Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 Besivance
Besivance Treatment Group · 2 trials · 2 indications
Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events on the Study Eye
The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4: * 0: No tearing and discharge. * 1: Tearing, moderate mucous discharge around nasolacrimal punctum * 2: Moderate redness of the medial eyelid with mucous discharge * 3: Redness and swelling of the eyelid with mucopurulent discharge * 4: Redness and swelling of eyelid with purulent discharge Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following: Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit. Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade \>0 after a grade of 0 at the prior visit. Treatment Failure: grade is worse than or same as the baseline visit.
| Arm | Type | Description |
|---|---|---|
| Besivance | EXPERIMENTAL | besifloxacin ophthalmic suspension 0.6% |
| Vehicle | PLACEBO_COMPARATOR | Vehicle of Besivance |
| Besivance Treatment Group | EXPERIMENTAL | Besivance™ ophthalmic suspension, 0.6% |
| Polytrim Treatment Group | ACTIVE_COMPARATOR | Polytrim ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| Besivance | DRUG | Ocular administration to affected eye for 7 days |
| Vehicle | DRUG | Vehicle of Besivance administered to affected eye for 7 days |
| Besivance Treatment Group | DRUG | Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. |
| Polytrim Treatment Group | DRUG | Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days. |
Inclusion Criteria: * Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. * Subjects who are willing to discontinue contact lens wear for the duration of the study. * Subjec...
Besivance is an ophthalmic treatment studied for bacterial conjunctivitis and congenital nasolacrimal duct obstruction. It is a small molecule anti-infective developed by Bausch + Lomb Corporation (ticker BLCO). Clinical development has covered both pediatric and adult populations, including children as young as one month in the nasolacrimal duct obstruction study.
Besivance is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company sponsored the clinical program evaluating the therapy in bacterial conjunctivitis and congenital nasolacrimal duct obstruction, including the Phase 3 vehicle-controlled safety study and the pediatric Phase 1 study.
Besivance has been evaluated in Phase 3 clinical development. The Phase 3 study NCT01175590 compared Besivance 0.6% ophthalmic suspension to vehicle in 518 patients with bacterial conjunctivitis, and a Phase 1 study, NCT01431170, enrolled 24 children with congenital nasolacrimal duct obstruction. Both trials are completed.
Besivance has been studied in two completed trials. NCT01175590 was a Phase 3, randomized, double-blind, placebo-controlled safety study of Besivance 0.6% ophthalmic suspension versus vehicle in 518 patients with bacterial conjunctivitis. NCT01431170 was a Phase 1 safety and efficacy study in 24 children with congenital nasolacrimal duct obstruction, conducted in the United States.
Yes. Besivance is also known as Besivance, and the Phase 3 trial NCT01175590 refers to the study drug as Besivance (Besifloxacin Ophthalmic Suspension) 0.6%. The two names refer to the same ophthalmic anti-infective product developed by Bausch + Lomb Corporation for bacterial conjunctivitis.