Approximately 16 million Americans have been told by their doctor that they have Dry Eye Disease – the itchy, uncomfortable and inconvenient condition that remains the number one reason people go see an ophthalmologist.
People with Dry Eye Disease either produce poor quality tears or do not produce a sufficient amount of tears to nourish and lubricate the front of the cornea, leading to eyes that feel chronically irritated, gritty, red, and scratchy.
But, despite its name, Dry Eye Disease is much more than just insufficient tears. The condition is multifactorial, and it’s characterized by underperforming tear production as well as inflammation and tissue degradation.
Treatments for the condition aim to replenish or maintain a normal amount of tears to minimize discomfort. But according to Robert Ritch MD, Professor of Ophthalmology at New York Medical College, the therapy options currently available to patients with Dry Eye Disease just don’t cut it.
Artificial tears, for example, provide short-term relief and have to be applied frequently – with many patients using these types of drops several times throughout the day. Dr. Ritch says that patients also often make the mistake of using artificial tears as needed, when their eyes feel dry, rather than using them prophylactically as they should be.
When it comes to prescription-strength options, there are just two eye drops that have been cleared by the FDA to treat dry eye. Patients can be prescribed either Allergan’s Restasis or Shire’s Xiidra, which was approved just last year. These two drops have a limited effect against Dry Eye Disease, however, because they act primarily as anti-inflammatory agents – and fail to address the tissue degeneration and tear production deficit that also characterize the condition.
Fortunately, patients suffering from the symptoms of Dry Eye Disease can start looking forward to a new treatment option that targets the condition from all three angles. Mitotech, a biotechnology developer based in Luxembourg, has been working on a novel compound that goes beyond the current treatment paradigm to approach the multifactorial nature of the disease.
Mitotech’s lead molecule, called SkQ1, has been clinically proven to relieve inflammation, tissue degeneration, and tear quality deficit in patients with Dry Eye Disease. Unlike the current standards of care, SkQ1 deals with the condition on a cellular level by protecting the eye from oxidative stress.
Cells produce a type of free radical called reactive oxygen species (ROS), which are important for cell signaling and general cellular function. Oxidative stress – a phenomenon widely evident in patients suffering from Dry Eye Disease – happens when the amount of ROS produced inside cells and tissues grows beyond normal levels. Naturally-occurring antioxidants typically keep ROS levels in check, but excess ROS react with nearby lipids, proteins or other cellular components – which hurts normal cell function.
This is where Mitotech’s SkQ1 comes in. One of the primary sources of ROS inside cells is an organelle called the mitochondria, but natural antioxidants aren’t able to penetrate mitochondria to neutralize excessive levels of free radicals. SkQ1 is part of a new class of molecules called mitochondria-targeted antioxidants – and it has already been proven to target and neutralize mitochondrial ROS to restore cellular function.
In Russia, Mitotech has already won regulatory approval for its eye drop formulation of SkQ1, called Visomitin – and about 1 million units of Visomitin have been sold in the Russian market since it was commercially launched. A recent clinical study completed in Russia showed a significant effect of SkQ1 on a range of dry eye signs and symptoms for a diverse patient population. On top of that, there were no safety issues observed.
“The study showed that the drug protected cornea from damage, improved quality of the tear and made patients feel better at the same time,” said Natalia Perekhvatova, Chief Executive Officer of Mitotech. “But most importantly, feedback we are getting from the market is very positive, both from physicians and patients.”
Here in the US, the company has advanced the drug candidate past a successful Phase 2 clinical evaluation, and is getting ready for Phase 3 with the aim to score an FDA approval by 2020.
Mitotech isn’t stopping there. Because SkQ1 is a mitochondrial stabilizer that improves cellular function, its potential reaches far beyond just Dry Eye Disease. According to Dr. Ritch, mitochondria lie at the basis of all neurologic diseases – including Glaucoma, Alzheimer’s Disease, Huntington’s Disease, Parkinson’s Disease, and many others.
“When the mitochondria die, the cell dies,” Dr. Ritch says, “If you preserve the mitochondria in those diseases where mitochondria die, you improve those diseases.”
Capitalizing on this wide-open potential for its mitochondria-targeted antioxidant, Mitotech is already looking forward to launching a clinical program for an oral formulation of SkQ1 in the US. They are targeting Multiple Sclerosis first, then moving on to develop a formulation for Alzheimer’s and Parkinson’s. According to the company’s CEO, their scientists have conducted multiple animal experiments in neurodegenerative disorders where SkQ1 showed remarkable efficacy.