Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Besifloxacin · 3 trials · 3 indications
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
| Arm | Type | Description |
|---|---|---|
| Moxifloxacin solution | ACTIVE_COMPARATOR | Moxifloxacin hydrochloride ophthalmic solution 0.5% |
| Besifloxacin Suspension | EXPERIMENTAL | Besifloxacin hydrochloride ophthalmic suspension 0.6% |
| Besifloxacin | EXPERIMENTAL | 0.6% ophthalmic suspension |
| Vehicle | PLACEBO_COMPARATOR | - |
| Moxifloxacin | ACTIVE_COMPARATOR | Vigamox (moxifloxacin ophthalmic solution, 0.5%) |
| Gatifloxacin | ACTIVE_COMPARATOR | Zymar (gatifloxacin ophthalmic solution, 0.3%) |
| Name | Type | Description |
|---|---|---|
| Besifloxacin | DRUG | Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days |
| Moxifloxacin solution | DRUG | Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days. |
| Vehicle (Placebo) | DRUG | Vehicle administered to the study eye two times a day for three days. |
| Besifloxacin hydrochloride | DRUG | Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
| moxifloxacin hydrochloride | DRUG | Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
| gatifloxacin | DRUG | Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery. |
Inclusion Criteria: * Clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye. Exclusion Criteria: * Pregnant or nursing females. * Use of any antibiotic within 72 hours of enrollment. * Any disease conditions that could int...
Besifloxacin is an ophthalmic antibiotic used to treat bacterial conjunctivitis, commonly known as pink eye. It is also being studied in the context of cataract extraction surgery. The drug is delivered as an ophthalmic suspension and is intended for use in the eye to combat bacterial infections.
Besifloxacin is a fluoroquinolone antibiotic that works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication. This action leads to the death of susceptible bacteria, making it effective against a range of ocular pathogens responsible for bacterial conjunctivitis.
Besifloxacin is developed by Bausch + Lomb Corporation, a company publicly traded under the ticker symbol BLCO. Bausch + Lomb is a global eye health company that focuses on developing and commercializing products for various ophthalmic conditions, including infectious diseases of the eye.
Besifloxacin is in Phase 3 clinical development for the treatment of acute bacterial conjunctivitis. A Phase 3 trial, NCT00348348, has been completed, evaluating the safety and efficacy of the drug in 1,161 patients. The drug is investigational and has not yet received FDA approval.
Besifloxacin has been studied in several clinical trials. A completed Phase 3 trial (NCT00348348) evaluated its efficacy in acute bacterial conjunctivitis with 1,161 participants. Other completed trials include a Phase 1 study (NCT00824070) on aqueous humor concentrations during cataract extraction, a Phase 2 trial (NCT00972777) for bacterial conjunctivitis, and a Phase 1 study (NCT01120418) on corneal endothelial cell density in healthy subjects.
Yes, Besifloxacin is also known as BOL-303224. In clinical trials, the drug has been referred to by this alternative name, as seen in the Phase 3 study titled 'A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis.'