NDAOPHTHALMICSUSPENSION/DROPS
Approved
May 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
8
Mechanism of Action
[see Microbiology ( )] .
Pharmacologic Class:
Quinolone Antimicrobial
Indications (17)
bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans*CDC coryneform group GCorynebacterium pseudodiphtheriticum*Corynebacterium striatum*Haemophilus influenzaeMoraxella catarrhalis*Moraxella lacunata*Pseudomonas aeruginosa*Staphylococcus aureusStaphylococcus epidermidisStaphylococcus hominis*Staphylococcus lugdunensis*Staphylococcus warneri*Streptococcus mitis groupStreptococcus oralisStreptococcus pneumoniaeStreptococcus salivarius* *Efficacy for this organism was studied in fewer than 10 infections
Clinical Trials (5)
Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
Started Feb 2013
136 enrolled
Bacterial Conjunctivitis
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Started Sep 2011
24 enrolled
Congenital Nasolacrimal Duct Obstruction
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Started May 2011
33 enrolled
Bacterial Conjunctivitis
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
Started Sep 2010
60 enrolled
Corneal HealthCataract Surgery
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Started Jun 2010
518 enrolled
Bacterial Conjunctivitis
Loss of Exclusivity
LOE Date
Jan 9, 2031
59 months away
Patent Expiry
Jan 9, 2031