Safety of repeated topical ocular administration of a polycarbophil-based formulation in several models of ocular surgery in rabbits

Krenzer, Kathleen L.; Zhang, Jinzhong; Coffey, Martin J.; Richardson, Mary

doi:10.1016/j.jcrs.2011.10.040

Cited by 11 publications

(10 citation statements)

References 26 publications

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“…Outcomes were remarkably similar to those observed with moxifloxacin ophthalmic solution 0.5%, a non-DuraSite formulation. These results are also consistent with a previous preclinical study by Krenzer et al who examined the effects of topical administration of the DuraSite vehicle using two dosing schedules on surgically compromised rabbit eyes, including those with laser-assisted in situ keratomileusis (LASIK) flaps or a 3 mm clear corneal incision 40. In the first dosing schedule, one drop of DuraSite (50 μL) was instilled immediately after surgery, with the second dose instilled later in the day, followed by four times daily for 14 days.…”

Section: Discussionsupporting

confidence: 90%

“…Histopathology examination did not indicate any unique safety concerns associated with the use of the DuraSite vehicle in these settings. 40 Taken together, these studies suggest that in routine, uncomplicated postoperative conditions, the use of Besivance for postoperative antibacterial prophylaxis does not appear to present safety concerns.…”

Section: Discussionmentioning

confidence: 84%

“…Furthermore, the mucoadhesive polycarbophil used in DuraSite has a very high molecular weight (in billions). Therefore, there is little possibility of the polymer gaining entry into the anterior chamber in the presence of a clear corneal incision created for cataract surgery 40. Furthermore, a surgical wound that is severely compromised is more likely to be associated with vision-threatening complications (eg, infection, endophthalmitis, hypotony, choroidal effusion) than any possible toxicity from the drug vehicle.…”

Section: Discussionmentioning

confidence: 99%

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Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Malhotra¹,

Gira²,

Berdy³

et al. 2012

OPTH

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BackgroundThe purpose of this study was to evaluate the safety and tolerability of besifloxacin ophthalmic suspension 0.6% compared with moxifloxacin ophthalmic solution 0.5%, when used for infection prophylaxis following uncomplicated phacoemulsification clear cornea surgery using sutureless corneal incision.MethodsThis prospective, two-site, parallel-group, investigator-masked clinical study included patients aged ≥18 years scheduled to undergo phacoemulsification with intraocular lens implantation. Patients received one drop of either besifloxacin ophthalmic suspension or moxifloxacin ophthalmic solution four times daily, beginning 3 days prior to surgery, which was continued for 7 days postoperatively. The primary endpoint was the rate of adverse events. Secondary endpoints included endothelial cell count, central corneal thickness, and overall and central corneal staining measured on days 7 (±1 day) and 28 (±2 days) following surgery, and intraocular pressure and best-corrected visual acuity measured on days 1, 7 (±1 day), and 28 (±2 days) following surgery.ResultsOf the 60 patients enrolled, 58 (29 per treatment group) completed the study. No adverse events were reported in either treatment group. Changes in the central corneal thickness, endothelial cell count, and corneal staining were small and similar between treatments at follow-up visits (P ≥ 0.1549). Intraocular pressure was similar between treatment groups at each visit, as was the distribution of best-corrected visual acuity. The final best-corrected visual acuity was 20/30 or better in 85% of the patients.ConclusionIn this study, besifloxacin ophthalmic suspension 0.6% was well tolerated when used prophylactically to prevent postoperative endophthalmitis following sutureless cataract surgery.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 99%

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Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Malhotra¹,

Gira²,

Berdy³

et al. 2012

OPTH

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“…In addition, Zhang et al39 demonstrated a lack of effect of besifloxacin ophthalmic suspension on corneal reepithelialization in rabbits with full-thickness corneal epithelial defects. Perhaps more relevant, it has been suggested that carbomer-based lubricants (eg, Viscotears [Alcon], Celluvisc [Allergan]) may help prevent flap dislocation, due to their shear thinning properties 40. Finally, in both treatment groups, a final VA of 20/20 or better was observed in >70% of cases, suggesting that visual rehabilitation was not affected by the choice of the topical antibiotic.…”

Section: Discussionmentioning

confidence: 99%

“…The safety of the DuraSite vehicle itself was studied in animal models of ocular surgery by Krenzer and colleagues 40. Krenzer et al studied the effect of topical administration of the DuraSite vehicle on surgically compromised rabbit eyes including eyes with a 3.0 mm clear corneal incision and eyes with a LASIK flap 40. Eyes were dosed with one drop of DuraSite (50 μL) QID for 1 day prior to surgery; 0.25 hours prior to surgery; 0.125, 4, and 8 hours after surgery; and then QID for an additional 9 days.…”

