CLINICAL TRIALS PROFILE FOR LUMIGAN

All Clinical Trials for Lumigan

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
NCT00705757 ↗	The Effects of Xalatan, Travatan and Lumigan on Skin Pigmentation Near the Eye	Completed	Summa Health System	Phase 4	2008-03-01	The purpose of this study is to study changes in skin color that may be caused by using one of the three eye medicines: Xalatan, Travatan or Lumigan.
NCT00773136 ↗	Eyelash Growth From Application of Bimatoprost in Gel Suspension to the Base of the Eyelashes	Completed	University of Miami	N/A	2008-02-01	Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.
NCT00847483 ↗	Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-weeks, Masked Evaluator, Phase IV Multi-center Study in the US	Completed	Pfizer	Phase 4	2002-01-01	Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost

Clinical Trial Conditions for Lumigan

Condition Name

Condition Name for Lumigan
Intervention	Trials
Ocular Hypertension	31
Glaucoma	15
Glaucoma, Open-Angle	11
Open-Angle Glaucoma	5

Condition MeSH

Condition MeSH for Lumigan
Intervention	Trials
Glaucoma	31
Ocular Hypertension	31
Hypertension	23
Glaucoma, Open-Angle	22

Clinical Trial Locations for Lumigan

Trials by Country

Trials by Country for Lumigan
Location	Trials
United States	66
Canada	6
Japan	4
Germany	3
Belgium	2

Trials by US State

Trials by US State for Lumigan
Location	Trials
California	9
North Carolina	5
Florida	5
Texas	5
New Jersey	3

Clinical Trial Progress for Lumigan

Clinical Trial Phase

Clinical Trial Phase for Lumigan
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	9
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Lumigan
Clinical Trial Phase	Trials
Completed	34
Not yet recruiting	4
Unknown status	3

Clinical Trial Sponsors for Lumigan

Sponsor Name

Sponsor Name for Lumigan
Sponsor	Trials
Allergan	24
Laboratoires Thea	4
Alcon Research	3

Sponsor Type

Sponsor Type for Lumigan
Sponsor	Trials
Industry	38
Other	14
NIH	1

LUMIGAN: Clinical Trials, Market Analysis, and Projections

Introduction to LUMIGAN

LUMIGAN, a bimatoprost ophthalmic solution, is a widely used medication for reducing elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Efficacy and Safety Studies

One of the significant clinical trials for LUMIGAN involved a 12-month, prospective, randomized, double-masked, parallel-group, multicenter, phase 3 study. This study compared the efficacy of LUMIGAN 0.01%, LUMIGAN 0.0125%, and LUMIGAN 0.03% in patients with glaucoma or ocular hypertension. The results showed that LUMIGAN 0.01% demonstrated equivalent IOP-lowering efficacy compared to the 0.03% formulation, with consistent IOP reduction over 12 months[1].

Recent and Ongoing Trials

A recent clinical trial aims to assess the non-inferiority of T4032 (unpreserved bimatoprost 0.01%) compared to LUMIGAN 0.01% in terms of efficacy. This study involves 684 participants and is designed to evaluate whether the unpreserved formulation can match the efficacy of the preserved LUMIGAN 0.01% solution[4].

Market Analysis

Patent Protection and Generic Versions

LUMIGAN is protected by multiple patents, with some set to expire in 2025 and 2027. A significant patent infringement lawsuit ruled in favor of Allergan, ensuring that the patents for LUMIGAN 0.01% remain in effect until their expiration dates. This ruling prevented generic versions from being approved until the patents expire[5].

Despite this, a generic version of LUMIGAN (bimatoprost) was approved by APOTEX in 2014, but this applies to the 0.03% formulation. The unique formulation of LUMIGAN 0.01%, which reduces side effects such as red eye, has been a key factor in maintaining its patent protection[2].

Market Dynamics and Pricing

The market dynamics for LUMIGAN are influenced by its efficacy, safety profile, and the presence of generic competitors. The FDA's approval of LUMIGAN as a first-line treatment for elevated IOP in open-angle glaucoma or ocular hypertension has solidified its position in the market. The drug's ease of use and once-daily dosing have made it a preferred choice among eye care professionals[3].

Global Sales and Revenue

LUMIGAN has generated significant revenue since its introduction. While exact global sales figures are not provided here, the drug's widespread use and first-line treatment status indicate substantial market presence. The approval of generic versions, however, is expected to impact future revenue as more affordable alternatives become available[2].

Projections and Future Outlook

Patent Expiration and Generic Competition

The expiration of LUMIGAN's patents in 2025 and 2027 will likely lead to increased generic competition. This could reduce the market share and revenue for the branded version, as generic alternatives become more widely available and potentially more affordable[5].

Market Share and Pricing Strategies

To maintain market share, Allergan (now part of AbbVie) may need to adjust pricing strategies or develop new formulations that offer additional benefits over generic versions. The company's ability to innovate and adapt to changing market conditions will be crucial in maintaining its competitive edge.

Emerging Trends and Technologies

The ophthalmic drug market is evolving with advancements in drug delivery systems and new therapeutic agents. LUMIGAN's position in this market will depend on its ability to remain a gold standard for IOP reduction while also addressing emerging trends such as preservative-free formulations and combination therapies.

Side Effects and Safety Profile

LUMIGAN is known to cause changes to pigmented tissues, including increased pigmentation of the iris, periorbital tissue, and eyelashes. These changes are expected to increase as long as the medication is administered. While some of these changes are reversible upon discontinuation, pigmentation of the iris is likely to be permanent[3].

Key Takeaways

• Clinical Efficacy: LUMIGAN 0.01% has demonstrated equivalent IOP-lowering efficacy to the 0.03% formulation in clinical trials.
• Patent Protection: Patents for LUMIGAN 0.01% are set to expire in 2025 and 2027, which will impact its market exclusivity.
• Market Dynamics: The drug's first-line treatment status and once-daily dosing have made it a preferred choice, but generic competition will increase post-patent expiration.
• Future Outlook: The company will need to innovate and adjust pricing strategies to maintain market share.
• Safety Profile: LUMIGAN can cause changes to pigmented tissues, some of which are permanent.

FAQs

What is LUMIGAN used for?

LUMIGAN is used for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension[3].

What are the common side effects of LUMIGAN?

Common side effects include increased pigmentation of the iris, periorbital tissue, and eyelashes. Some of these changes can be permanent[3].

When do the patents for LUMIGAN expire?

The patents for LUMIGAN 0.01% are set to expire in 2025 and 2027[5].

Is there a generic version of LUMIGAN available?

Yes, a generic version of LUMIGAN (bimatoprost 0.03%) was approved in 2014, but the 0.01% formulation remains under patent protection until its expiration dates[2].

How does LUMIGAN compare to other IOP-lowering medications?

LUMIGAN has been reported to be as effective as other IOP-lowering medications and is preferred for its once-daily dosing and safety profile[1][3].

Sources

1. LUMIGAN® (bimatoprost ophthalmic solution) 0.01%. Lumigan.com.
2. Lumigan. DrugPatentWatch.com.
3. Allergan Inc. Announces FDA Approval Of LUMIGAN(R) As First-Line Treatment For Elevated Eye Pressure In Open-Angle Glaucoma. Biospace.com.
4. Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus LUMIGAN(R) 0.01%. Veeva.com.
5. Allergan wins patent fight for Lumigan 0.01%. American Academy of Ophthalmology.