iVeena Delivery Systems announced that the FDA has granted orphan drug designation for IVMED-80, for the treatment of keratoconus. 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,” Gerald Simmons, CEO of iVeena Delivery Systems, said in a company news release. “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.”
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.
IVMED-80 has been granted Orphan Drug Designation by the FDA and will begin clinical development early 2018.