Ista Submits Supplemental New Drug Application For XiDay

Ista has submitted a supplemental New Drug Application (sNDA) to the FDA for bromfenac ophthalmic solution as a treatment for ocular inflammation and pain following cataract surgery. Ista currently markets Xibrom (bromfenac ophthalmic solution) 0.09%, which is an eye drop labeled for use twice-daily, beginning 24 hours after cataract surgery.

If approved, Ista plans to market the once-daily product under the brand name – XiDay.

Ista filed the sNDA for XiDay electronically in eCTD format. Pending FDA validation of the electronic file in the coming days and timely acceptance of the filing by the FDA, Ista expects a standard review of six months from date of receipt.

Xibrom is a topical non-steroidal anti-inflammatory compound for the treatment of ocular inflammation and pain, following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals. Ista acquired US marketing rights for Xibrom in 2002 and launched the product in the US in 2005.

Xibrom currently is labeled as an eye drop used twice-daily beginning 24 hours after cataract surgery. Xibrom has not been approved by the FDA as a once-daily treatment. Ista’s sNDA filing requests the Agency to approve a change to bromfenac ophthalmic solution’s label to reflect its efficacy as a once-daily treatment in this patient population.