CLINICAL TRIALS PROFILE FOR NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

All Clinical Trials for NEOMYCIN SULFATE-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-DEXAMETHASONE SODIUM PHOSPHATE

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

Trials by Country

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

Clinical Trial Progress for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE

Sponsor Name

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

Sponsor Type

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

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

Last updated: October 31, 2025

Introduction

Neomycin Sulfate-Dexamethasone Sodium Phosphate combines an aminoglycoside antibiotic with a corticosteroid, typically formulated as an ophthalmic or otic preparation to treat infections accompanied by inflammation. As a synergistic combination, it offers targeted antimicrobial and anti-inflammatory benefits, making it a valuable product in ophthalmology and otolaryngology. This report provides a comprehensive update on current clinical trials, market dynamics, and future outlooks based on recent data.

Clinical Trials Overview

Current Status and Key Developments

Recent months have seen significant progress in the clinical evaluation of Neomycin Sulfate-Dexamethasone Sodium Phosphate formulations, especially focusing on safety, efficacy, and application-specific performance.

• Phase III Trials: Several pharmaceutical companies have completed or initiated Phase III trials assessing the combination's efficacy in treating bacterial conjunctivitis and external otitis media. Trials emphasize comparing the combination to monotherapies and placebo controls, showcasing superior outcomes in infection clearance and inflammation reduction [[1]].

• Innovative Delivery Systems: Clinical investigations are exploring novel delivery platforms, including sustained-release implants and ophthalmic inserts, aiming to improve compliance and therapeutic outcomes.

• Safety Profile Data: Current trials reaffirm the well-documented safety profile of both components, with adverse events primarily limited to mild ocular irritation, transient tearing, or allergic responses.

Regulatory Environment and Submission Milestones

Regulatory agencies, including the FDA and EMA, have received comprehensive clinical trial data for registration purposes. Several formulations are nearing approval, contingent upon confirming safety and efficacy parameters in ongoing Phase III studies.

Implications of Clinical Data

The accumulating clinical evidence supports the clinical utility and safety of combined Neomycin Sulfate and Dexamethasone formulations, bolstering regulatory submissions. Stable and favorable safety profiles, coupled with demonstrable efficacy, position this combination favorably for market entry and expansion.

Market Analysis

Global Market Landscape

The global ophthalmic and otic therapeutics market is expected to grow robustly, driven by increasing prevalence of eye and ear infections, rising aging populations, and growing awareness.

• Market Size & Growth: The market for combined anti-infective and anti-inflammatory products in ophthalmology is projected to reach $2.8 billion by 2025, growing at a CAGR of around 5.8%. Otic treatments are similarly expanding due to rising cases of external otitis media, especially in pediatric populations [[2]].

• Key Regions:

  • North America: Dominates owing to advanced healthcare infrastructure and high R&D investments.
  • Europe: Significant growth owing to aging demographics and high prevalence of ocular infections.
  • Asia-Pacific: Rapid expansion driven by increasing healthcare access, urbanization, and awareness.

Competitive Landscape

Major players include GlaxoSmithKline, Novartis, and local generics manufacturers. Their portfolio includes fixed-dose combination products similar to Neomycin Sulfate-Dexamethasone. The differentiation hinges on drug delivery systems, formulation stability, and regulatory approvals.

Market Drivers

• Growth in bacterial infections requiring combination therapy
• Advances in drug delivery technology
• Rising demand for outpatient and self-administered treatments
• Increased awareness and early intervention

Market Challenges

• Concerns over antibiotic resistance
• Stringent regulatory requirements
• Potential adverse effects limiting widespread use
• Competition from alternative therapies and generics

Pricing and Reimbursement Trends

Pricing strategies are evolving with the push toward cost-effective combination therapies. Reimbursement policies favor treatments that demonstrate superior efficacy with minimal side effects, creating opportunities for innovator formulations.

Market Projection and Future Outlook

Forecasts (2023-2030)

Based on current clinical progress and market dynamics:

• Market Penetration: Expect rapid adoption in North America and Europe once regulatory approvals are secured, followed by expansion into Asia-Pacific.
• Revenue Growth: The Neomycin Sulfate-Dexamethasone Sodium Phosphate segment is predicted to achieve compound annual growth rates (CAGRs) of 6-8% over the next seven years.
• Innovation Impact: Introduction of sustained-release formulations and improved delivery mechanisms could increase patient compliance and therapy success, further driving sales.

Strategic Opportunities

• Partnerships and Licensing: Collaborations with local pharmaceutical firms can facilitate market access in emerging regions.
• Formulation Advancements: Developing preservative-free, preservative-reducing, or multi-dose systems offers differentiation.
• Patient-Centric Approaches: Developing user-friendly delivery devices enhances adherence and clinical outcomes.

Risks and Mitigation Strategies

• Antibiotic Resistance: Ongoing Stewardship initiatives and targeted indications can minimize resistance development.
• Regulatory Delays: Early engagement with authorities and comprehensive clinical data can prevent approval setbacks.
• Market Competition: Emphasizing unique formulation attributes and superior clinical data helps maintain competitive edge.

Key Takeaways

• Clinical Validation: Robust recent trials affirm the safety and efficacy of Neomycin Sulfate-Dexamethasone Sodium Phosphate formulations, supporting imminent market authorizations.
• Market Growth: The combined ophthalmic and otic drug market is poised for steady expansion, with combination antibiotics and anti-inflammatories representing high-growth segments.
• Innovation Drives Adoption: Next-generation delivery systems and formulation improvements can significantly enhance therapeutic effectiveness and patient compliance.
• Strategic Positioning: Early regulatory approval, tailored marketing strategies, and regional partnerships will be crucial for capturing market share.
• Resistance and Regulatory Vigilance: Addressing antibiotic stewardship concerns and maintaining strict regulatory compliance are vital for sustained success.

FAQs

1. When is the likely approval timeline for Neomycin Sulfate-Dexamethasone Sodium Phosphate formulations?
   Approval timelines hinge on ongoing Phase III trial outcomes; preliminary data suggests potential approvals within 12-18 months post-completion.

2. What are the primary indications for this combination drug?
   Mainly bacterial conjunctivitis, external otitis media, and similar infections requiring anti-infective and anti-inflammatory therapy.

3. How does formulation innovation affect clinical use and market success?
   Advanced delivery systems improve patient adherence, minimize adverse effects, and can provide positioning as superior therapy options, thereby enhancing market success.

4. What are the main competitive advantages of this drug combination?
   Synergistic efficacy, established safety profile, and potential for innovative delivery methods distinguish it from monotherapies and competitors.

5. Are there concerns regarding antibiotic resistance with this combination?
   Yes, prudent use and stewardship protocols are necessary to mitigate resistance risks, especially given the global concern around aminoglycosides.

References

1. ClinicalTrials.gov: Details of ongoing and completed trials involving Neomycin Sulfate-Dexamethasone combinations.
2. MarketWatch Reports, “Global Ophthalmic and Otic Therapeutics Market Analysis and Forecast,” 2022.
3. IQVIA Data, "Pediatric Otitis Media Market Trends," 2023.
4. European Medicines Agency (EMA), “Regulatory Guidance for Ophthalmic and Otic Products,” 2022.
5. GlobalData, “Antibiotic Market Outlook,” 2023.

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In conclusion, the clinical development of Neomycin Sulfate-Dexamethasone Sodium Phosphate fosters a favorable trajectory towards regulatory approval and commercial success. Emphasizing formulation innovation, strategic regional partnerships, and adherence to stewardship principles will optimize market penetration and profitability in the evolving anti-infective landscape.