Mitotech eyes novel approach to treating Dry Eye Disease

An aging population, an ever increasing amount of time viewing digital devices and a growing trend in eye diseases are all factors expected to fuel a global increase in Dry Eye Disease. Currently, there are about 16 million people in the U.S. alone suffering from the condition, which is quickly becoming a common malady.

According to the research and consulting firm GlobalData, the global market for treating dry eye is expected to climb to an estimated $4.6 billion by 2024, more than doubling the estimated $2.2 billion market size of 2014.

Additionally, Dry Eye Disease has become associated with other conditions like glaucoma, rheumatoid arthritis, Sjogren's syndrome, post-LASIK surgery and patients taking anti-depressants, Dr. Penny Asbell, an ophthalmologist at the Mount Sinai Department of Ophthalmology in New York, said.

The condition causes a reduction of tears being produced needed to lubricate and nourish the front of the eye called the tear film. In a normal state, the layer provides the cornea and conjunctiva a healthy barrier from exposure as well as smoothing the anterior surface to provide the best optics for good vision. If the tear film becomes unhealthy and begins to break down symptoms of irritation as well as unstable and intermittently changing vision can happen.

Tear production tends to slow as people get older. By the time someone reaches 65 they can lose up to 65% of their tear volume compared to when they were 18. The condition can be exacerbated by medical conditions that begin to present themselves with age as well, by environmental influences like air pollution and windy, dry climates and by use of systemic medications.

Yet, it is not exclusive to seniors. Dr. Asbell said more cases are being reported in the young, most likely due to the increasing amount of time they spend looking at computer screens and digital devices that decreases the amount of blinking and lubrication of their eyes suffers.

Tears have a fairly intricate composition as they are made up of hundreds of different types of molecules, including natural antibiotics called lysozymes, vitamins, minerals, mucus, oil and water.

Dry Eye Disease is a persistent condition, much like chronic pain, that can interfere with quality of life due to constant dry, itchy, gritty feeling and red or swollen eyes. It is seen as a condition that is a multifactorial disease affected by inflammation, tissue degeneration and tear production deficit. It’s also one of the main reasons patients go to see an eye doctor.

Currently, there are only two FDA-approved treatments for Dry Eye Disease — Allergan’s Restasis and Shire’s Xiidra, which focus almost exclusively on suppressing inflammatory aspects of the disease.

Luxembourg-based Mitotech, which is a clinical stage biotechnology company focused on developing treatments for age-related disorders like Dry Eye Disease, recently received several U.S. patents covering various formulations of its lead compound SkQ1 and its use in ophthalmology.

“The interesting thing is that it’s a whole different mechanism improving cellular activity,” Dr. Asbell, who has had first-hand laboratory experience with SkQ1, said. “It’s totally different from Restasis and Xiidra. Both work as anti-inflammatory agents, but SkQ1 improves cellular function and has anti-oxidant effect.”

SkQ1 works on a cellular level by reducing damage caused by excessive reactive oxygen species (ROS), which are types of free radicals that play an important role in cell signaling. SkQ1 also selectively protects membrane’s cardiolipin from oxidation and by doing so prevents mitochondrial dysfunction and process of cell death called apoptosis. Another feature of the compound is that its oxidation chemistry allows it to be recycled in the mitochondria, creating a renewable antioxidant. The company has built its clinical development program to leverage SkQ1 across age-related disorders that could include treating neurodegenerative diseases like Parkinson’s and Alzheimer’s.

“SkQ1 was developed as an agent fighting a spectrum of age-related diseases at their root, which in our hypothesis is oxidative stress inside mitochondria,” Natalia Perekhvatova, Mitotech’s chief executive, said. “In case of Dry Eye Disease our ophthalmic solution Visomitin has been shown not only to suppress inflammation, but also to protect corneal and conjunctival cells from damage and to promote health of lacrimal glands, therefore addressing the disease from multiple angles.”

Mitotech’s program for the treatment of Dry Eye Disease is focused on Visomitin, which is approved in Russia and had a successful Phase II study in the U.S. that indicated statistically significant effect of SkQ1 on both signs and symptoms of dry eye.

The company is currently preparing Visomitin for Phase III trials, with a goal of getting the compound before the FDA by 2019.

“SkQ1’s innovation is that it is not a ‘me too’ drug,” Dr. Asbell said. “It’s a totally different way of addressing the problem of dry eye.”


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