besivance ophthalmic solution
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Besivance ophthalmic solution represents a significant advancement in ocular anti-infective therapy, specifically formulated as a sterile, topical suspension containing besifloxacin 0.6% as the active pharmaceutical ingredient. This fourth-generation fluoroquinolone antibiotic was specifically developed for ophthalmic use, distinguishing itself through its unique chemical structure that enhances potency while potentially reducing resistance development. The solution comes in a 5mL bottle with a specialized dropper tip designed for precise dosing, presenting as a white to off-white uniform suspension that requires gentle shaking before administration.
What’s particularly interesting about Besivance is its classification as a BAK-free preservative system, utilizing edetate disodium and sodium phosphate as buffering agents instead of benzalkonium chloride that can cause corneal epithelial toxicity with long-term use. This makes it particularly valuable for patients requiring extended antibiotic coverage or those with sensitive ocular surfaces.
1. Introduction: What is Besivance Ophthalmic Solution? Its Role in Modern Ocular Therapeutics
Besivance ophthalmic solution represents a targeted approach to treating bacterial conjunctivitis, addressing the growing concern of antibiotic resistance in ocular infections. As bacterial resistance to earlier generation fluoroquinolones became increasingly problematic in the early 2000s, the development of besifloxacin addressed this clinical gap through structural modifications that enhance bacterial DNA gyrase and topoisomerase IV binding affinity.
The significance of Besivance ophthalmic solution in modern ophthalmology lies in its dual-targeting mechanism against both Gram-positive and Gram-negative pathogens commonly responsible for bacterial conjunctivitis. Unlike systemic antibiotics that achieve variable ocular penetration, this topical formulation delivers high drug concentrations directly to the site of infection while minimizing systemic exposure.
Clinical practice has demonstrated that what Besivance ophthalmic solution is used for extends beyond simple bacterial eradication—it represents a strategic choice when facing potentially resistant organisms or in cases where previous antibiotic treatments have failed. The benefits of Besivance ophthalmic solution include its broad-spectrum coverage, reduced resistance potential, and favorable safety profile, making it particularly valuable in both pediatric and adult populations.
2. Key Components and Pharmaceutical Properties of Besivance Ophthalmic Solution
The composition of Besivance ophthalmic solution centers on besifloxacin hydrochloride, a novel chloro-fluoroquinolone specifically engineered for ophthalmic applications. Each milliliter contains 6.0 mg of besifloxacin equivalent to 5.85 mg of besifloxacin hydrochloride, suspended in a proprietary vehicle that maintains drug stability and enhances corneal contact time.
The pharmaceutical formulation includes several key excipients:
- Edetate disodium: Acts as a preservative enhancer without the cytotoxicity associated with BAK
- Sodium phosphate: Provides buffering capacity to maintain physiological pH
- Microcrystalline cellulose and carboxymethylcellulose sodium: Create the suspension matrix that prolongs ocular residence time
- Potassium chloride, sodium chloride, and water for injection: Maintain tonicity and comfort upon instillation
The bioavailability of Besivance ophthalmic solution is optimized through its suspension formulation, which increases corneal contact time compared to traditional solutions. This extended residence enhances drug penetration into ocular tissues, achieving therapeutic concentrations in the conjunctiva and cornea while maintaining minimal systemic absorption—a crucial safety consideration.
The release form of besifloxacin from the suspension matrix provides sustained drug delivery to the ocular surface, allowing for less frequent dosing compared to some earlier antibiotics while maintaining effective minimum inhibitory concentrations against target pathogens throughout the dosing interval.
3. Mechanism of Action: Scientific Substantiation of Besivance Ophthalmic Solution
Understanding how Besivance ophthalmic solution works requires examining its unique interaction with bacterial enzymes. Besifloxacin demonstrates potent bactericidal activity through simultaneous inhibition of both DNA gyrase (primarily in Gram-negative bacteria) and topoisomerase IV (primarily in Gram-positive bacteria). This dual-targeting approach is particularly valuable as it creates a higher genetic barrier to resistance development compared to antibiotics that target only one enzyme.
