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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New Formulation	NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation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.

Clinical Trial Conditions for Tobradex St

Condition Name

Condition Name for Tobradex St
Intervention	Trials
Cataract	6
Blepharitis	3
Inflammation	1

Condition MeSH

Condition MeSH for Tobradex St
Intervention	Trials
Cataract	7
Inflammation	4
Conjunctivitis	3

Clinical Trial Locations for Tobradex St

Trials by Country

Trials by Country for Tobradex St
Location	Trials
Italy	35
United States	9
Brazil	2
Greece	2
Singapore	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
Phase 4	3
Phase 3	10
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Tobradex St
Clinical Trial Phase	Trials
Completed	15
Unknown status	2
Withdrawn	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	11

TOBRADEX ST: Clinical Trials, Market Analysis, and Projections

Introduction to TOBRADEX ST

TOBRADEX ST, a formulation of tobramycin and dexamethasone ophthalmic suspension, has emerged as a significant treatment option for various ocular conditions, including blepharitis, blepharoconjunctivitis, and other steroid-responsive inflammatory ocular diseases. Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Efficacy and Safety

Clinical Trials Overview

A multicenter, randomized, investigator-masked, active-controlled study compared the efficacy and safety of TOBRADEX ST (tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05%) with azithromycin ophthalmic solution (1%) in treating moderate to severe blepharitis/blepharoconjunctivitis. The study involved 122 adult subjects, with 61 receiving TOBRADEX ST and 61 receiving azithromycin. The results showed a statistically significant lower mean global score for subjects treated with TOBRADEX ST compared to azithromycin at Day 8, indicating faster inflammation relief and effective treatment of acute blepharitis[1][4].

Key Findings

• Faster Inflammation Relief: TOBRADEX ST provided quicker relief from inflammation compared to azithromycin.
• Safety Profile: No serious adverse events were reported during the study, highlighting the safety of TOBRADEX ST.
• Clinical Profile: The study utilized standardized, validated photograph control scales, ensuring robust and reliable outcomes[1].

Novel Formulation and Technology

XanGen™ Technology

TOBRADEX ST incorporates XanGen™ technology, which uses pharmaceutical-grade xanthan gum to enhance the delivery and ocular surface retention of tobramycin and dexamethasone. This technology ensures that nearly all (97%) of the dexamethasone remains suspended after 24 hours, compared to just 39% for the non-ST formulation. This consistent delivery results in improved bactericidal activity and higher concentrations of the drug in tears[2][4].

Market Analysis

Current Market Size and Growth

The tobramycin eye drop market, which includes TOBRADEX ST, was valued at USD 0.90 billion in 2023. It is projected to grow to USD 2.4 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 13% during the forecast period of 2023-2031. This growth is driven by increasing clinical studies, enhanced scientific literature, and the rising demand for effective treatments for ocular infections like conjunctivitis[5].

Market Segments

The market is segmented by type (Tobramycin and Dexamethasone Ophthalmic Suspension, Tobramycin Ophthalmic Suspension, Other Tobramycin Combination), application (Adult, Children), end-users (Hospitals, Homecare, Specialty Clinics, Others), and distribution channels (Hospital Pharmacy, Online Pharmacy, Retail Pharmacy). The increasing understanding of the clinical efficacy of tobramycin in both adult and pediatric subjects is a key driver of market growth[5].

Projections and Future Outlook

Market Expansion

Given the strong clinical profile and the innovative XanGen™ technology, TOBRADEX ST is poised to capture a significant share of the growing tobramycin eye drop market. The product's ability to provide rapid relief from ocular surface inflammation with bacterial comorbidity makes it an attractive option for both patients and healthcare providers[2].

Educational Campaigns and Market Penetration

Eyevance Pharmaceuticals, the company behind TOBRADEX ST, is investing heavily in educational campaigns to inform eye care professionals about the product's benefits. This strategic approach is expected to enhance market penetration and adoption rates among healthcare providers[2].

Competitive Advantage

The unique formulation of TOBRADEX ST, which includes a lower concentration of dexamethasone without compromising efficacy, reduces the risk of intraocular pressure (IOP) spikes and blurriness. This makes it a preferred choice over other treatments, further solidifying its market position[2][3].

Key Takeaways

• Clinical Efficacy: TOBRADEX ST has demonstrated superior efficacy in treating moderate to severe blepharitis/blepharoconjunctivitis compared to azithromycin.
• Novel Technology: The XanGen™ technology enhances drug delivery and ocular surface retention, leading to improved bactericidal activity.
• Market Growth: The tobramycin eye drop market is expected to grow significantly, with TOBRADEX ST poised to capture a substantial share.
• Educational Campaigns: Ongoing educational efforts by Eyevance Pharmaceuticals are likely to increase adoption rates among healthcare providers.

FAQs

Q: What is TOBRADEX ST used for?

TOBRADEX ST is used for the treatment of steroid-responsive inflammatory ocular conditions where a corticosteroid is indicated and there is a risk of bacterial ocular infection.

Q: How does TOBRADEX ST differ from other formulations?

TOBRADEX ST uses XanGen™ technology, which enhances the delivery and ocular surface retention of tobramycin and dexamethasone, leading to improved efficacy and reduced side effects.

Q: What are the key findings from the clinical trials of TOBRADEX ST?

Clinical trials have shown that TOBRADEX ST provides faster inflammation relief and is more effective than azithromycin in treating moderate to severe blepharitis/blepharoconjunctivitis.

Q: What are the potential side effects of TOBRADEX ST?

While generally safe, prolonged use of TOBRADEX ST can lead to increased intraocular pressure and other corticosteroid-related side effects. However, the XanGen™ technology minimizes these risks by using a lower concentration of dexamethasone.

Q: What is the market outlook for TOBRADEX ST?

The market for tobramycin eye drops, including TOBRADEX ST, is projected to grow significantly, with a CAGR of 13% from 2023 to 2031, driven by its strong clinical profile and innovative technology.

Sources

1. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone (TobraDex ST) ophthalmic suspension 0.3%/0.05% compared to azithromycin (Azasite) ophthalmic solution (1%) in the treatment of moderate to severe blepharitis/blepharoconjunctivitis. PubMed.
2. Eyevance Pharmaceuticals launches TOBRADEX® ST in the United States. PR Newswire.
3. TOBRADEX ST - Santen Pharmaceutical. Santen Pharmaceutical.
4. The Value of TobraDex ST in Daily Practice. Ophthalmology 360.
5. Tobramycin Eye Drop Market Size, Statistics & Overview By 2031. Data Bridge Market Research.