Sonoma Pharmaceuticals Receives Three New United Arab Emirates Regulatory Approvals: Acuicyn® for Management of Blepharitis, Microsafe® Oral Care for Mucositis and Sinudox® for Chronic Sinusitis
PETALUMA, Calif., Jan. 09, 2018 (GLOBE NEWSWIRE) -- Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA, warrants SNOAW), a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced it has received three new regulatory approvals from the United Arab Emirates Ministry of Health & Prevention.
The first approval is for Acuicyn® eyelid and eyelash hygiene, an antimicrobial solution (hypochlorous acid) indicated to treat symptoms and causes of blepharitis on the eyelid and eyelash. Acuicyn kills microorganisms which can cause irritation, infection and ocular surface disease.
The second approval is for Microsafe® Oral Care, an antiseptic mouth and throat rinse (hypochlorous acid) that eliminates harmful bacteria, viruses and fungi. It relieves symptoms of pain and inflammation caused by mucositis while accelerating the healing process of wounds and ulcerations in the oral cavity and throat.
The final approval is for Sinudox® Nasal Cleansing Spray, an antimicrobial solution (hypochlorous acid) intended for nasal irrigation to penetrate, clear and clean the nasal passages and sinus cavity in post-operative, preventative and symptomatic nasal care.
“The regulatory process in the United Arab Emirates is extremely rigorous and considered the gold standard for Southwest Asian nations. Therefore, securing these three UAE approvals will certainly open the path to growth and help expedite regulatory approvals from many other countries in the region,” said Safwan Abdallah, MicroSafe Group’s director of operations. “We anticipate launching all three products across the United Arab Emirates in February 2018.”
“The MicroSafe group continues to build with our proprietary hypochlorous acid platform throughout the Middle East with approvals and products across dermatology, wound care, disinfectants and now personal care. We are very excited for the MicroSafe Group and honored to be partnered with them,” said Bruce Thornton, VP of international operations for Sonoma Pharmaceuticals.
Contact MicroSafe Group at email@example.com for distribution inquires relative to the Middle Eastern countries.
Blepharitis is one of the most common ocular conditions characterized by inflammation, scaling, reddening, and crusting of the eyelid. This condition may also cause burning, itching, or a grainy sensation when introducing foreign objects or substances to the eye. Although blepharitis is not sight-threatening, it can lead to permanent alterations of the eyelid margin. The overall etiology is a result of bacteria and inflammation from congested meibomian oil glands at the base of each eyelash. Other conditions may give rise to blepharitis, whether they be infectious or noninfectious, including, but not limited to, bacterial infections or allergies. In a survey of U.S. ophthalmologists and optometrists, 37% to 47% of patients seen by those surveyed had signs of blepharitis, which can affect all ages and ethnic groups. One single-center study of 90 patients with chronic blepharitis found that the average age of patients was 50 years old.
Mouth and throat sores, also called mucositis, look like ulcers and can be red and swollen. Pain from these sores can affect a person’s ability to eat, drink, chew, swallow, and talk. If one’s immune system is suppressed, they may be more likely to get an oral yeast infection. Mucositis is oftentimes a side effect of chemotherapy in cancer patients with a 40% incidence in standard-dose patients and an 80% incidence in hematopoietic stem cell transplantation. There is nearly a 100% incidence in patients who receive radiation therapy for neck and head cancers.
About Chronic Sinusitis
Chronic sinusitis is a common disease worldwide, particularly in places with high levels of atmospheric pollution. In the Northern Hemisphere, damp temperate climates along with higher concentrations of pollens are associated with a higher prevalence of chronic sinusitis.
Chronic sinusitis is one of the more prevalent chronic illnesses in the United States, affecting persons of all age groups. The overall prevalence of CRS in the United States is 146 per 1000 population. For unknown reasons, the incidence of this disease appears to be increasing yearly. This results in a conservative estimate of 18-22 million physician visits in the United States each year and a direct treatment cost of $3.4-5 billion annually. Chronic sinusitis is the fifth most common disease treated with antibiotics. Up to 64% of patients with AIDS develop chronic sinusitis.
About Sonoma Pharmaceuticals, Inc.
Sonoma is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com.
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “continues,” “expedite,” and “anticipate,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Sonoma Pharmaceuticals®, Acuicyn® and Sinudox® are registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.
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Sonoma Pharmaceuticals, Inc.
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Released January 9, 2018