Cornea/External Disease, Refractive Mgmt/Intervention

The FDA has granted orphan status to IVMED-80, a daily eye drop for keratoconus. The drop is the first non-surgical, non-laser treatment for medical crosslinking of the cornea.

Unlike corneal crosslinking (CXL), the drops biomechanically strengthen the cornea in a minimally invasive fashion.

“The prospect of treating keratoconus with only a daily eye drop is very attractive,” says Gerald Simmons, CEO of iVeena Delivery Systems, in a press release from the company. “Receiving orphan drug designation is an important regulatory milestone, and we are pleased that IVMED-80 for keratoconus has been granted this status.”

The FDA’s Orphan Drug Act provides a bundle of benefits intended to spur the development of treatments for rare diseases. These benefits may include tax credits to offset clinical trial expenses and market exclusivity for 7 years after approval.

Keratoconus, a gradual thinning of the cornea, affects an estimated 1 in 2,000 Americans per year. Some patients eventually require a corneal transplant.

IVeena Delivery System has announced plans to begin clinical development of the eye drop in early 2018.