iVeena Receives FDA Orphan Drug Designation for IVMED-80 for the Treatment of Keratoconus

30 October 2017

iVeena announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for IVMED-80, for the treatment of keratoconus. Keratoconus is a degenerative disorder causing a cornea to become conical in shape that can seriously distort vision. This may lead to a corneal transplant. IVMED-80 is the first eye-drop, non-surgical, non-laser treatment for medical crosslinking of the cornea.

“Receiving orphan drug designation is an important regulatory milestone, and we are pleased that IVMED-80 for keratoconus has been granted this status,” said Gerald Simmons, CEO of iVeena Delivery Systems. “We are developing IVMED-80 to potentially offer advantages over the standard of care and our team is committed to advancing the clinical development program.”

The Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people in the United States. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval.