Richmond, Texas (January 15, 2015)
OCuSOFT® HypoChlor™ (Hypochlorous Acid 0.02%) Gel & Spray
OCuSOFT Inc., an ophthalmic pharmaceutical company (the “Company”) with an established reputation for innovation in eyelid hygiene and ocular health, is pleased to announce the availability of OCuSOFT® HypoChlor™, a 0.02% concentration of Hypochlorous acid in both Spray and Gel formulation which can be used to supplement its existing OCuSOFT® Lid Scrub® family of eyelid cleansers in the most severe cases. The Company also wishes to take this opportunity to better clarify the role of Hypochlorous acid in managing eyelid care. We believe that recent public statements concerning Hypochlorous acid and its role in comparison to Over-The-Counter (OTC) eyelid cleansers have contained statements which may have left the ophthalmic community confused and could lead to unnecessary patient costs. This Press Release seeks to clarify the Company’s position on Hypochlorous acid and the benefits of OCuSOFT® HypoChlor™.
Hypochlorous Acid OTC vs. Rx Claims—Understanding the Difference
The FDA requires that Hypochlorous acid is registered as a medical device which may be marketed by the filing company as either a prescription (Rx) or OTC product. The basis of Rx vs. OTC relies on the claims that can be made of the product as contrasted with ingredient concentration. More specific claims can be made if the product is marketed as an Rx (“… for use under the supervision of healthcare professionals…; for moistening absorbent wound dressings and cleaning minor cuts, minor burns…” etc.) however, more general claims are made if the product is OTC (“…immediate care of minor cuts, minor scrapes and minor burns.”) Generally, the Rx vs. OTC has nothing to do with percentage of principle ingredient. For example, OCuSOFT® HypoChlor™ Solution and OCuSOFT® HypoChlor™ Gel both contain 0.02% Hypochlorous acid and are OTC. Other company’s brands are available at lower strengths than OCuSOFT® HypoChlor™ yet one may be Rx and another OTC.
OCuSOFT® Lid Scrub® Original & PLUS Formulas
OCuSOFT® Lid Scrub® Original and OCuSOFT® Lid Scrub® PLUS are effective and intended for continuous daily eyelid hygiene use. The root cause of anterior blepharitis is the overproduction of oils. Mild surfactants in OCuSOFT® Lid Scrub® eyelid cleansers act to dissolve and remove oil, debris and desquamated skin. Hypochlorous acid formulas do not contain these surfactants and thus are largely ineffective in debriding the oil, scales and debris often associated with eyelid irritations. Accordingly, in the most severe cases where Hypochlorous acid might be most beneficial, it is suggested to use Combination Therapy including both a surfactant cleanser and Hypochlorous acid to achieve optimum results.
OCuSOFT® Lid Scrub® Original Formula is principally a surfactant formulation and acts to remove oil, debris and desquamated skin in various eyelid conditions. OCuSOFT® Lid Scrub® PLUS contains a patented moisturizer and preservative blend that effectively eradicates seven different strains of bacteria commonly found on the eyelids without the need of prescription cleansers.
Regarding the effectiveness of OCuSOFT® Lid Scrub® PLUS, Dr. Marguerite McDonald of Ophthalmic Consultants of Long Island and Clinical Professor of Ophthalmology, NYU School of Medicine, New York, US, goes on to say, “In a time-kill study, the anti-bacterial effectiveness of OCuSOFT® Lid Scrub® PLUS was independently tested against a variety of pathogens. In particular, S. epidermidis, a leading cause of post-operative endophthalmitis was tested. These studies demonstrated a 5.5 log reduction confirming its significant effectiveness.”
Hypochlorous Acid in Eye Care
It is interesting to note that debridement claims made in an Rx formula are due to the spray projectile packaging of all Hypochlorous acid products rather than strength of the concentration. Significantly, none of the Hypochlorous acid formulations on the market contain any surfactants to remove oil from the eyelids. Most expert ophthalmologists and optometrists agree that the surfactant components of existing eyelid cleansers are necessary to remove excessive oil, debris and desquamated skin from the eyelids. In the article, “Alternative Products Available to Combat Ocular Surface Disease” that ran in the November 2014 issue of Primary Care Optometry News, Katherine Mastrota, O.D. of Omni Eye Services recommends pairing a Hypochlorous acid product with a “doctor recommended surfactant product.”
Hypochlorous Acid Market in Eye Care
While there are patents for manufacturing processes of Hypochlorous acid, there are currently no patents for Hypochlorous acid solution compositions. As such, there are many competitors of Hypochlorous acid with the same composition in the wound cleansing market but only two operating in the eye care space. Accordingly, established companies offering eyelid hygiene products such as OCuSOFT® operating within the eye care market have distinct advantages in their product offerings to physicians. Therefore, if Hypochlorous acid is successful within eye care, it is logical to expect other competitive products will enter the market leading to lower prices which will benefit both the patient and the doctor.
