CLINICAL TRIALS PROFILE FOR BIMATOPROST

505(b)(2) Clinical Trials for Bimatoprost

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01325337 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
OTC	NCT01325350 ↗	Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss	Completed	Allergan	Phase 2	2011-06-01	This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.
New Formulation	NCT01426113 ↗	A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma	Terminated	Allergan	Phase 3	2011-09-01	The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.

All Clinical Trials for Bimatoprost

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00187577 ↗	Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata	Completed	University of California, San Francisco	N/A	2005-06-01	This is a single center, randomized, investigator-masked study to determine the efficacy and safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in patients who have lost their eyelashes due to alopecia areata. These medications are FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer, darker, and thicker eyelashes with their use. In this study, patients will be asked to apply these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped applicator once a day.
NCT00273455 ↗	Lumigan Versus Cosopt	Completed	Pharmaceutical Research Network	Phase 4	2006-01-01	To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy
NCT00300443 ↗	Safety and Efficacy Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension	Completed	Allergan	Phase 2/Phase 3	2005-12-01	The purpose of this study is to assess the safety and efficacy of bimatoprost in patients with glaucoma or ocular hypertension
NCT00332059 ↗	Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension	Completed	Allergan	Phase 3	2003-05-01	The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension
NCT00332072 ↗	Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients Wtih Glaucoma or Ocular Hypertension	Completed	Allergan	Phase 3	2001-08-01	The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in the treatment of glaucoma or ocular hypertension
NCT00332540 ↗	Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension	Completed	Allergan	Phase 3	2001-08-01	The purpose of this study is to assess the safety and efficacy of Bimatoprost/Timolol Fixed Combination in patients with glaucoma or ocular hypertension

Clinical Trial Conditions for Bimatoprost

Condition Name

Condition Name for Bimatoprost
Intervention	Trials
Ocular Hypertension	71
Glaucoma	42
Glaucoma, Open-Angle	21
Open-Angle Glaucoma	12

Condition MeSH

Condition MeSH for Bimatoprost
Intervention	Trials
Glaucoma	76
Ocular Hypertension	74
Hypertension	58
Glaucoma, Open-Angle	44

Clinical Trial Locations for Bimatoprost

Trials by Country

Trials by Country for Bimatoprost
Location	Trials
United States	284
Germany	24
Italy	23
Canada	22
United Kingdom	22

Trials by US State

Trials by US State for Bimatoprost
Location	Trials
California	38
Texas	19
North Carolina	14
Georgia	14
Pennsylvania	14

Clinical Trial Progress for Bimatoprost

Clinical Trial Phase

Clinical Trial Phase for Bimatoprost
Clinical Trial Phase	Trials
Phase 4	48
Phase 3	30
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Bimatoprost
Clinical Trial Phase	Trials
Completed	105
Recruiting	6
Unknown status	4

Clinical Trial Sponsors for Bimatoprost

Sponsor Name

Sponsor Name for Bimatoprost
Sponsor	Trials
Allergan	75
Alcon Research	7
ForSight Vision5, Inc.	6

Sponsor Type

Sponsor Type for Bimatoprost
Sponsor	Trials
Industry	103
Other	42
NIH	2

Bimatoprost: Clinical Trials, Market Analysis, and Projections

Introduction to Bimatoprost

Bimatoprost is a prostaglandin analog widely used in the treatment of glaucoma and ocular hypertension, as well as in cosmetic applications for promoting eyelash growth. Here, we will delve into the latest clinical trials, market analysis, and projections for this versatile drug.

Clinical Trials Update

Bimatoprost Sustained-Release (SR) Implant

One of the significant advancements in bimatoprost therapy is the development of the Bimatoprost Sustained-Release (SR) implant. Allergan's New Drug Application (NDA) for this implant was accepted by the U.S. FDA in 2019. The ARTEMIS Phase 3 studies demonstrated that Bimatoprost SR reduced intraocular pressure (IOP) by 30% over a 12-week period, meeting non-inferiority criteria compared to timolol, a standard comparator. Notably, over 80% of patients remained treatment-free for at least 12 months after three administrations of the implant, highlighting its potential to revolutionize glaucoma treatment[1].

NCX 470: NO-Donating Bimatoprost Eye Drop

Nicox SA is currently conducting Phase 3 clinical trials for NCX 470, a novel NO-donating bimatoprost eye drop. The Denali trial, being conducted in the U.S. and China, aims to evaluate the efficacy of NCX 470 in lowering IOP in patients with open-angle glaucoma or ocular hypertension. As of the latest update, 80% of the target number of patients have been randomized, and completion of recruitment is expected by Q4 2024. This new formulation could offer enhanced efficacy and convenience for patients[4].

