Levofloxacin Ocular Implant for Ocular Surgery

An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.

This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.

Inclusion Criteria:

• Diagnosis of cataract in the intent to treat eye
• Endothelial cell density in the study eye of at least 2000 cells per mm2

Exclusion Criteria:

• history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
• recent surgery in the study eye
• subjects receiving a glaucoma device in conjunction with cataract surgery
• subjects with a compromised posterior capsule during surgery
• corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
• sensitivity to fluoroquinolones