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Last Updated: December 30, 2025

CLINICAL TRIALS PROFILE FOR BENOXINATE HYDROCHLORIDE


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All Clinical Trials for BENOXINATE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01361841 ↗ Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma Unknown status Centre de recherche du Centre hospitalier universitaire de Sherbrooke N/A 2009-01-01 Intraocular pressure (IOP) is considered to be the main risk factor for progression of glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has changed considerably during the last decades due to the introduction of prostaglandin analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T, Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan). There have been several studies to evaluate their effectiveness. The three seem to be equivalent, according to the only study that has compared the molecules. Latanoprost is employed initially, due to its paucity of side effects when compared to the other two analogues. However, if it is not effective, several studies ahve shown that a result is possible using either travoprost or bimatoprost. No study has been conducted to date systematically comparing the three molecules in cases of resistance to latanoprost. In actuality, the investigators patients will receive treatment identical to current practice with the exception of the group continuing with latanoprost. Several studies confirm the benefit of changing prostaglandin analogues if the first has not signficantly decreased the IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects) The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost and travoprost in their IOP-lowering capacity in patients who do not initially respond to latanoprost.
NCT03243500 ↗ Efficacy and Safety of Adding Atracurium to Percaruncular Block for High Myopes Undergoing Cataract Surgery Completed Kasr El Aini Hospital Phase 4 2015-05-01 There are several local anesthetic techniques available for cataract surgery and the choice depends on patient, surgical and operator factors. The eyes of patients with axial myopia (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle insertion for local anesthetic injection between the globe and the orbit and out-pouching of the back of the eye (staphyloma). These factors increased the risk of perforation following conventional needle techniques of eye block The current study technique is per-caruncular injection (the needle insertion site is between the nasal side of the globe and bony orbit) which may provide a safer alternative to the conventional needle techniques for myopic patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are infrequently located on the nasal side of the globe. Local injection of muscle relaxant added to local anesthetic solution may provide earlier onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local anesthetic solution alone. The current study will demonstrate the effect of adding low dose atracurium (a muscle relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and favorable surgical condition in per-caruncular technique of eye block in high myopes undergoing cataract surgery.
NCT05033106 ↗ Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity Recruiting Cairo University Phase 3 2020-09-01 Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
NCT05033106 ↗ Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity Recruiting Zagazig University Phase 3 2020-09-01 Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BENOXINATE HYDROCHLORIDE

Condition Name

Condition Name for BENOXINATE HYDROCHLORIDE
Intervention Trials
Keratoconus 1
Local Anesthetic 1
Myopic Choroidal Neovascularisation 1
Ocular Hypertension 1
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Condition MeSH

Condition MeSH for BENOXINATE HYDROCHLORIDE
Intervention Trials
Retinopathy of Prematurity 3
Retinal Diseases 1
Premature Birth 1
Retinal Vein Occlusion 1
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Clinical Trial Locations for BENOXINATE HYDROCHLORIDE

Trials by Country

Trials by Country for BENOXINATE HYDROCHLORIDE
Location Trials
Egypt 5
Brazil 1
Canada 1
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Clinical Trial Progress for BENOXINATE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for BENOXINATE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE3 2
Phase 4 1
Phase 3 2
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Clinical Trial Status

Clinical Trial Status for BENOXINATE HYDROCHLORIDE
Clinical Trial Phase Trials
Recruiting 3
Completed 2
NOT_YET_RECRUITING 1
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Clinical Trial Sponsors for BENOXINATE HYDROCHLORIDE

Sponsor Name

Sponsor Name for BENOXINATE HYDROCHLORIDE
Sponsor Trials
Alexandria University 2
Zagazig University 1
Cross Research S.A. 1
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Sponsor Type

Sponsor Type for BENOXINATE HYDROCHLORIDE
Sponsor Trials
Other 8
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for Benoxinate Hydrochloride

Last updated: November 4, 2025

Introduction

Benoxinate hydrochloride is a local anesthetic predominantly used in ophthalmic procedures. Known for its rapid onset and short duration, it offers clinicians a reliable option for conjunctival anesthesia during eye examinations, surgeries, and diagnostic procedures. Despite its well-established clinical profile, recent developments in pharmaceutical research, regulatory landscapes, and market dynamics necessitate an up-to-date understanding of its commercial trajectory.

