Refissa™ Tretinoin Cream USP Introduced

FDA approved, new formulation, fragrance-free, prescription cream available for the treatment of fine lines and wrinkles

(New Jersey, June 3, 2009) — Spear Dermatology Products, Inc. announces Refissa™ a new formulation of Tretinoin, approved by the U.S. Food and Drug Administration (FDA). Refissa is the only 0.05% prescription strength, fragrance-free, emollient-based Tretinoin Cream. This topical Tretinoin cream helps to reduce fine facial wrinkles, rough skin, and irregular pigmentation. Refissa’s emollient formulation is for patients with normal to dry skin, who should also protect their skin from the sun by wearing a daily sunscreen.

Most dermatologists view topical retinoids as the cornerstone of treatment for sun damaged skin and acne.1 Most retinoids, however, are formulated and indicated exclusively for the treatment of acne. Among topical retinoids, Tretinoin is the “Gold Standard” of treatments, and Refissa, formulated in a moisturizing base, is an ideal option for mature patients with drier photo damaged skin.

With the launch of Refissa, Spear Dermatology Products, Inc. is well poised to be at the forefront of the booming prescription topical facial rejuvenation market. Total sales for this market exceeded $394m in 2002 and increased to more than $494m in 2007. It is expected that market sales will surpass $513m by 2012.2 Refissa stands out from all other facial rejuvenation products as it’s the only 0.05% strength prescription Tretinoin cream on the market that is both fragrance-free and contains a moisturizing, emollient base that is proven to be clinically safe and effective.

Refissa has gone through the extensive testing required to earn FDA approval and offers patients a safe, cost-effective prescription alternative to expensive cosmetic surgery or procedures. A 40 gram tube of Refissa may last 2-3 months, depending on individual usage patterns and costs on average, less than $2.00 per day. Refissa will be available for distribution during the first week of June, 2009.

“Despite the recession, luxury items like skin care and anti-aging products continue to be in high demand,” said Stephen Basile, Sr. Vice President Sales and Marketing, Spear Dermatology Products, Inc., “This growing shift of consumers opting to use less invasive skin rejuvenation products is fueling an ever-growing market for Baby Boomers who want to spend less to effectively treat their sun damaged skin and improve the appearance of their skin.”

Refissa contains tretinoin, a derivative of vitamin A, and works deep at the skin’s cellular level to increase collagen, which the body produces less of with age.3 According to K.L. Spear, MD, dermatologist and President of Spear Dermatology, “Refissa has been proven in a clinical trial to be effective in the treatment of fine facial wrinkles, tactile roughness of the skin, as well as irregular pigmentation from the sun.”

Important Safety InformationRefissa 0.05% is a prescription medicine that may reduce fine facial wrinkles and mottled hyperpigmentation in patients who also protect their skin from the sun and wear sunscreen daily. Refissa does not eliminate wrinkles, repair sun damaged skin or reverse photo-aging. Avoid medicines that may increase your sensitivity to sunlight, ask your pharmacist. Do not use if you are pregnant, attempting pregnancy, or nursing. Refissa, early in treatment, may cause redness, itching, burning, stinging and peeling. Please see Full Prescribing Information at

About Spear Pharmaceuticals, Inc. and Spear Dermatology Products, Inc.

Spear Pharmaceuticals, Inc. is a specialty dermatology company that develops niche products available only by prescription. Spear Dermatology Products, Inc. commercializes products developed by Spear Pharmaceuticals. All of Spear’s products are manufactured in the United States in facilities inspected and approved by the FDA. Products marketed over the last decade include those used in the treatment of acne, actinic keratosis, superficial basal cell carcinoma, fine facial wrinkles, tactile roughness of the skin, and hyperpigmentation. Spear is committed to the ongoing commitment of developing products that help patients restore their skin’s health.

For more information about Refissa, visit

(1) Rabe JH et al. Photoaging Mechanisms and repair: J Am Acad Dermatol 2006: 55:1-19.

(2) Kalorama Information, August 2008. See Important Safety Information above.

(3) Rados C. Science meets beauty: using medicine to improve appearances. U.S. Food and Drug Administration Consumer Magazine.
2004:38(2). Accessed October 2, 2008.