Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Besivance Treatment Group · 1 trial · 1 indication
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 Treatment Group | EXPERIMENTAL | Besivance™ ophthalmic suspension, 0.6% |
| Polytrim Treatment Group | ACTIVE_COMPARATOR | Polytrim ophthalmic solution |
| Name | Type | Description |
|---|---|---|
| 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: * Persons who have been diagnosed with congenital Nasolacrimal Duct Obstruction (NLDO) with infection by the Principal Investigator * Both males and females * Persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is defined as when the Principal Investiga...
Besivance is a small molecule drug developed by Bausch + Lomb Corporation for the treatment of bacterial conjunctivitis and congenital nasolacrimal duct obstruction. It is an ophthalmic suspension containing besifloxacin 0.6%.
Besivance is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of bacterial conjunctivitis and congenital nasolacrimal duct obstruction.
Besivance is in Phase 3 clinical development for bacterial conjunctivitis, with a completed Phase 3 trial. It is also being studied in a Phase 1 trial for congenital nasolacrimal duct obstruction. Besivance is investigational and not yet approved by the FDA.
Besivance has been studied in two completed clinical trials. NCT01175590 was a Phase 3, randomized, double-blind, placebo-controlled trial in 518 patients with bacterial conjunctivitis. NCT01431170 was a Phase 1 trial in 24 children with congenital nasolacrimal duct obstruction.
Besivance is the brand name for besifloxacin ophthalmic suspension 0.6%. The drug contains the active ingredient besifloxacin, which is a fluoroquinolone antibiotic used to treat bacterial infections of the eye.