Market Analysis

Current Market Size and Growth

The bimatoprost market has been experiencing steady growth driven by several key factors. As of 2022, the global bimatoprost market size was valued at USD 1.5 billion and is projected to reach USD 2.5 billion by 2030, growing at a CAGR of 7.4% from 2024 to 2030[2].

Market Drivers

• Increasing Prevalence of Glaucoma: The rising incidence of glaucoma and other ocular hypertension conditions is a major driver for the demand of bimatoprost. In 2018, nearly 130 million people globally were living with glaucoma, a number expected to rise to 148 million by 2023[1][3].
• Aging Population: The global aging population contributes significantly to the increasing cases of age-related eye conditions such as glaucoma, thereby boosting the demand for bimatoprost[2][3].
• Advancements in Pharmaceutical Formulations: Innovations in drug delivery systems, such as sustained-release implants and NO-donating eye drops, enhance the efficacy and convenience of bimatoprost, driving market growth[1][4][5].
• Cosmetic Applications: The use of bimatoprost in aesthetic treatments for promoting eyelash growth has broadened its market scope, contributing to increased demand[2][3].

Market Segmentation

The bimatoprost market is primarily segmented into two main applications:

• Glaucoma: Bimatoprost is used to reduce intraocular pressure in patients with glaucoma, which is a chronic eye condition that can lead to vision loss if untreated[3].
• Hypotrichosis: Bimatoprost is also used cosmetically to promote eyelash growth in individuals with inadequate or thinning eyelashes[3].

Regional Analysis

North America remains the dominant region for the bimatoprost market, but significant growth is also being witnessed in the Asia-Pacific region due to improving healthcare infrastructure and increasing awareness of eye health[2].

Market Projections

Future Growth Trends

The bimatoprost market is expected to expand significantly in the coming years, driven by both therapeutic and cosmetic applications. Here are some key projections:

• Market Size: The market is projected to reach USD 2.5 billion by 2030, growing at a CAGR of 7.4% from 2024 to 2030[2].
• Technological Advancements: Continued innovations in drug delivery systems and formulations are expected to enhance the efficacy and safety profile of bimatoprost, opening up new market opportunities[1][4][5].
• Expanding Healthcare Infrastructure: Improving healthcare infrastructure, especially in emerging markets, will increase the accessibility and affordability of bimatoprost-based products, driving further market expansion[2][3].

Challenges and Opportunities

While the market for bimatoprost is poised for significant growth, there are also challenges to be addressed:

• Patent Expiration: Navigating patent expiration issues will be crucial in maintaining competitiveness in the market[5].
• Pricing Pressures: Addressing pricing pressures in a highly competitive market environment will be essential for market players[5].
• Strategic Partnerships: Forming strategic partnerships with ophthalmologists and leveraging digital marketing strategies can help increase public awareness and acceptance of bimatoprost products[5].

Key Takeaways

• Bimatoprost is a versatile drug with significant therapeutic and cosmetic applications.
• The Bimatoprost Sustained-Release (SR) implant and NCX 470 NO-donating eye drop are promising new formulations in clinical trials.
• The market is driven by the increasing prevalence of glaucoma, an aging population, and advancements in pharmaceutical formulations.
• The global bimatoprost market is projected to reach USD 2.5 billion by 2030, growing at a CAGR of 7.4%.
• Challenges include navigating patent expirations and addressing pricing pressures, while opportunities lie in strategic partnerships and digital marketing.

FAQs

What is Bimatoprost used for?

Bimatoprost is primarily used to treat increased intraocular pressure in patients with glaucoma or ocular hypertension. It is also used cosmetically to promote eyelash growth.

What are the latest clinical trials for Bimatoprost?

The latest clinical trials include the ARTEMIS Phase 3 studies for the Bimatoprost Sustained-Release (SR) implant and the Denali Phase 3 trial for NCX 470, a NO-donating bimatoprost eye drop.

What is the projected market size for Bimatoprost by 2030?

The global bimatoprost market is projected to reach USD 2.5 billion by 2030, growing at a CAGR of 7.4% from 2024 to 2030.

What are the main drivers of the Bimatoprost market?

The main drivers include the increasing prevalence of glaucoma, an aging global population, advancements in pharmaceutical formulations, and growing demand for cosmetic treatments.

What are the challenges facing the Bimatoprost market?

Challenges include navigating patent expirations, addressing pricing pressures in a competitive market, and ensuring continued innovation in formulations and delivery systems.

Sources

1. U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release (SR) - Biospace
2. Bimatoprost Market Size, Growth and Forecast from 2024 - 2031 - GitHub
3. Bimatoprost Eye Drop Market Size, Share, Trends & Forecast - Verified Market Research
4. Nicox publishes results of Phase 3 trial of NCX 470 for treatment of glaucoma - Ophthalmology Times
5. Bimatoprost API Market Size & Share 2025-2030 - 360iResearch