May 17, 2019 | Author: Admin
IVMED-80 (iVeena), which has received an orphan drug designation from the FDA. This drug has copper as an active ingredient, to enhance the activity of lysyl oxidase. Keratoconus occurs, Dr. Ambati explained, when there is a deficiency of natural crosslinks in the cornea, which is associated with lysyl oxidase mutations.
Donor tissue that had been treated with IVMED-80 showed better stress-strain curves, Dr. Ambati said. In vivo rabbit studies with IVMED-80 showed increased ysyl oxidase activity, which he noted as biomechanical evidence of increased crosslinking. There have been no toxic or adverse events. Currently, a Phase 1/2a clinical trial in Mexico is taking place with 36 keratoconus or post-LASIK ectasia patients who take two drops a day of either vehicle or IVMED-80. The primary end-point is reduction of kmax and kmean at 6 months with a secondary endpoint of biomechanical stiffness. At 1 month, 0.6 D of flattening seen at 1 year with the Dresden crosslinking protocol.
A pharmacologic method of flattening the cornea, Dr. Ambati and should, perhaps, take more of Dr. Ambati’s focus. From a financial/investment standpoint, Dr. Link said that this would be a relatively expensive project to do properly and the first quality investment would need to see detailed planning out to FDA approval.