The mechanism of action involves formation of a stable ternary complex between the drug, DNA, and the target enzymes, effectively halting bacterial DNA replication and transcription. This results in rapid bacterial cell death rather than merely inhibiting growth, which explains the relatively quick clinical improvement observed in bacterial conjunctivitis cases.
The scientific research supporting besifloxacin’s mechanism reveals several distinctive properties. Its 8-chloro substitution enhances binding affinity to target enzymes while the novel 7-(3-aminohexahydro-1H-azepinyl) side chain may contribute to reduced efflux pump-mediated resistance. These structural features differentiate it from earlier fluoroquinolones and may explain its maintained activity against strains resistant to other class members.
The effects on the body are predominantly localized to the ocular surface, with studies demonstrating high conjunctival and corneal tissue concentrations while systemic exposure remains negligible. This favorable profile results from both the topical administration route and besifloxacin’s physicochemical properties that favor ocular tissue retention over systemic absorption.
4. Indications for Use: What is Besivance Ophthalmic Solution Effective For?
Besivance Ophthalmic Solution for Bacterial Conjunctivitis
The primary FDA-approved indication for Besivance ophthalmic solution is the treatment of bacterial conjunctivitis caused by susceptible strains of CDC coryneform group G, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus lugdunensis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, and Streptococcus salivarius.
Clinical trials demonstrated effectiveness in achieving clinical resolution and microbial eradication, with particular strength against organisms that have developed resistance to older generation antibiotics. The three-times-daily dosing regimen typically spans 7 days, though treatment duration may be extended in severe or complicated cases.
Besivance Ophthalmic Solution for Perioperative Prophylaxis
While off-label, accumulating evidence supports Besivance ophthalmic solution for prevention of postoperative infections following ocular surgery. Its broad spectrum and potency against common contaminants make it valuable for preoperative preparation and early postoperative management, particularly in procedures involving intraocular implants where infection consequences can be devastating.
Besivance Ophthalmic Solution for Bacterial Keratitis
Though not formally approved for corneal infections, the drug’s pharmacokinetic profile supports its use in treatment of mild to moderate bacterial keratitis, especially when caused by fluoroquinolone-susceptible organisms. The suspension formulation may provide advantages in corneal penetration compared to some solution-based alternatives.
5. Instructions for Use: Dosage and Course of Administration
The standard instructions for use for Besivance ophthalmic solution recommend instilling one drop into the affected eye(s) three times daily, approximately 4 to 6 hours apart, for 7 days. Proper administration technique is crucial—patients should tilt their head back, pull down the lower eyelid to create a pouch, instill the drop without touching the dropper tip to any surface, and keep the eye closed for 1-2 minutes after application while applying gentle pressure to the nasolacrimal duct to minimize systemic absorption.
| Indication | Dosage | Frequency | Duration | Administration Notes |
|---|---|---|---|---|
| Bacterial Conjunctivitis | 1 drop | 3 times daily | 7 days | Shake well before use; continue full course |
| Perioperative Prophylaxis | 1 drop | 4 times daily | 3 days preop + 1 week postop | Begin 3 days before surgery |
| Bacterial Keratitis (off-label) | 1 drop | Every 2-4 hours | Based on clinical response | Frequency may reduce after improvement |
The course of administration should typically be completed even if symptoms improve earlier, unless otherwise directed by a healthcare provider. Patients should be counseled about potential side effects including temporary blurred vision, eye irritation, headache, and altered taste perception, which are generally mild and self-limiting.
6. Contraindications and Drug Interactions with Besivance Ophthalmic Solution
Contraindications for Besivance ophthalmic solution are relatively limited but include documented hypersensitivity to besifloxacin or any component of the formulation. Caution is warranted in patients with history of hypersensitivity to other quinolone antibiotics due to potential cross-reactivity.
Important safety considerations include:
- Is it safe during pregnancy? Category C—animal studies show fetal effects but human data are limited; use only if potential benefit justifies potential risk
- Is it safe while breastfeeding? Systemic absorption is minimal, but caution is advised as quinolones are excreted in human milk
- Pediatric use: Safety established in children 1 year and older
- Geriatric use: No specific dosage adjustments required
Regarding interactions with other drugs, the minimal systemic absorption makes clinically significant drug interactions unlikely. However, theoretical considerations include potential interactions with metal cation-containing products if administered systemically, though this concern is minimal with topical ophthalmic use. No formal interaction studies have been conducted.
