Regenerative therapies for corneal blindness

Corneal blindness is one of the leading causes of vision loss. According to WHO world health organization, more than 40 million people suffer from corneal loss of function worldwide, and the number will increase to 60 million by 2020. The number of new cases are rising because infection is the number one cause of corneal scarring. Cornea is the clear eye tissue, first layer, exposing to outside environment. Its refractive clarity and correct shape are responsible for 75% of vision focusing power. Its role is also to protect eyes from infection and injuries. Corneal ulcers, vascularization and ocular trauma also contribute major parts of corneal dysfunction. Cornea scarring is the most common blindness in children due to vitamin A deficiency, viral, fungal and bacterial infections, resulting more than 1-3 million cases.

Every minute a child goes blind due to corneal dysfunction. Corneal transplant is the only effective treatment available to restore vision from corneal blindness. Although corneal transplant is the most common transplant, the gap between corneal demands and supplies remains largely unmet. For example, there are more than a million people suffer from corneal blindness in the United States, but only 50,000 corneal transplants performed per year. In Asia, the waiting-list for corneal transplants is reported as long as 5-years. The shortage of corneal donors is the rate-limiting step. Supplies of complete corneal cell therapy are urgently needed.

Alternative options to human donor cornea are currently based on biosynthetic cornea technologies. These biosynthetic cornea technologies can be made of human-like proteins such as collagens or biocompatible materials such as polyethylene glycol (PEG). However, these biosynthetic materials lack biofactors for critical healing, are biodegradable, and are not self-renewal because they do not mimic human system by containing relevant cell types to renew these proteins when needed, once installed into human system, therefore, their long-term endurance is limited.  Furthermore the biosynthetic cornea clarity function, which is its most important function, is not at par to human donor corneas.

Our solution

The Medeze Research & Development team has short, medium, and long-term strategies to develop novel therapies related to corneal damages, and corneal vision loss. Our strategies aim to capitalize on advanced stem cell sciences and nanotechnologies and to translate these advancement to products that restore and improve vision acuity.

Short term plan

In our short term plan, we will focus on products that would repair long-term corneal strength and improve clarity of cornea in patients who have problems with corneal opacity, corneal epithelial defects, chronic recurrent erosion of corneal epithelium. Our technologies extract relevant growth factors from your own stem cells, making you autologous serum instead of pharmaceutical tear substitutes. These solutions can significantly better your corneal healing and reduce the risk of complications from immune irritability. For weaknesses in corneal stroma,  our solutions address the problems of keratocyte recruitment into corneal stroma layer and prevent blood vessel growth into corneal surfaces. Keratocytes, live cells in corneal stroma, maintain long-term strength and clarity of the cornea by providing collagen fibrin in correct patterns. The arranged patterns, spacing, and size of collagen fibers and the amount of water in stroma are critical for corneal clarity. These are because cornea needs keratocytes to consistently replenish collagens and cross-link substrates in correct patterns to ensure corneal clarity. Secondly, corneal solutions must reject neovascularization as this is a major cause of corneal opacity.

Medium term plan

Having mimicked human collagen patterns that co-align with keratocytes from actual human cornea, the Medeze R&D team plans to nanofabricate (or weave) collagens together with keratocytes. In order to successfully transplant lab-grown human stromal cornea, the designed patterns need to achieve corneal strength and clarity similar to corneas from human donors. These lab-grown human stromal corneas potentially address 70% of corneal blindness cases in which damages occur at stromal layer of cornea abrasion.

Long term plan

Our Medeze R &D team aims to generate a complete autologous cornea solution that features not only clear and strong stromal cornea but also functional corneal endothelial cell sheath that matches your immune needs. Currently, this option is not available in the market. Importantly, 90% of human donor corneal grafts fail because corneal endothelials stop pumping water out of cornea, and that excessive water brings about corneal cloudiness. The supply of corneal endothelial cells stops by the age of two. Subsequent growth of corneal endothelial sheath is achieved by enlargement of cell sizes. Corneal endothelial damages upon diseased or traumatic conditions are not restored by the body. Dysfunctional corneal endothelium causes excessive fluids in corneal stroma; thus, bring about corneal opacity and blindness. By combining our designed autologous stromal cornea with 3D culture grown nano-activated autologous endothelial cell sheath, we offer a complete solution for autologous corneal replacement therapy. This autologous matching would lower the risks of complications and graft rejection.