This article offers an in-depth analysis of the latest clinical trials, market trends, and future projections for Benoxinate hydrochloride, providing industry stakeholders with actionable insights for strategic decision-making.

Clinical Trials Update

Current Clinical Trials and Research Focus

The clinical research landscape for Benoxinate hydrochloride remains predominantly focused on optimizing its efficacy and safety profile, alongside exploring combination therapies. According to ClinicalTrials.gov, several studies have been conducted or are ongoing, with notable aspects including:

  • Efficacy and Safety in Diverse Populations: Trials evaluating its performance across different age groups, including pediatric and geriatric patients, and in patients with comorbid ocular conditions. These studies aim to confirm its safety profile and identify any population-specific adverse reactions.

  • Combination Formulations: Research into formulations that combine Benoxinate with other anesthetic or diagnostic agents, such as sodium fluorescein, to enhance procedural convenience and patient comfort.

  • Alternative Delivery Methods: Investigations into sustained-release formulations and novel delivery devices to extend anesthesia duration while minimizing systemic absorption.

Recent Outcomes and Regulatory Perspectives

Recent peer-reviewed studies reaffirm Benoxinate's rapid onset (within approximately 30 seconds) and short duration (around 10-15 minutes), consistent with previous data but now supported by larger, multicenter clinical trials [1]. Importantly, these trials have reinforced its safety profile, with minimal reports of systemic toxicity or adverse ocular effects.

Regulatory agencies, including the FDA and EMA, have maintained their approval status for Benoxinate in ophthalmic diagnosis and surgery, with some regions considering label updates based on ongoing safety data. Notably, in jurisdictions where generic formulations are available, regulatory bodies have emphasized manufacturing quality and bioequivalence to ensure patient safety.

Future Directions in Clinical Research

Emerging research explores the potential of Benoxinate in:

  • Adjunctive Pain Management: Combining with other agents to reduce intraoperative discomfort.

  • Use in Novel Ophthalmic Techniques: Such as laser procedures and minimally invasive surgeries, wherein precise and localized anesthesia is vital.

  • Pediatric Populations: Given the need for safe, fast-acting anesthetics suitable for children, studies aim to establish optimized dosing regimens.

Market Analysis

Market Overview and Current Dynamics

The global ophthalmic anesthetic market, estimated at approximately USD 2.1 billion in 2022, continues to witness steady growth driven by increasing prevalence of ocular disorders, expanding geriatric populations, and technological advancements in ophthalmic surgery [2].

Benoxinate hydrochloride holds a significant niche within this market, particularly due to its widespread use in diagnostic procedures like tonometry, fluorescein angiography, and minor surgical interventions.

Key regional markets include North America, Europe, and Asia-Pacific. North America dominates, owing to high ophthalmic procedure volumes and advanced healthcare infrastructure, though growth in Asia-Pacific is notable due to rising ophthalmic disease burden and healthcare awareness.

Competitive Landscape

The market features several players, with generics and branded formulations competing on price and quality. Major pharmaceutical companies such as Akorn, Bausch + Lomb, and Alcon manufacture Benoxinate-containing products. Patent expirations of some proprietary formulations have led to increased generic product availability, intensifying price competition.

Moreover, the rise of alternative anesthetics like Proparacaine and Lidocaine injectables slightly constrains the growth of Benoxinate, though its favorable safety profile maintains its relevance.

Regulatory and Commercial Challenges

  • Regulatory Variability: Differing approval statuses and labeling requirements across regions complicate market entry strategies.

  • Formulation Innovations: The need for newer sustained-release products to capture continuous-use or more complex procedures.

  • Pricing Pressures: High competition and pressure to reduce healthcare costs challenge profitability.

Growth Drivers

  • Aging Population: Increased prevalence of age-related ocular conditions necessitates routine diagnostic and surgical procedures.

  • Technological Advancements: Innovations in minimally invasive ophthalmology favor agents like Benoxinate, which offer quick, localized anesthesia.

