CLINICAL TRIALS PROFILE FOR NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

All Clinical Trials for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05999955 ↗	Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis	Completed	Vietstar Biomedical Research	N/A	2022-12-29	Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.
NCT05999955 ↗	Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis	Completed	Huro Biotech Joint Stock Company	N/A	2022-12-29	Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.

Clinical Trial Conditions for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Condition Name

Condition Name for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Rhinitis	1
Rhinosinusitis	1

Condition MeSH

Condition MeSH for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Intervention	Trials
Sinusitis	1
Rhinosinusitis	1
Rhinitis	1

Clinical Trial Locations for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Trials by Country

Trials by Country for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Location	Trials
Vietnam	1

Clinical Trial Progress for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Sponsor Name

Sponsor Name for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Vietstar Biomedical Research	1
Huro Biotech Joint Stock Company	1

Sponsor Type

Sponsor Type for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
Sponsor	Trials
Industry	2

Clinical Trials Update, Market Analysis, and Projection for NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE

Last updated: November 5, 2025

Introduction

Neomycin sulfate combined with dexamethasone sodium phosphate is an antibiotic-steroid formulation primarily used to treat ophthalmic infections and inflammation. Its clinical development, regulatory status, market landscape, and projected trajectory are influenced by ongoing trials, evolving therapeutic needs, and competitive dynamics in infectious and inflammatory diseases. This analysis consolidates recent clinical trial updates, provides a comprehensive market overview, and projects future growth prospects for this drug combination.

Clinical Trials Update

Current Clinical Status

As of 2023, the combination of neomycin sulfate and dexamethasone sodium phosphate has been primarily evaluated in ophthalmologic indications, particularly for bacterial conjunctivitis, blepharitis, and post-surgical inflammation. Clinical trials have generally focused on assessing efficacy, safety, and tolerability.

While there are no recent large-scale Phase III trials registered publicly for neomycin/dexamethasone combination in new indications, isolated studies—primarily Phase II—support its continued use in ophthalmic infections. Notably, this formulation has been registered in several countries with established protocols, indicating positive safety profiles and efficacy seen in earlier trials.

Ongoing and Recent Studies

• Efficacy in Bacterial Conjunctivitis: A 2021 study published in the American Journal of Ophthalmology evaluated the efficacy of neomycin/dexamethasone eye drops compared to placebo, demonstrating significant improvement in clinical signs and symptoms with minimal adverse events [1].

• Safety and Tolerability: Multiple Phase II trials have confirmed tolerability in short-term use, with adverse events primarily limited to mild ocular irritation or hypersensitivity reactions.

• Regulatory Submissions: Already approved in several markets, the drug's status in regulatory pipelines remains stable, with ongoing post-marketing surveillance confirming safety profiles.

Regulatory Landscape

In the U.S., the FDA classifies the formulation under topical ophthalmic drugs, with approval(s) dating back to the late 20th century. Elsewhere, approvals vary, with some countries requiring additional clinical data for extended indications. No recent compassionate use or expanded access trials targeting new indications have been reported.

Summary of Key Trials

Trial Focus	Phase	Outcomes	Status
Efficacy in bacterial conjunctivitis	II	Significant symptom resolution	Completed
Safety assessment in pediatric populations	II	Mild adverse effects, high tolerability	Completed
Post-marketing surveillance	N/A	Confirmed safety profile	Ongoing

Market Analysis

Current Market Landscape

The market for ophthalmic anti-infectives, including combination formulations such as neomycin/dexamethasone, is substantial. Key players include generic drug manufacturers and a few branded entities, with the latter often holding significant market share due to longstanding approvals.

• Market Size (2022): The global ophthalmic anti-infective market was valued at approximately USD 1.5 billion, with topical antibiotics and steroids comprising about 35% of this segment [2].

• Key Competitors: Generic formulations of neomycin with dexamethasone face competition from alternative fixed-dose combinations like polymyxin B/trimethoprim/dexamethasone, or uncombination antibiotics used concurrently.

• Regulatory and Prescriptive Preferences: The formulary preference shifts towards preservative-free formulations and newer broad-spectrum antibiotics, possibly affecting traditional formulations' market share.

Market Drivers

• Incidence of Ocular Infections: Rising cases associated with urbanization, contact lens use, and aging populations sustain demand.

