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Last Updated: April 10, 2025

CLINICAL TRIALS PROFILE FOR TOBREX


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505(b)(2) Clinical Trials for TOBREX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Formulation NCT00404937 ↗ Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle Withdrawn Alcon Research Phase 3 2006-12-01 The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

All Clinical Trials for TOBREX

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00695435 ↗ Tobramycin Tear Concentrations Completed Alcon Research Phase 1 2008-06-01 To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.
NCT00404937 ↗ Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle Withdrawn Alcon Research Phase 3 2006-12-01 The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

Clinical Trial Conditions for TOBREX

Condition Name

110-0.100.10.20.30.40.50.60.70.80.911.1Dry EyePost-surgical Inflammation[disabled in preview]
Condition Name for TOBREX
Intervention Trials
Dry Eye 1
Post-surgical Inflammation 1
[disabled in preview] 0
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1Dry Eye SyndromesInflammation[disabled in preview]
Condition MeSH for TOBREX
Intervention Trials
Dry Eye Syndromes 1
Inflammation 1
[disabled in preview] 0
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Clinical Trial Locations for TOBREX

Trials by Country

+
Trials by Country for TOBREX
Location Trials
United States 1
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Trials by US State

+
Trials by US State for TOBREX
Location Trials
Texas 1
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Clinical Trial Progress for TOBREX

Clinical Trial Phase

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3Phase 1[disabled in preview]
Clinical Trial Phase for TOBREX
Clinical Trial Phase Trials
Phase 3 1
Phase 1 1
[disabled in preview] 0
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1CompletedWithdrawn[disabled in preview]
Clinical Trial Status for TOBREX
Clinical Trial Phase Trials
Completed 1
Withdrawn 1
[disabled in preview] 0
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Clinical Trial Sponsors for TOBREX

Sponsor Name

trials000111112222Alcon Research[disabled in preview]
Sponsor Name for TOBREX
Sponsor Trials
Alcon Research 2
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Sponsor Type

100.0%0-0.200.20.40.60.811.21.41.61.822.2Industry[disabled in preview]
Sponsor Type for TOBREX
Sponsor Trials
Industry 2
[disabled in preview] 0
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Tobrex (Tobramycin): Clinical Trials, Market Analysis, and Projections

Introduction to Tobrex (Tobramycin)

Tobramycin, commonly known by the brand name Tobrex, is an aminoglycoside antibiotic used to treat various bacterial infections. It is particularly effective against infections caused by Pseudomonas aeruginosa and other gram-negative bacteria. Here, we will delve into the recent clinical trials, market analysis, and future projections for Tobrex.

Clinical Trials Update

Tobramycin in Cystic Fibrosis

The EVOLVE clinical trial evaluated the efficacy of Tobramycin PODHALER in patients with cystic fibrosis (CF) aged 6 to 21 years. This 24-week, randomized, double-blind trial showed significant improvements in lung function. Patients treated with Tobramycin PODHALER experienced a mean absolute change in FEV1 predicted of +6.38%, compared to -0.52% for the placebo group, resulting in a difference of 6.90% (95% CI: 2.40, 11.40)[1].

Tobramycin in Bronchiectasis

A phase 3, 16-week, multicenter, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of nebulized tobramycin inhalation solution (TIS) in adults with bronchiectasis and Pseudomonas aeruginosa infection. The trial found that TIS significantly reduced P. aeruginosa density and improved quality-of-life scores compared to the placebo group. Additionally, TIS reduced 24-hour sputum volume and sputum purulence scores[4].

Market Analysis

Global Market Size and Growth

The global Tobramycin eye drop market has been growing steadily. As of 2023, the market size was valued at approximately $12.21 billion and is expected to reach $19.05 billion by 2032, with a compound annual growth rate (CAGR) of nearly 5.07% between 2024 and 2032[2].

Another report indicates that the Tobramycin eye drop market was valued at $0.90 billion in 2023 and is projected to grow to $2.4 billion by 2031, with a CAGR of around 13% during this period[3].

Regional Market Performance

The North American market is anticipated to register the fastest CAGR due to increased production of Tobramycin eye drops in countries like the U.S. The aging population in this region is also a significant factor contributing to market growth[2].

Drivers and Opportunities

The clinical efficacy of Tobramycin eye drops in treating bacterial infections of the eye and eyelids is a primary driver of market growth. Increasing awareness about the effectiveness of Tobramycin, particularly in adult and pediatric patients, has boosted its uptake. Additionally, the rise in eye infections and the growing use of electronic equipment, which can lead to eye strain and infections, are driving the market forward[2][3].

Challenges

Despite the growth, the market faces challenges such as the adverse effects of Tobramycin on the eye and the increasing production costs. The scarce availability of raw materials can also hinder market expansion[2].

Market Projections

Future Growth

The Tobramycin eye drop market is expected to see significant growth in the coming years. By 2032, the market is projected to reach $19.05 billion, driven by the increasing demand for effective treatments for eye infections and the expanding aging population[2].

For the period 2024 to 2031, the market is expected to grow at a CAGR of around 13%, reaching $2.4 billion by 2031[3].

Segment Analysis

The market is segmented by type, application, and end-users. The segments include Tobramycin and Dexamethasone Ophthalmic Suspension, Tobramycin Ophthalmic Suspension, and other combinations. The application segments include adult and pediatric use, with end-users such as hospitals, homecare, specialty clinics, and others[3].

Key Takeaways

  • Clinical Efficacy: Tobramycin has shown significant efficacy in clinical trials for treating cystic fibrosis and bronchiectasis, as well as bacterial eye infections.
  • Market Growth: The global Tobramycin eye drop market is projected to grow substantially, driven by clinical effectiveness and increasing demand.
  • Regional Performance: North America is expected to be a key region for market growth due to high production and an aging population.
  • Challenges: The market faces challenges related to adverse effects and production costs.

FAQs

What is Tobramycin used for?

Tobramycin is an antibiotic used to treat various bacterial infections, including those caused by Pseudomonas aeruginosa. It is commonly used in the treatment of cystic fibrosis, bronchiectasis, and bacterial eye infections.

What are the key findings of the EVOLVE clinical trial?

The EVOLVE trial showed that Tobramycin PODHALER significantly improved lung function in patients with cystic fibrosis, with a mean absolute change in FEV1 predicted of +6.38% compared to -0.52% for the placebo group[1].

How is the global Tobramycin eye drop market expected to grow?

The global Tobramycin eye drop market is expected to grow from $12.21 billion in 2023 to $19.05 billion by 2032, with a CAGR of nearly 5.07% between 2024 and 2032[2].

What are the main drivers of the Tobramycin eye drop market?

The main drivers include the clinical efficacy of Tobramycin in treating bacterial eye infections, increasing awareness among patients, and the growing use of electronic equipment leading to eye strain and infections[2][3].

What challenges does the Tobramycin eye drop market face?

The market faces challenges such as adverse effects on the eye, increasing production costs, and the scarce availability of raw materials[2].

Sources

  1. Tobipodhalerhcp.com: Efficacy and Safety of TOBI PODHALER.
  2. Zion Market Research: Tobramycin Eye Drop Market Size, Share, Analysis, Growth.
  3. Data Bridge Market Research: Global Tobramycin Eye Drop Market Size, Statistics & Overview By 2031.
  4. PubMed: A Double-Blind Randomized Placebo-Controlled Phase 3 Trial of Nebulized Tobramycin Inhalation Solution in Adults with Bronchiectasis.
  5. OpenPR: Tobramycin Eye Drop Global Market Report 2024.

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