada S.L.	80646	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
BIMATOPROST/TIMOLOL TEVA 0,3 MG/ML + 5 MG/ML COLIRIO EN SOLUCION	Teva Pharma S.L.U.	82259	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
AMIRIOX 0,3 MG/ML COLIRIO EN SOLUCION	Sifi S.P.A.	86389	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Commercialized
VISUBLEND 0,3 MG/ML + 5 MG/ML COLIRIO EN SOLUCION	Visufarma S.P.A.	86416	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
BIMATOPROST/TIMOLOL STADA 0,3 MG/ML + 5 MG/ML COLIRIO EN SOLUCION	Laboratorio Stada S.L.	82334	COLIRIO EN SOLUCIÓN	Medicamento Sujeto A Prescripción Médica	Not Commercialized
GANFORT 0,3 MG/ML + 5 MG/ML COLIRIO EN SOLUCION EN ENVASE UNIDOSIS	Abbvie Deutschland Gmbh & Co. Kg	106340004	COLIRIO EN SOLUCIÓN EN ENVASE UNIDOSIS	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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