Approximately 20 million Americans suffer from Dry Eye Disease – the itchy, uncomfortable and inconvenient condition that remains the number one reason for ophthalmologist visits.
People with Dry Eye Disease produce poor quality tears and/or do not produce a sufficient quantity of tears to supply nourishment and to lubricate the cornea, leading to eyes that look red and feel chronically irritated, gritty, and scratchy.
But, despite its name, Dry Eye Disease is much more than just insufficient and/or poor quality tears. The condition is multifactorial and is associated with inflammation and tissue damage.
Only three prescription drugs have been approved by the FDA to treat dry eye: Allergan’s Restasis, Sun Pharma’s Cequa and Shire’s Xiidra. Often taking a number of weeks to show benefit, these three eye drops have limited efficacy against Dry Eye Disease, probably because they act primarily as anti-inflammatory agents. They do not appear to directly address the tissue damage and tear deficit that also characterize the condition. In addition, these approved products often cause eye discomfort - one of the symptoms of dry eye itself.
Fortunately, biotechnology companies have taken notice and have been working on novel treatment approaches. One particular biotechnology developer, Mitotech, has been working on a new compound that goes beyond the current treatment paradigm to address the multifactorial nature of Dry Eye Disease.
Mitotech’s lead molecule, SkQ1, addresses dry eye by protecting the eye from oxidative stress, which has been shown to be a major factor in the pathophysiology of Dry Eye Disease – including reduced tear quality, tissue damage and inflammation. It is a challenging task to approach such a complex and understudied disorder with a radically new treatment, but the company has already completed an encouraging Phase 2 study in dry eye patients in the U.S. and, based on the Phase 2 results, has initiated a larger U.S. Phase 2b/3 clinical study named VISTA-1.
“Addressing the multiple aspects of Dry Eye Disease with a single drug is not a trivial undertaking and requires approaching it with a radically new mechanism of action in order to be successful. That’s Mitotech’s strongest competitive advantage,” said Natalia Perekhvatova, Chief Executive Officer of Mitotech. “At the same time, the challenge is not only to address all factors of the disease but also to demonstrate early onset of action while doing so and to maintain an excellent tolerability profile. Results of our early studies indicated that SkQ1 can tick all of those boxes, and we are looking forward to analyzing VISTA-1 data, which we hope will provide critical confirmatory efficacy and safety information. Tolerability is a very important factor for dry eye patients, particularly minimizing drug-associated ocular discomfort, as this is one of the most common symptoms of the disease.”
Mitotech enrolled roughly 450 patients in the VISTA-1 study which evaluates the efficacy of two different doses of SkQ1 eye-drop formulation versus vehicle. Dry Eye Disease patients were exposed to 8 weeks of randomized, double-masked treatment. The study was designed to evaluate the effects of SkQ1 on a broad range of the signs and symptoms of dry eye as early as 4 weeks from treatment initiation, which is very ambitious in comparison to time-to-effect of currently available prescription drugs.