Eyelid Hygiene Innovation
In 1987, OCuSOFT® introduced the first commercial eyelid cleanser on the market. Although there has always been competition, OCuSOFT® dominates the commercial eyelid cleanser market holding as much as 80% market share. This dominance is due to its reputation within the ophthalmic community of quality products at reasonable prices thus offering significant patient benefits. While the OCuSOFT® Lid Scrub® family of cleansers is available in most retail chains including, but not limited to: CVS, Walgreen’s, Rite-Aid, Wal-Mart, Kroger, Publix, etc., doctor-oriented programs are available to practitioners helping to reduce patient cost. Availability of OCuSOFT® Lid Scrub® is also easily achieved through contractual arrangements with drug wholesalers such as McKesson, Cardinal, Amerisource-Bergen, etc.
Eyelid Hygiene Products Added to Product Portfolio
As the innovators in Eyelid Hygiene, OCuSOFT® is proud to extend its offering of eyelid products to manage all types of eyelid conditions. From OCuSOFT® Lid Scrub® Original and OCuSOFT® Lid Scrub® PLUS formulas that are currently available through retail and wholesalers, OCuSOFT® is pleased to introduce the following innovations to its Eyelid Hygiene product portfolio: OCuSOFT® Lid Scrub® PLUS Swabstix™ and Oust™ Demodex® Swabstix™ used in-office by practitioners to help manage Blepharitis and demodex mites; and, OTC OCuSOFT® HypoChlor™ Solution and OCuSOFT® HypoChlor™ Gel used as an adjunct to OCuSOFT® Lid Scrub® products in the most severe Blepharitis cases.
Blepharitis and Dry Eye
Although Blepharitis and Dry Eye are related, their respective treatments as well as their market shares should not be lumped together. The Dry Eye market is approximately a $500 million market; however, the eyelid hygiene market is a small fraction of that. OTC artificial tears comprise the bulk of the Dry Eye market share. Clinically, the oil component of the tear film induces both Blepharitis and Dry Eye. As such, OCuSOFT® has introduced OCuSOFT® Retaine® Ophthalmic Emulsion lubricant eye drops. These novel patented “oil-in-water” eye drops are now available at retail exclusively through Walgreen’s.
OCuSOFT® HypoChlor™ 0.02% concentration of Hypochlorous acid in both Spray and Gel formulation (OTC), when used in the most severe cases and in combination therapy, can lower patient costs when compared to an Rx cleanser. Troy Smith, Vice President Professional & Technical Relations of OCuSOFT Inc., comments, “In patient and physician
communications, it is important that careful thought and consideration go into public statements. Doctors utilize such statements in clinical practice and misinformation, whether intentional or otherwise, may affect clinical outcomes or alternatively add to patient costs. This is particularly true for seniors on fixed incomes where cost is of paramount concern.”
In an attempt to better clarify the role of Hypochlorous acid in managing eyelid care and to correct recent public statements concerning Hypochlorous acid and its role in comparison to OTC eyelid cleansers the Company has issued this Press Release. However, nothing contained herein is a guarantee of certain results regarding cost or otherwise. In this regard, this Press Release contains forward-looking statements and opinions. Such statements and opinions are based upon management’s current research, practice, expectations, assumptions, theory and beliefs. The words “can”, “believe”, “may”, “will,” “estimated,” “potential” and “expectation” and other like words are intended to identify the forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. The forward-looking statements in this Press Release speak only as of this date, and the Company disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
About OCuSOFT, Inc.
OCuSOFT, Inc. is a privately-held Richmond, TX USA-based ophthalmic research, development and supply company with an established reputation for innovation, particularly in the area of Ocular Surface Disease (OSD). Since 1986, OCuSOFT® served the ophthalmic industry with a unique selection of proprietary brands. A pioneer in ophthalmology, OCuSOFT® introduced the first eyelid cleanser, the first topical anesthetic gel, the first “leave-on” antibacterial eyelid cleaner, the first supplement to enhance botulinum toxin injections and the first fourth generation preservative-free ophthalmic emulsion eye drop. Today, the company is most recognized for its #1 Doctor Recommended Brand of Eyelid Cleansers, OCuSOFT® Lid Scrub®, in addition to its standing as the preferred distributor of ophthalmic products and supplies by eye care professionals. For more information, please call 800-233-5469 or visit www.ocusoft.com.
About Marguerite McDonald, M.D., F.A.C.S.
Dr. McDonald works at the Ophthalmic Consultants of Long Island and she is Clinical Professor of Ophthalmology, NYU School of Medicine, New York, US; Adjunct Clinical Professor of Ophthalmology at Tulane University Health Sciences Center, New Orleans, Louisiana, US; and a cornea specialist with the Ophthalmic Consultants of Long Island, Lynbrook, New York, US. Dr. McDonald has over 1,200 publications in refractive surgery, cornea, ocular infections and allergy, and ocular surface disease (dry eye and blepharitis). Dr. McDonald has been honored with selection to the editorial boards of several publications, including the Journal of Cataract and Refractive Surgery and the Journal of Refractive Surgery.
Contact: Troy Smith, Vice President Professional & Technical Relations