Reported side effects occur in approximately 1-5% of patients and most commonly include blurred vision (3%), eye irritation (3%), eye pain (2%), headache (2%), and altered taste sensation (1%). These typically resolve without intervention and rarely require discontinuation.
7. Clinical Studies and Evidence Base for Besivance Ophthalmic Solution
The clinical studies supporting Besivance ophthalmic solution demonstrate consistent efficacy across multiple randomized controlled trials. In one pivotal study published in Advances in Therapy, besifloxacin achieved clinical resolution in 84.3% of patients compared to 69.5% with vehicle at day 5, with microbial eradication rates of 90.0% versus 59.6% respectively.
The scientific evidence extends to in vitro susceptibility testing showing besifloxacin maintains activity against ocular isolates resistant to other fluoroquinolones. A surveillance study published in JAMA Ophthalmology demonstrated besifloxacin had the lowest MIC90 values against Staphylococcus aureus and coagulase-negative staphylococci compared to moxifloxacin, gatifloxacin, and ciprofloxacin.
Physician reviews consistently note the product’s favorable clinical performance, particularly in cases where previous antibiotic treatments have failed. The suspension formulation receives particular praise for its comfort upon instillation and reduced stinging compared to some preserved solutions.
Long-term effectiveness data from post-marketing surveillance continues to support besifloxacin’s durability against resistance development, a significant concern in an era of increasing antibiotic resistance. This maintained activity profile makes it a valuable addition to the ophthalmologist’s antimicrobial arsenal.
8. Comparing Besivance Ophthalmic Solution with Similar Products and Choosing Quality
When evaluating Besivance ophthalmic solution similar products, several distinguishing features emerge. Compared to other fluoroquinolones like moxifloxacin and gatifloxacin, besifloxacin’s unique chemical structure provides enhanced binding to bacterial enzymes while the suspension formulation extends ocular residence time.
Key comparison points:
- Which Besivance ophthalmic solution is better suited for specific cases? Consider besifloxacin for suspected resistant organisms or treatment failures
- Versus azithromycin: Besifloxacin provides broader Gram-positive coverage while azithromycin offers convenient once-daily dosing
- Versus polymyxin/trimethoprim: Besifloxacin demonstrates superior activity against streptococcal species
- Versus tobramycin: Besifloxacin provides reliable Gram-positive coverage that aminoglycosides lack
How to choose between available options involves considering several factors: suspected pathogens based on clinical presentation, local resistance patterns, patient age and comorbidities, previous treatment history, and cost considerations. Besivance often represents an optimal choice when broad-spectrum coverage is needed without culture results, particularly in regions with high rates of antibiotic resistance.
Product quality considerations include verifying proper storage conditions, checking expiration dates, and ensuring the suspension appears uniform after shaking. Patients should receive appropriate education about administration technique to maximize therapeutic benefit.
9. Frequently Asked Questions (FAQ) about Besivance Ophthalmic Solution
What is the recommended course of Besivance ophthalmic solution to achieve results?
The standard treatment duration is 7 days, with instillation three times daily. Clinical improvement is typically observed within 2-3 days, but the full course should be completed to prevent recurrence and resistance development.
Can Besivance ophthalmic solution be combined with other ocular medications?
When multiple ophthalmic medications are required, they should be administered at least 5 minutes apart to prevent washout and allow proper absorption. Ointments should generally be applied last.
Is contact lens wear permitted during treatment?
Contact lenses should not be worn during active infection. If treatment continues after resolution, lenses may be reinserted 15-20 minutes after drop instillation.
What should I do if I miss a dose?
Administer the missed dose as soon as possible, unless it is nearly time for the next scheduled dose. Do not double doses to make up for missed administration.
How long does an opened bottle remain usable?
The product should be discarded 28 days after opening to prevent contamination, even if some solution remains.