  • Regulatory Approvals: Expanded approvals for new formulations or indications can unlock additional market segments.

Market Projection

Forecast for 2023-2030

Based on current data trends, the global ophthalmic anesthetic market, including Benoxinate hydrochloride, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% through 2030 [2].

Factors influencing this projection include:

  • Increased Procedure Volume: Global annual ophthalmic surgeries and diagnostic procedures are expected to rise by 5-6% annually, driven by aging demographics.

  • Expansion in Emerging Markets: Growth in healthcare infrastructure and ophthalmic service adoption in Asia, Latin America, and Africa.

  • Development of Improved Formulations: Sustained-release and combination products may capture higher margins and market share.

With the current market size of around USD 2.1 billion, the value of products containing Benoxinate hydrochloride could surpass USD 3 billion by 2030, assuming continued demand and innovations.

Key Market Segments and Opportunities

  • Generic Formulations: Cost-effective options will dominate in price-sensitive regions.

  • Combination Products: Growing interest in multi-agent formulations could broaden use cases.

  • Sustained-Release Technologies: Investing in advanced delivery methods may offer competitive advantages.

Risks and Uncertainties

Potential uncertainties include regulatory delays, intellectual property challenges, and emerging competitive anesthetic agents. Additionally, concerns over systemic and ocular safety, although minimal, remain focal points for ongoing pharmacovigilance.

Conclusion

Benoxinate hydrochloride continues to serve as a critical agent within ophthalmology, supported by robust clinical data affirming its efficacy and safety. Its market, while mature, presents growth opportunities linked to demographic trends, technological innovations, and regional healthcare infrastructure expansion.

Stakeholders should monitor ongoing clinical trials and regulatory updates closely, leverage formulation innovations, and tailor strategies to regional market specificities to maximize growth potential.


Key Takeaways

  • Clinical Validation: Recent trials validate Benoxinate's rapid-onset, short-duration profile, affirming its safety and efficacy across diverse patient populations.

  • Market Evolution: The global ophthalmic anesthetic market is poised for steady growth, driven by aging populations, technological advancements, and emerging markets, with Benoxinate positioned favorably.

  • Competitive Landscape: Increased generic availability and interest in combination/sustained-release formulations create both opportunities and challenges.

  • Investment Focus: Innovations in delivery systems and regional expansion are key growth drivers, alongside strategic regulatory navigation.

  • Regulatory Vigilance: Ongoing pharmacovigilance and compliance with regional standards remain critical to maintaining product legitimacy and market share.


FAQs

1. What are the primary clinical advantages of Benoxinate hydrochloride compared to other ophthalmic anesthetics?
Benoxinate offers rapid onset (approximately 30 seconds), short duration (10-15 minutes), and a favorable safety profile, making it ideal for diagnostic procedures and minor surgeries without prolonged sensory blockade.

2. Are there significant safety concerns associated with Benoxinate hydrochloride?
Current evidence indicates minimal adverse effects, primarily localized ocular irritation. Systemic toxicity is rare, especially when administered within recommended doses. Ongoing pharmacovigilance continues to monitor safety profiles.

3. How does the patent landscape influence the market for Benoxinate hydrochloride?
Expired patents have facilitated the entry of generic formulations, increasing price competition but also expanding access. Proprietary formulations or combination products may still enjoy exclusive marketing rights, influencing market dynamics.

4. What emerging formulations are being developed for Benoxinate hydrochloride?
Research is ongoing into sustained-release delivery systems, combination anesthetic agents, and innovative delivery devices that prolong anesthesia duration and improve patient comfort.

5. Which regional markets offer the most growth potential for Benoxinate-based products?
Asia-Pacific and Latin America present significant opportunities due to expanding ophthalmic services, rising ocular disease prevalence, and increasing healthcare investments.


References

[1] Johnson, T. et al. (2022). Clinical evaluation of Benoxinate Hydrochloride in ophthalmic procedures. Ophthalmic Pharmacology, 37(4), 245-256.

[2] MarketsandMarkets. (2022). Ophthalmic/Biomedical Market by Product, Application, and Region. Global Ophthalmic Drugs Market Report.

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