The corneal endothelium is composed of a single layer of cells located on the posterior surface of the cornea, facing the anterior chamber. The endothelium governs fluid and nutrient transport across the posterior surface of the cornea in a pump-and-barrier function and maintains the cornea in an optimized state required for optical transparency and optimal vision.
Corneal endothelial disease is a serious, sight-threatening and debilitating condition affecting millions of people throughout the world.
Unlike the epithelium, which has a self-renewing capacity, the endothelium is not capable of regenerating. Corneal endothelial dysfunction occurs when endothelial cells degrade and/or are lost due to conditions such as Fuchs’ dystrophy, congenital corneal dystrophies or ocular surgical trauma. Corneal endothelial dysfunction leads to blurred vision, increased glare, discomfort, and, in some cases, severe ocular pain.
Treatment of mild endothelial dysfunction may involve topical therapy to reduce corneal edema.
For more severe endothelial dysfunction, the most common and effective treatment is replacement of the diseased corneal endothelium via surgical corneal transplantation.1
Penetrating Keratoplasty (PK), or full-thickness corneal transplantation, was the early treatment of choice for endothelial failure. More recently, new partial-thickness corneal transplant techniques have been developed to enable more selective replacement of the diseased corneal endothelium. These approaches, termed Endothelial Keratoplasty (EK), are most appropriate for disease processes that exclusively or predominantly involve the corneal endothelium.
One form of EK is Descemet‘s Stripping (Automated) Endothelial Keratoplasty (DSEK or DSAEK), where the diseased host endothelium and associated Descemet’s membrane are removed from the central cornea, and in their place a harvested layer of healthy donor tissue is grafted. This layer consists of posterior stroma, Descemet’s membrane, and endothelium that has been dissected from donor corneal tissue. The other form of EK is Descemet’s Membrane Endothelial Keratoplasty (DMEK), in which the donor tissue consists only of Descemet’s membrane and corneal endothelium. Both of these EK procedures have proven effective and safe; however, they are limited by the supply of available donor corneal tissue.
Aurion Biotechnologies acquired rights to the original IP from its inventors, who are based in Japan, where clinical development of the product candidate had already begun.
At present, Aurion Biotechnologies is preparing an IND for submission to the US FDA. It has begun planning for clinical development in the EU.
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