Introduction
Fluorescein sodium and benoxinate hydrochloride ophthalmic solution is a combination product used for ophthalmic procedures, combining a disclosing agent (fluorescein sodium) with a local anesthetic (benoxinate hydrochloride). This article will delve into the clinical trials, market analysis, and projections for this drug.
Clinical Trials and Efficacy
Overview of Clinical Studies
Clinical trials and studies have demonstrated the efficacy and safety of fluorescein sodium and benoxinate hydrochloride ophthalmic solution. Controlled clinical studies in both adults and pediatric patients have shown that this solution provides adequate corneal anesthesia and visualization necessary for various ophthalmic procedures, including applanation tonometry, tear fluid dynamics evaluation, and short conjunctival and corneal procedures[2][4].
Key Findings
- Anesthesia and Visualization: The solution achieves maximal corneal anesthesia within 5-45 seconds, which lasts approximately 20 minutes after a single administration[2].
- Safety Profile: No significant changes in the safety profile have been identified in recent updates, and the solution is well-tolerated in both adult and pediatric populations[1][2].
Specific Trials
While the specific trials focused on fluorescein sodium and benoxinate hydrochloride are limited in the public domain, related studies and comparisons with other ophthalmic solutions provide valuable insights. For instance, a study comparing the potential for bacterial contamination of different ophthalmic solutions highlighted the antimicrobial properties of the fluorescein-benoxinate hydrochloride combination, showing rapid elimination of bacterial contaminants[4].
Market Analysis
Current Market Status
The fluorescein sodium and benoxinate hydrochloride ophthalmic solution is approved and widely used in the United States and other countries. It is marketed by several companies, including Bausch + Lomb, under various brand names such as Fluress® and Altafluor[5].
Market Size and Growth
The ophthalmic market, particularly the segment involving diagnostic and anesthetic solutions, is expected to grow. While specific figures for this combination product are not readily available, the broader ophthalmic market trends indicate a positive outlook. For example, the uveitis market, which is part of the larger ophthalmic therapeutic area, is projected to grow significantly, reaching nearly $550 million in the United States and over $1 billion globally by 2024[3].
Competitive Landscape
The market for ophthalmic diagnostic and anesthetic solutions is competitive, with several products available. However, the combination of fluorescein sodium and benoxinate hydrochloride offers a unique advantage due to its dual action as both a disclosing agent and a local anesthetic. This combination makes it a preferred choice for many ophthalmic procedures[2][5].
Market Projections
Future Growth
Given the increasing demand for ophthalmic care and the expanding aging population, the market for fluorescein sodium and benoxinate hydrochloride is expected to grow. The solution's efficacy, safety profile, and convenience make it a staple in ophthalmic practices, contributing to its continued market presence and growth.
Emerging Trends
Emerging trends in ophthalmology, such as the integration of advanced diagnostic technologies and the need for more efficient and safe procedures, are likely to further boost the demand for this solution. The combination of a disclosing agent and an anesthetic addresses multiple needs in a single product, aligning well with the trend towards streamlined and efficient clinical practices.
Storage and Handling
Proper storage and handling are crucial for maintaining the efficacy and safety of the solution. It is recommended to store the solution refrigerated at 36° to 46° Fahrenheit. Once opened, the bottle can be stored at room temperature for up to one month or refrigerated until the expiration date[5].
Adverse Reactions and Contraindications
While generally well-tolerated, the solution can cause adverse reactions such as ocular hyperemia, burning, stinging, eye irritation, blurred vision, and punctate keratitis. It is contraindicated in patients with known hypersensitivity to any component of the product[2].
Use in Specific Populations
Pediatric Use
The safety and effectiveness of fluorescein sodium and benoxinate hydrochloride ophthalmic solution have been established in pediatric patients through adequate and well-controlled studies[2].
Lactation
There are no data on the presence of fluorescein sodium or benoxinate hydrochloride in human milk after ocular administration. However, the benefits of breastfeeding should be weighed against the mother’s clinical need for the solution and any potential adverse effects on the breastfed infant[2].
Key Takeaways
- Clinical Efficacy: The solution is effective for providing corneal anesthesia and visualization in ophthalmic procedures.
- Market Growth: The market for this solution is expected to grow due to increasing demand for ophthalmic care.
- Safety Profile: Generally well-tolerated, but can cause adverse reactions such as ocular hyperemia and stinging.
- Storage: Requires refrigeration and proper handling to maintain efficacy.
- Pediatric Use: Safe and effective for pediatric patients.
FAQs
Q: What is the primary use of fluorescein sodium and benoxinate hydrochloride ophthalmic solution?
A: The primary use is for ophthalmic procedures requiring a disclosing agent and a topical anesthetic in adult and pediatric patients.
Q: How quickly does the solution achieve maximal corneal anesthesia?
A: Maximal corneal anesthesia usually occurs within 5-45 seconds after administration.
Q: What are the common adverse reactions associated with this solution?
A: Common adverse reactions include ocular hyperemia, burning, stinging, eye irritation, blurred vision, and punctate keratitis.
Q: Is the solution safe for use in pediatric patients?
A: Yes, the safety and effectiveness of the solution have been established for pediatric patients through adequate and well-controlled studies.
Q: How should the solution be stored?
A: The solution should be stored refrigerated at 36° to 46° Fahrenheit. Once opened, it can be stored at room temperature for up to one month or refrigerated until the expiration date.
Sources
- FDA NDA Submission: "208582Orig1s000 - accessdata.fda.gov"
- DailyMed: "Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% - dailymed.nlm.nih.gov"
- Synapse Patsnap: "Bausch & Lomb, Inc. - Drug pipelines, Patents, Clinical trials - Synapse"
- Synapse Patsnap: "Benoxinate Hydrochloride/Fluorescein Sodium - Patsnap Synapse"
- Hilco Vision: "Fluorescein Sodium and Benoxinate - Hilco Vision"
