EGP-437 (Delivered by Iontophoresis System)

Non-infectious Anterior Uveitis

Anterior uveitis is an inflammation of the uveal tract (middle layer of the eye), which includes the iris (colored part of the eye) and adjacent tissue, known as the ciliary body. If untreated or insufficiently treated, it can lead to severe complications including the development of glaucoma, cataract or retinal edema, often resulting in permanent damage including loss of vision.

In most cases of anterior uveitis, there is no obvious underlying cause, as the condition can occur as a result of a variety of factors including trauma to the eye, complications of other ocular conditions or autoimmune disease. Anterior uveitis often occurs for no apparent reason as the result of the immune system malfunctioning and triggering the process of inflammation even though no infection is present. Such inflammation without an infection is known as non-infectious anterior uveitis.

Signs/symptoms may include redness, soreness and inflammation of the eye, blurring of vision, sensitivity to light and a small pupil.

An estimated 17.6% of active uveitis patients experience transient or permanent vision loss on an annual basis. Uveitis is responsible for more than 2.8% of cases of blindness in the U.S., making it an important cause of vision loss and impairment. Incidence in the U.S. ranges from approximately 26.6 – 102 per 100,000 adults annually. While it occurs in all age groups, the highest incidence of the disease is in those over age 65.

For additional information on our clinical study of EGP-437 to treat non-infectious anterior uveitis, please click here.

post-Cataract Surgery Inflammation

Cataracts affect nearly 20.5 million Americans age 40 and older. By age 80, more than half of all Americans have cataracts. Cataract surgery has benefited from great technical advances but no consensus exists as regards optimal perioperative medical management of inflammation and infection prophylaxis. Generally, surgeons use an antibiotic regimen devised to minimize endophthalmitis and corticosteroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) to manage post-operative inflammation.

Currently patients are given a topical corticosteroid to instill as frequently as four times a day for up to four weeks after surgery. Effectively managing post-operative inflammation is regarded as an essential element of an optimal outcome. Currently the only way to be certain of this is by prescribing a corticosteroid and discussing with the patient and any care-giver the importance of complying fastidiously with the dosing schedule. Low patient compliance with eye drop regimes is well known. Consequently an essential part of the recovery process is left solely in the hands of the patient or care-giver.

Dexamethasone is recognized as a potent corticosteroid that can effectively manage inflammation.The delivery of dexamethasone into the eye by iontophoresis post-surgery may control post-operative inflammation in a manner that could eliminate the need for the use of postoperative anti-inflammatory eye drops. By doing so, the risk of inferior outcomes due to non-compliance can be avoided. The hypothesis is that by ensuring delivery of a potent corticosteroid into ocular tissues by iontophoresis post-surgery may better control post-operative inflammation, and the patient and care-giver will be relieved of the need to frequently instill eyedrops. Furthermore, it is possible that fewer corticosteroid related side effects will be seen (as observed in other clinical studies with EGP-437).

Macular Edema

Macular edema is an abnormal thickening of the macula, a thin layer of tissue that lines the posterior of the eye. It is associated with the leaking of fluid from retinal blood vessels. This excess fluid accumulates in the extracellular space of the retina, which leads to the thickening of the macula.

There are a wide variety of underlying causes of macular edema, such as diabetes, eye surgery, uveitis and retinal vein occlusion.

The pathological processes leading to macular edema involve numerous inflammatory cells, cytokines, growth factors, and intercellular adhesion molecules, which are associated with increased vascular permeability, breakdown of the blood-retinal barrier, remodeling of the extracellular matrix, and up-regulation of proangiogenic factors

As a final common pathway in numerous prevalent retinal disorders, macular edema in its various forms can be considered the leading cause of central vision loss in the developed world. As such, it is of significant importance both medically and socioeconomically.

For additional information on our clinical study of EGP-437 to treat macular edema, please click here.