Product Dossier
BESIVANCE
Product Dossier for BESIVANCE (besifloxacin, Bausch & Lomb). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Bausch & Lomb
- Active ingredient: besifloxacin
- Therapeutic area: Ophthalmology
- Same area: EYLEA
- Same area: OCUFLOX
What it is
Besivance is a besifloxacin 0.6% w/v suspension eye drops formulation.
Approved indications
— Severe, confirmed bacterial conjunctivitis caused by besifloxacin sensitive bacteria. — Treatment in adults and children 12 months and older.
Regulatory history
Besivance (besifloxacin hydrochloride 0.6% ophthalmic suspension) was approved by the TGA for the treatment of severe, confirmed bacterial conjunctivitis after satisfactory resolution of pharmaceutical chemistry issues and positive nonclinical findings supporting its efficacy and safety profile. The product was first listed on the ARTG on 7 November 2013. All pharmaceutical chemistry issues were satisfactorily resolved, and nonclinical studies, including in vitro and in vivo efficacy, supported the product's antibacterial activity. Safety pharmacology findings, such as cardiovascular and renal effects, were noted but considered acceptable given low systemic exposure.