A novel investigational compound that removes heavy metals intraocularly following topical administration is being studied for the treatment of cataract, band keratopathy, asteroid hyalosis, and IOL calcifications.
Los Gatos, CA-based Chakshu Research is developing the agent. The indications being explored include treatment of cataract, band keratopathy, asteroid hyalosis, and IOL calcifications. Based on its mechanism(s) of action, however, the agent may be expected to have several other potential applications.
"This compound appears to afford an innovative, nontoxic method to treat several different eye diseases. Demonstration of efficacy and safety will require much further study as clinical investigations are still in very early stages, but it is exciting that this new technology may be applied in a variety of other yet unexplored therapeutic areas," said Dr. Olson, the John A. Moran Presidential Professor and chair, Department of Ophthalmology and Visual Sciences, University of Utah, Salt Lake City.
"Heavy metals serve as an intracellular and extracellular catalyst for many inflammatory processes in the eye. Removing the metal with this compound inhibits those pathways," Dr. Olson explained.
So far, a host of preclinical studies have been undertaken to investigate the therapeutic potential of the investigational agent. This research has established favorable penetration to intraocular target tissues achieved following topical administration.
In vitro studies using a human lens epithelial cell line showed that treatment with the investigational agent significantly improved cell survival after exposure to a variety of oxidative stresses and to a level equivalent to unexposed controls. Results of an in vivo study performed in the Norway rat diabetic cataract model indicated the treatment could have a protective effect against glucose-induced cataract formation.
"It has also been shown to have activity for removing the multilamellar bodies that are the result of crystalline fiber degeneration and are thought responsible for light scatter in the opacified lens," Dr. Olson noted.
"The FDA study has just been unmasked, and the analyses are still under way, but preliminary information suggests that there was a clinically significant effect using one of the two doses investigated," Dr. Olson explained.