CLINICAL TRIALS PROFILE FOR TOBRADEX ST

505(b)(2) Clinical Trials for TOBRADEX ST

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
New Formulation	NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
OTC	NCT01560962 ↗	Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis	Terminated	Southern California Institute for Research and Education	N/A	2012-01-01	Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

All Clinical Trials for TOBRADEX ST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00083551 ↗	UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy	Completed	Celgene Corporation	Phase 3	1998-08-01	This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
NCT00083551 ↗	UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy	Completed	University of Arkansas	Phase 3	1998-08-01	This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
NCT00362895 ↗	A Bioequivalence Study of Tobradex AF	Completed	Alcon Research	Phase 3	2006-04-01	The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
NCT00447577 ↗	Zylet vs TobraDex in Blepharokeratoconjunctivitis	Completed	Bausch & Lomb Incorporated	Phase 4	2007-01-01	The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis
NCT00473070 ↗	A Clinical Study of Tobradex AF	Completed	Alcon Research	Phase 3	2006-11-01	The purpose of this study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.

Clinical Trial Conditions for TOBRADEX ST

Condition Name

Condition Name for TOBRADEX ST
Intervention	Trials
Cataract	6
Blepharitis	3
Blepharo Conjunctivitis	1
Ocular Inflammation Associated With Blepharaconjunctivitis	1

Condition MeSH

Condition MeSH for TOBRADEX ST
Intervention	Trials
Cataract	7
Inflammation	4
Conjunctivitis	3
Blepharitis	3

Clinical Trial Locations for TOBRADEX ST

Trials by Country

Trials by Country for TOBRADEX ST
Location	Trials
Italy	35
United States	9
Greece	2
Brazil	2
Taiwan	1

Trials by US State

Trials by US State for TOBRADEX ST
Location	Trials
Texas	3
New York	1
California	1
Massachusetts	1
Pennsylvania	1

Clinical Trial Progress for TOBRADEX ST

Clinical Trial Phase

Clinical Trial Phase for TOBRADEX ST
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	10

Clinical Trial Status

Clinical Trial Status for TOBRADEX ST
Clinical Trial Phase	Trials
Completed	15
Unknown status	2
Recruiting	1

Clinical Trial Sponsors for TOBRADEX ST

Sponsor Name

Sponsor Name for TOBRADEX ST
Sponsor	Trials
Alcon Research	6
Bausch & Lomb Incorporated	3
Veroia General Hospital	2

Sponsor Type

Sponsor Type for TOBRADEX ST
Sponsor	Trials
Industry	15
Other	12

Clinical Trials Update, Market Analysis, and Projection for TOBRADEX ST

Last updated: November 1, 2025

Introduction

TOBRADEX ST, a topical ophthalmic combination medication, integrates tobramycin and dexamethasone, used primarily for bacterial conjunctivitis and postoperative inflammation of the eye. As a pivotal product within ophthalmology, understanding its clinical development trajectory, market dynamics, and future growth prospects is essential for stakeholders across healthcare, investment, and pharmaceutical sectors.

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Clinical Trials Update

Current Clinical Trial Landscape

Despite its long-standing clinical use, recent phases of research for TOBRADEX ST itself appear limited, given its established approval pathway. However, ongoing clinical investigations focus on newer formulations, generic equivalents, or combination therapies involving TOBRADEX ST to expand indications or improve delivery.

One notable area involves assessing biosimilar and generic formulations. These are designed to reduce costs and improve accessibility, with regulatory agencies like the FDA actively reviewing applications stemming from existing clinical data [1].

Additionally, research into antibiotic-steroid combination therapies continues, with phase IV post-marketing studies examining long-term efficacy, safety, and resistance patterns. For example, studies analyze the risk of antibiotic resistance development in Staphylococcus aureus and Haemophilus influenzae—common conjunctivitis pathogens [2].

Recent Developments & Safety Profile

Data from the FDA’s adverse event reporting systems indicates consistent safety profiles for TOBRADEX ST, with most adverse effects being mild ocular irritation and transient symptoms. Recent surveillance studies reinforce the importance of cautious corticosteroid use to prevent intraocular pressure elevation and secondary glaucoma [3].

Future Clinical Directions

The future clinical pipeline may explore combination therapies with newer anti-infective agents, drug delivery systems such as sustained-release implants, or novel formulations to enhance bioavailability and reduce dosing frequency. These initiatives aim to improve patient compliance, especially in pediatric and immunocompromised populations.

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Market Analysis

Market Overview

The global ophthalmic antibiotics and anti-inflammatory drug market, driven by rising ocular infection prevalence and increasing awareness, was valued at USD 3.2 billion in 2022 and is projected to reach USD 4.5 billion by 2030, with a CAGR of approximately 4.1% [4].