Section: Discussionmentioning

confidence: 99%

Safety of besifloxacin ophthalmic suspension 0.6% in refractive surgery: a retrospective chart review of post-LASIK patients

Clark¹,

Nielsen²,

McDonald³

et al. 2013

OPTH

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BackgroundTo evaluate the safety of besifloxacin ophthalmic suspension 0.6% when used in laser-assisted in situ keratomileusis (LASIK) prophylactic antibiotic regimens.MethodsRetrospective surveillance of LASIK surgery cases where besifloxacin ophthalmic suspension 0.6% or moxifloxacin ophthalmic solution 0.5% were prescribed as prophylactic medications. Surgeons from nine US surgical centers provided retrospective case information on surgical outcomes from consecutive cases and reported any adverse events related to the antibacterial used. The primary endpoint was the incidence of adverse drug reactions.ResultsA total of 801 case reports (801 eyes; 534 besifloxacin, 267 moxifloxacin) were obtained. The mean (standard deviation [SD]) age at time of surgery was 36.1 (10.6) years. The mean (SD) duration of antibiotic treatment was 8.6 (2.2) days in the besifloxacin group and 8.0 (2.3) in the moxifloxacin group; daily dosing frequency was higher in the moxifloxacin group preoperatively, on the day of surgery, and postoperatively. There were no reports of adverse drug reactions for the 801 eyes in this surveillance. There were no differences between the besifloxacin and moxifloxacin treatment groups in rates of unexpected corneal findings (2.1% vs 1.5%, P = 0.949). The distribution of final visual acuity for the besifloxacin and moxifloxacin groups were similar (P = 0.793). Most cases had a final visual acuity of 20/20 or better.ConclusionIn this retrospective surveillance study, the prophylactic use of besifloxacin ophthalmic suspension 0.6% and moxifloxacin ophthalmic solution 0.5% in patients undergoing LASIK surgery was not associated with any adverse drug reactions.

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Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections

Mah

Sanfilippo²

2016

Ophthalmol Ther

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This comprehensive review summarizes the mechanism of action, pharmacokinetics, efficacy, and safety of besifloxacin ophthalmic suspension, 0.6% and examines its role in the treatment of ocular surface bacterial infections. Besifloxacin possesses balanced activity against bacterial topoisomerase II (also called DNA gyrase) and topoisomerase IV. It has shown a low potential to select for bacterial resistance in vitro and demonstrated strong in vitro activity against many Gram-positive, Gram-negative, and anaerobic organisms, including methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis (MRSA and MRSE, respectively). Ocular pharmacokinetic studies have shown that besifloxacin achieves high, sustained concentrations in the tear fluid and conjunctiva following topical administration, with negligible systemic exposure. Large randomized, controlled clinical trials have established the efficacy and safety of besifloxacin administered three times daily for 5 days for treatment of acute bacterial conjunctivitis in both adults and children, with high rates of clinical resolution (up to more than 70% by day 5) and bacterial eradication (more than 90% by day 5), and a low incidence of adverse events. Additionally, besifloxacin applied twice daily for 3 days demonstrated greater efficacy than vehicle in treating bacterial conjunctivitis. Case reports, a large retrospective chart review, and animal studies have provided supporting evidence for the efficacy of besifloxacin in the management of acute bacterial keratitis. There is some evidence to suggest that besifloxacin may provide an advantage over other current-generation fluoroquinolones in antimicrobial prophylaxis for ocular surgery. Besifloxacin is an appropriate option for treatment of bacterial conjunctivitis, and its use in the treatment of bacterial keratitis and lid disorders, as well as for surgical prophylaxis, appears promising and warrants further evaluation.

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Safety of repeated topical ocular administration of a polycarbophil-based formulation in several models of ocular surgery in rabbits

Abstract: Results suggest that the polycarbophil-based formulation, like other shear-thinning formulations, is safe to use in topical ophthalmic pharmaceutical products indicated for chronic use and for treatment of conditions with compromise of the ocular surface.

Cited by 11 publications

References 26 publications

Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study

Safety of besifloxacin ophthalmic suspension 0.6% in refractive surgery: a retrospective chart review of post-LASIK patients

Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections

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