SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems (iVeena), a biopharmaceutical company that develops innovative ophthalmology products, today 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 progressively thin and become conical in shape. This can seriously distort vision and 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 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 is the first eye-drop, non-surgical, non-laser treatment for medical crosslinking of the cornea. IVMED-80 biomechanically strengthens the cornea through the daily application of a non-invasive, proprietary eye-drop. It has been granted Orphan Drug Designation by the FDA and will begin clinical development early 2018.
About iVeena Delivery Systems, Inc.
iVeena Delivery Systems, Inc. (iVeena) is a privately held biopharmaceutical company that develops innovative ophthalmology products. iVeena utilizes a proprietary intracapsular drug delivery platform to enhance a medication’s ocular bioavailability to anterior and posterior eye segments. The lead product delivers dexamethasone to treat post-cataract pain and inflammation as well as enable the prevention of retinal thickening associated with cataract extraction. The Company was formed to commercialize technology from the Moran Eye Center at the University of Utah. The Company is structured to develop product candidates through clinical trials and then out-license to pharmaceutical marketing partners. Currently, iVeena has completed a pilot clinical trial of its lead product (IVMED-10) and is preparing two additional products for clinical trials in Q1 2018 including keratoconus (IVMED-80) and prophylaxis of retinal thickening associated with cataract extraction (IVMED-20).