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Label indication BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans* CDC coryneform group G Corynebacterium pseudodiphtheriticum* Corynebacterium striatum* Haemophilus influenzae Moraxella catarrhalis* Moraxella lacunata* Pseudomonas aeruginosa* Staphylococcus aureus Staphylococcus epidermidis… FDA label
Also known as Besifloxacin hydrochloride, Besifloxacin Ophthalmic Suspension 0.6%, Besifloxacin 0.6%, Besivance, BOL-303224-A, ISV-403, BOL-303224
Besifloxacin · 6 trials · 4 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
The absence (grade 0 on the ordinal scale) of ocular discharge and bulbar conjunctival injection
Absence (grade 0 on the ordinal scale) of all ocular bacterial species that were present at or above the threshold value for that species from the Cagle list at baseline.
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Bacterial species eradication of baseline bacterial infection
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% |
| ISV-403 | EXPERIMENTAL | 0.6% ISV-403 ophthalmic suspension |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of ISV-403 ophthalmic suspension |
| Besifloxacin | EXPERIMENTAL | 0.6% ophthalmic suspension |
| Moxifloxacin | ACTIVE_COMPARATOR | Vigamox (moxifloxacin ophthalmic solution, 0.5%) |
| Gatifloxacin | ACTIVE_COMPARATOR | Zymar (gatifloxacin ophthalmic solution, 0.3%) |
| BOL-303224-A | EXPERIMENTAL | Systemic exposure of BOL-303224-A following single and multiple topical doses |
| 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. |
| ISV-403 | DRUG | Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days. |
| Vehicle | DRUG | Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (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. |
| BOL-303224-A | DRUG | 1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6). |
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, including acute bacterial conjunctivitis. It has also been studied for use around cataract extraction, where its concentrations in the aqueous humor of the eye were assessed. It is formulated as an ophthalmic suspension for topical eye use.
Besifloxacin is developed and marketed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is the sponsor behind the clinical development program for the drug, including the trials evaluating its use in bacterial conjunctivitis and in cataract extraction.
Besifloxacin has completed Phase 3 clinical development. A Phase 3 trial, NCT00348348, evaluated the safety and efficacy of the drug in acute bacterial conjunctivitis and enrolled 1,161 patients. Additional completed studies include a Phase 2 trial and a Phase 1 trial.
Besifloxacin has been studied in three completed trials. NCT00348348 was a Phase 3 trial in acute bacterial conjunctivitis with 1,161 patients. NCT00972777 was a Phase 2 trial in bacterial conjunctivitis with 474 patients, and NCT00824070 was a Phase 1 trial measuring drug concentrations in the aqueous humor of 105 cataract extraction subjects.
Yes. Besifloxacin hydrochloride is the salt form of the drug, and Besifloxacin Ophthalmic Suspension 0.6% is the marketed ophthalmic formulation. These names refer to the same active agent, a small molecule antibiotic in the ophthalmology therapeutic area.
Besifloxacin is a small molecule antibiotic. It acts against the bacteria that cause conjunctivitis, which is why it is formulated as a topical ophthalmic suspension for eye infections. Its development program also assessed its penetration into the aqueous humor of the eye during cataract extraction procedures.