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FDA grants orphan drug status to eye drop treatment for keratoconus

November 15, 2017 from Healio.com

The FDA granted orphan drug designation to IVMED-80, an eye drop used for cross-linking the cornea to treat keratoconus.

“Receiving orphan drug designation is an important regulatory milestone, and we are pleased that IVMED-80 for keratoconus has been granted this status,” Gerald Simmons, CEO of iVeena Delivery Systems, said in a press release from the company. “We are developing IVMED-80 to offer another option in the treatment of keratoconus. The prospect of treating keratoconus with only a daily eye drop is very attractive, and our team is committed to advancing the clinical development.”

IVMED-80 biomechanically strengthens the cornea through daily administration of an eye drop.

IVeena Delivery System said it will begin clinical development in 2018.