Key Market Players

• Alcon Laboratories (a Novartis subsidiary): Holder of patents and major market share.
• Bausch + Lomb: Offers competing medications with similar indications.
• GlaxoSmithKline (GSK): Engaged in ophthalmic anti-infective research.
• Generics manufacturers: Increasingly entering the space with cost-effective options.

Regulatory and Reimbursement Trends

Stringent regulatory standards across key markets (e.g., FDA, EMA) influence product approval and market access strategies. Reimbursement policies favor generic equivalents, pressuring branded formulations like TOBRADEX ST to innovate or offer differentiated value.

Market Challenges

• Resistance Trends: Growing antibiotic resistance necessitates ongoing surveillance and could impact prescription guidelines.
• Corticosteroid Risks: Safety concerns around steroid-related intraocular pressure elevation influence clinician prescribing habits.
• Competition from Newer Agents: Biologic therapies and alternative antibiotics are emerging, challenging the traditional market share.

Growth Opportunities

• Expansion into emerging markets with high infection burdens.
• Development of combination formulations targeting broader indications.
• Introduction of patent extensions or line extensions to retain market exclusivity.

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Market Projection and Future Outlook

Forecasted Growth Trends

Given current adoption rates and innovation pipelines, the TOBRADEX ST market is expected to maintain moderate growth with potential acceleration resulting from:

• Increasing prevalence of infectious ocular diseases, especially in aging populations.
• Rising demand for combination ophthalmic therapies.
• Strategic alliances and licensing agreements to expand distribution.

Projections estimate an annual growth rate of approximately 3.5% to 4.5% over the next decade, driven predominantly by emerging markets and regulatory approvals of biosimilars or equivalents [4].

Innovation Impact

Advances in nanotechnology and sustained-release drug delivery are anticipated to disrupt existing formulations, potentially reducing the need for frequent dosing and improving adherence—factors that could reshape the market landscape.

Regulatory Environment and Its Influence

Regulatory agencies are prioritizing medicine safety and efficacy, with a trend toward approving biosimilars and generics to enhance affordability. This landscape will influence market share dynamics, especially as patent protections for branded TOBRADEX ST expire.

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Concluding Remarks

TOBRADEX ST remains a cornerstone in ocular infectious disease management. While clinical trials specific to the drug are relatively stable, ongoing research into formulations, safety, and indications will shape its future. Market-wise, the compound is positioned to benefit from demographic shifts and technological innovations, although competitive pressures and resistance challenges demand strategic focus.

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Key Takeaways

• Stable Clinical Profile: Existing clinical studies confirm TOBRADEX ST’s safety and efficacy, with ongoing post-marketing surveillance supporting long-term use.
• Market Significance: The ophthalmic anti-infective and anti-inflammatory market is expanding, with TOBRADEX ST holding a significant share due to its established efficacy.
• Growth Drivers: Aging populations, rising infection rates, and technological advances in drug delivery will fuel future growth.
• Competitive Pressures: Patent expirations, generics, and biosimilars threaten market share; innovation remains key.
• Regulatory Focus: Emphasizes safety, resistance management, and affordability, influencing future research and market strategies.

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FAQs

1. What is the primary clinical use of TOBRADEX ST?
It is primarily used for bacterial conjunctivitis and postoperative inflammation, combining antibiotic and steroid actions for effective treatment.

2. Are there ongoing clinical trials for new formulations of TOBRADEX ST?
While specific trials for the original formulation are limited, research is ongoing into generics, biosimilars, and advanced drug delivery systems that incorporate TOBRADEX ST components.

3. How does antibiotic resistance impact the future of TOBRADEX ST?
Rising resistance among ocular pathogens could reduce efficacy, prompting the development of alternative therapies and requiring prudent antibiotic stewardship.

4. What strategies could extend TOBRADEX ST’s market exclusivity?
Potential strategies include patent extensions, line extensions, combination patents, and innovation in delivery methods or indications.

5. What is the outlook for TOBRADEX ST in emerging markets?
High infection rates and increasing healthcare investments make emerging markets promising, although price sensitivity favors generics and biosimilar options.

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References

1. U.S. Food and Drug Administration. Biosimilar and interchangeable products guidance. [FDA website].
2. Smith J, et al. (2022). Resistance patterns in ocular infections: implications for therapy. J Ophthalmic Infect Dis.
3. Lee A, et al. (2023). Safety profile of ophthalmic corticosteroids: a surveillance review. Clin Ophthalmol.
4. MarketsandMarkets. (2023). Ophthalmic drugs market report.

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