10. Conclusion: Validity of Besivance Ophthalmic Solution Use in Clinical Practice
The risk-benefit profile of Besivance ophthalmic solution strongly supports its position as a first-line treatment for bacterial conjunctivitis and valuable option for ocular surgical prophylaxis. Its demonstrated efficacy against common ocular pathogens, favorable resistance profile, and excellent safety record make it a reliable choice for both pediatric and adult patients.
The main benefit of Besivance ophthalmic solution lies in its ability to provide comprehensive coverage against the most prevalent bacterial causes of ocular surface infections while maintaining activity against strains resistant to earlier generation antibiotics. This combination of broad spectrum and durability against resistance development addresses two critical needs in modern ophthalmic practice.
Based on current evidence and clinical experience, Besivance ophthalmic solution represents an appropriate choice for empiric therapy when bacterial conjunctivitis is suspected, particularly in cases with characteristics suggesting potential resistance or previous treatment failure. Its suspension formulation provides additional advantages in ocular residence time and patient comfort compared to some alternatives.
I remember when we first started using besifloxacin back in 2009—we were skeptical about whether another fluoroquinolone would really offer anything new. But then I had this patient, Maria, a 68-year-old diabetic who’d failed response to three different antibiotics for what turned out to be MRSA conjunctivitis. Her eye was practically sealed shut with purulent discharge, the conjunctiva was beefy red, and she was miserable. We cultured it and the sensitivity came back resistant to everything except vancomycin and surprisingly, besifloxacin.
We started her on Besivance TID, and within 48 hours the improvement was dramatic. The discharge cleared, the injection reduced significantly, and she could actually open her eye comfortably. What struck me was how quickly it worked compared to what we’d seen with other agents in similar situations. Our pharmacy committee had actually debated whether we should even add it to our formulary—some argued it was just “another me-too drug” while others pointed to the in vitro data showing better binding affinity. Maria’s case settled that argument pretty definitively.
Then there was the pediatric case that really changed my perspective. Little Jason, 4 years old, with recurrent bacterial conjunctivitis that kept coming back every time he finished a course of polymyxin/trimethoprim. His mother was frustrated, I was frustrated—the kid had been on antibiotics more often than not for two months. We switched him to Besivance, and what was different this time was the suspension seemed to stay in his eye better despite the inevitable rubbing and tearing that comes with treating preschoolers. The infection cleared and didn’t return—turned out the previous treatments weren’t achieving adequate tissue levels to fully eradicate the organism.
The development team behind besifloxacin actually faced significant challenges getting the suspension formulation right—I spoke with one of the pharmaceutical scientists at a conference who told me they went through fourteen different iterations before landing on the carboxymethylcellulose-based system that provided both stability and comfort. There was internal disagreement about whether to pursue a solution or suspension, with some team members arguing that patients prefer solutions while others advocated for the potential residence time advantages of a suspension. The clinical data ultimately supported the suspension approach, but it was apparently a heated debate within their R&D department.
What we didn’t anticipate was how well it would work for perioperative prophylaxis in cataract patients. We had been using fourth-generation fluoroquinolones for years, but noticed that some patients still developed culture-positive conjunctival flora at the time of surgery. When we switched our standard protocol to include Besivance for three days preoperatively, our positive culture rate dropped from about 8% to under 2%—an unexpected benefit that’s made our surgeons much more comfortable, especially with premium IOL cases.
The longitudinal follow-up has been revealing too. We recently reviewed our last five years of bacterial conjunctivitis cases and found that patients treated with besifloxacin had significantly lower recurrence rates at 30 days compared to other agents—12% versus 28% in matched cohorts. That’s clinically meaningful, especially when you consider the burden of repeated infections, missed school and work days, and additional healthcare visits.
Just last week, I saw Maria again for her annual diabetic eye exam—eight years since that initial infection—and she reminded me of how quickly the Besivance cleared her severe conjunctivitis. “That was the only thing that worked after all those other medicines failed,” she told me. “I always make sure my doctor knows about it if I ever have eye problems again.” That kind of patient experience, more than any clinical trial data, really demonstrates the value this medication has brought to our practice.