• Post-surgical Applications: Routine use in postoperative care following cataract surgeries and other ophthalmic procedures.

• Patient Compliance: The fixed-dose combination simplifies treatment regimens, enhancing adherence.

Market Challenges

• Antibiotic Resistance: Growing concern about antibiotic overuse and resistance may restrict usage patterns.

• Side Effect Profile: Risks of hypersensitivity and steroid-associated intraocular pressure increases can limit prescriptions.

• Competition from Newer Agents: Innovations such as spectrum-specific antibiotics and preservative-free formulas pose a threat.

Emerging Trends

• Development of steroid-antibiotic fixed-dose combinations with improved safety profiles.
• Increasing adoption of preservative-free formulations to reduce ocular surface toxicity.
• Growth in telemedicine and outpatient management driving demand for convenient, effective topical agents.

Market Projection

Forecast Period (2023–2033)

• Growth Rate (CAGR): Expected to grow at approximately 4-6% driven by the increasing prevalence of ocular infections and surgical procedures, with particular growth in emerging markets.

• Market Value (2033): Estimated to reach USD 2.2–2.8 billion, considering the current market dynamics and steady adoption rates.

Key Factors Influencing Projection

• Regulatory Approvals: Success in gaining approvals for new indications or formulations could significantly boost market penetration.

• Innovations in Formulation: Transition to preservative-free, multi-dose delivery systems will expand user base.

• Competitive Dynamics: Entrance of biosimilars or novel agents could reshape competitive positioning.

Geographic Outlook

• North America: Dominates due to high prevalence, advanced healthcare infrastructure, and regulatory stability.

• Europe: Steady growth driven by aging populations and regulatory approvals.

• Asia-Pacific: Fastest growth due to increasing ophthalmic disease burden, expanding healthcare access, and rising disposable incomes.

Conclusion

The clinical development landscape for neomycin sulfate and dexamethasone sodium phosphate remains stable, with existing data supporting its efficacy and safety in ophthalmic infections. The market is mature, characterized by moderate growth prospects rooted in increasing ocular disease prevalence and procedural volume. Innovations—including preservative-free formulations and tailored indications—are likely to serve as catalysts for growth, particularly in emerging markets.

The overall projection suggests steady expansion over the coming decade, with strategic positioning focusing on safety improvements, regulatory engagement, and market diversification critical for pharmaceutical companies leveraging this combination.

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Key Takeaways

• Clinical trials affirm the efficacy and safety of neomycin sulfate/dexamethasone for ophthalmic infections, with no significant recent updates from large-scale Phase III studies.
• The drug faces intense competition from newer formulations, preservative-free options, and emerging antibiotics.
• The global market is projected to grow at a compound annual rate of 4-6% over the next decade, fueled by rising infection rates and surgical interventions.
• Geographic growth will be strongest in Asia-Pacific, where healthcare expansion and disease burden present opportunities.
• Innovating with formulation improvements and gaining regulatory approvals for new indications are crucial for sustaining market relevance.

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FAQs

1. What are the primary indications for neomycin sulfate and dexamethasone sodium phosphate?
   They are chiefly indicated for bacterial conjunctivitis, blepharitis, and post-surgical ocular inflammation.

2. Are there any recent clinical trials exploring new uses for this drug?
   No prominent recent trials target new indications; current focus remains on established ophthalmic infections and inflammation.

3. How does antibiotic resistance impact the use of this combination?
   Growing resistance concerns may restrict use to confirmed bacterial infections and encourage development of alternative agents.

4. What are the main competitors to neomycin/dexamethasone formulations?
   Alternative fixed-dose combinations like polymyxin B/trimethoprim/dexamethasone and other broad-spectrum antibiotics.

5. What is the outlook for this drug's market over the next decade?
   The market is expected to grow modestly, with opportunities arising from new formulations, geographic expansion, and strategic collaborations.

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References

[1] Smith, J. et al. (2021). Efficacy of neomycin-dexamethasone eye drops in bacterial conjunctivitis: A randomized trial. American Journal of Ophthalmology.
[2] Grand View Research. (2022). Ophthalmic Anti-Infectives Market Size, Share & Trends Analysis.