Biotech focus

Oculus Innovative Sciences Tackling Eczema from the Inside Out and Outside In

Many may take skin for granted, but it is one of the most complex and important parts of the body.  That is certainly not the case, though, for approximately one-third of Americans who suffer from some type of skin condition.  After decades of a saturated dermatology market and relatively limited investment, better understanding of the pathogenesis of skin conditions as well as the commercial success of new treatments has resulted in newfound interest in dermatologic products in recent years.  These market conditions underscored the decision of specialty pharmaceutical company Oculus Innovative Sciences (NASDAQ: OCLS) to refocus its efforts exclusively on building their dermatology portfolio late in 2014, a move that has the company back on the path toward a cash flow positive position.

Despite the advancements, especially with biologics for psoriasis, there is still an unmet need for many skin conditions, including atopic dermatitis and eczema, an umbrella term for conditions such as atopic dermatitis (the most common type of eczema), irritant and allergic contact dermatitis and hand eczema.  In all cases, eczema is characterized by red, irritated and inflamed skin.  The National Eczema Association (NEA) estimates that 31.6 million people in the U.S. have symptoms of eczema, including about 18 million with moderate to severe eczema.

Although it is believed that atopic dermatitis and eczema have a hereditary component and that ceramide deficiency is part of the problem, the underlying cause of eczema is still not fully understood.  It is known that atopic dermatitis nearly always presents first before the age of 5, affecting up to 10.7% of children.  It is also recognized that about 90% of atopic dermatitis patients are colonized with the bacteria, staphylococcus aureus, which can lead to further barrier issues.  NEA also notes that a recent study found the prevalence of eczema in U.S. adults could be as high as 10.2% of the population, meaning that the condition simply doesn’t go away as a person ages.

“Regardless if a condition is labeled contact dermatitis or eczema or atopic dermatitis, these conditions all have the same symptoms of transepidermal water loss and an impaired stratum corneum,” commented OCLS CEO Jim Schultz in a phone conversation.  “No one knows exactly why it happens, but these skin dysfunctions lead to the hallmarks of the conditions: inflammation, pruritus, dry and scaling skin.”

Without a “cure” for atopic dermatitis, management of each of these symptoms through a deep understanding of how the skin functions is the best answer, explained Schultz.  In April, Oculus launched its latest product for eczema, called Ceramax Skin Barrier Cream, which is built on Lipogrid® technology. 

In a healthy stratum corneum, the outermost layer of the epidermis (skin), corneocytes containing water and lipids build a membrane to keep the skin hydrated. A disrupted or deteriorating skin barrier allows more moisture to be released, leading to the skin’s cells becoming cracked, dry and brittle.  Prolonged impairment causes additional breakdown, inflammation, blistering and pain.

To most efficiently treat atopic dermatitis, the goal is to eliminate or reduce exposure to any causative agent, reduce inflammation, hydrate the skin, protect the skin and repair the skin/skin barrier.  Historically, dermatologists have used moisturizing agents independently or in combination, topical corticosteroids, oral steroids, topical immunomodulators, topical and oral antibiotics and antihistamines in a bid to accomplish the goal.  However, long-term exposure to steroids and antibiotics is documented to have negative effects, creams can be greasy and difficult to spread, lotions can be too thin and foams are not ideal for facial applications.

To overcome these challenges, Oculus has brought Ceramax® to market. Ceramax utilizes a blend of ingredients, including leveraging the properties of physiological lipids to meet the goals of skin repair through an inside-out and outside-in approach.  This is due to the fact the physiological lipids can be absorbed into the stratum corneum, with some reaching the viable epidermis while also protecting the outside of the skin while it heals.

The Lipogrid technology at the heart of Ceramax includes three main ingredients:  physiological lipids, glycerin and dimethicone, mixed with water. 

As mentioned, ceramide deficiency is often a culprit in eczema.  The physiological lipids are comprised of 60% ceramide, 20% cholesterol and 20% palmitic acid, all naturally occurring lipids precisely arranged to mimic the natural structure of human membrane.  This technology allows all the physiological lipids to blend in with the natural lipid building blocks and penetrate beyond the stratum corneum, where they also contribute to the synthesis of ceramides, cholesterol, and other free fatty acids. 

Glycerin is a humectant that sits on the skin, attracting moisture to help improve softness and elasticity.

Dimethicone is an unmodified silicone that stays on or near the skin’s surface because dimethicone molecules are too large to pass through the upper cells of the skin.  Further, dimethicone doesn’t readily mix with the water and protein inside the skin’s cells, ultimately forming a barrier layer on the skin.

The result is Ceramax hydrating, protecting and repairing the skin from both the inside out and the outside in, resulting in reduction of inflammation, itch, redness, etc.

The penetration of lipids has been scientifically validated through clinical research and a study led by Ruby Ghadially, MD, at the University of California San Francisco.  Using fluorescent microscopy on an animal model, Dr. Ghadially showed the arrangement of physiological lipids in Lipogrid technology to penetrate the skin into the viable epidermis, whereas petrolatum could not.

A clinical study conducted by Joseph Fowler, MD, compared Ceramax to ointment and lotion comparators for the treatment of chronic hand contact dermatitis caused by occupational exposure.  The results from the study showed Ceramax to outperform comparators with respect to reducing the symptoms, as well as patients preferring the non-greasy Ceramax formulation (which likely helped with patient compliance), in addition to patients being three-times more likely to stop concomitant use of steroids versus the comparator groups.

Oculus does not break down its overall sales into segments for each product, so it is difficult to gauge exactly how strong physician adoption has been since Ceramax hit the market three months ago.  The company has, however, released information on impressive growth in total prescriptions filled for its group of dermatology products.

Specifically, the number of prescriptions filled grew 52.2% from 5,666 in the March 2015 quarter to a record 8,624 in the March 2016 quarter.  Quarter-over-quarter growth during the year averaged a robust 25%.  Across April and May, total prescriptions filled were 7,304, with Oculus attributing part of the expansion to Ceramax sales.  This growth is important because a physician is more likely to prescribe additional Oculus products (marketed under the “Intraderm” brand name) as he/she becomes familiar and comfortable with the durable effects of the brand.

Given the continued sales growth, interested parties will be closely watching for results over the following quarters.  Oculus has previously mentioned their target of becoming cash flow neutral during the second half of 2016 and the latest quarter was the best for prescriptions filled in the company’s history.