Product Dossier
Lotemax
Product Dossier for Lotemax (loteprednol etabonate, Bausch & Lomb). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Bausch & Lomb
- Active ingredient: loteprednol etabonate
- Therapeutic area: Ophthalmology
- Same area: EYLEA
- Same area: OCUFLOX
What it is
Lotemax is loteprednol etabonate 0.5% eye drop suspension.
Approved indications
— Treatment of post-operative inflammation following cataract surgery. — Treatment of steroid responsive inflammatory conditions of contact lens associated giant papillary conjunctivitis (GPC).
Key safety warnings
Nonclinical studies demonstrated limited systemic absorption and an acceptable safety profile.
Regulatory history
Lotemax was approved for registration on the Australian Register of Therapeutic Goods on 13 January 2014. The TGA concluded that the benefits of Lotemax for the approved indications outweighed the identified risks, following a comprehensive evaluation of quality, nonclinical, and clinical data. Initial quality concerns regarding GMP clearance were resolved, allowing for a positive recommendation.