RENOVA now available by prescription

Business Wire, March 6, 1996

RARITAN, N.J.--(BUSINESS WIRE)--March 6, 1996--RENOVA(R) (tretinoin emollient cream) 0.05 percent, which was cleared for marketing by the U.S. Food and Drug Administration in December 1995, is now available by prescription.

RENOVA is the first prescription cream proven to reduce fine facial wrinkles, brown spots and surface roughness associated with chronic sun exposure and the natural aging process when used in addition to a comprehensive skin care and sun avoidance program.

RENOVA is prescribed as an additional therapy for persons who do not achieve satisfactory results using a sunscreen, protective clothing and moisturizers alone. It does not prevent or eliminate wrinkles, repair sun damaged skin or reverse either the aging process or photoaging.

RENOVA is formulated in an emollient cream containing the active ingredient, tretinoin, a form of vitamin A that occurs naturally in the body. The product, marketed by Ortho Pharmaceutical Dermatological Division, will cost patients approximately $10 to $15 per month.

"Most skin creams work on the surface of the skin to remove dead cells and moisturize," said Ellen C. Gendler, M.D., clinical associate professor of dermatology, New York University School of Medicine. "RENOVA is different. It is believed to work on all layers of the skin, including the epidermis where pigmentary changes occur and even the deeper portions of the skin where fine wrinkling is thought to begin."

Gendler emphasized that RENOVA therapy requires a dedicated patient. "The product must be used daily and results are gradual," she said. "To put this in perspective, people who start RENOVA therapy this month and remain committed to the regimen could begin to see visible results in time for summer."

Gendler explained that patients who respond to RENOVA will begin to notice some improvement in their skin -- usually a decrease in surface roughness -- within the first month. By six to eight weeks, brown spots begin to fade. "They can then expect to see a diminishing of fine lines and wrinkles at around three to six months and, in general, maximum benefit by the end of the first six months of therapy," she said. Gendler noted that with discontinuation of RENOVA therapy, a majority of patients will lose most of the product's effects.

More than 300 patients between the ages of 30 and 50 participated in the pivotal clinical studies of RENOVA, which were conducted at eight research centers nationwide. In the studies, patients received treatment with RENOVA or a placebo, in conjunction with a comprehensive skin care and sun avoidance program.

At the end of 24 weeks, physicians noted some signs of skin improvement in 78 percent of patients treated with RENOVA. Sixty-four percent had improvement in fine wrinkling, 65 percent had reduction in brown spots and 51 percent had smoothing of surface roughness. Among patients on placebo, 38 percent had improvement in fine wrinkles, 48 percent had reduction in brown spots and 33 percent had smoothing of surface roughness.

Nearly all RENOVA users experience side effects before seeing visible improvement. These side effects are temporary, usually mild to moderate in severity, and may include some redness, dryness, itching, peeling, or a slight burning or tingling sensation. In clinical studies, these skin reactions were temporary and usually disappeared within a few weeks after therapy began. In most patients, the dryness, peeling and redness recurred after an initial (24 week) decline. During these studies, only four percent of patients discontinued RENOVA therapy due to adverse reactions.

Neither the safety nor effectiveness of RENOVA has been established in people over age 50. In addition, patients with visible actinic keratoses and patients with a history of skin cancer were excluded from the RENOVA clinical trials. Thus, the safety and effectiveness of the product in these populations are not known at this time.

In addition, RENOVA does not reduce coarse or deep wrinkling, skin yellowing, skin looseness, prominent blood vessels or larger areas of abnormal pigment accumulation (lentigines). It also has not been shown to affect sun-induced abnormalities in epidermal cells or skin elasticity.

Furthermore, labelling for RENOVA contains warnings which state:

o RENOVA is a dermal irritant, and the results of continued irritation of the skin for greater than 48 weeks are not known. There is evidence of atypical changes in melanocytes and keratinocytes, and of increased dermal elastosis in some patients treated with RENOVA for longer than 48 weeks. The significance of these findings is unknown.

o Safety and effectiveness of RENOVA in individuals with moderately or heavily-pigmented skin have not been established. -0- Interested consumers can call 800/992-9686 for more information.

CONTACT: Ortho Pharmaceutical Corp.

Lisa Adler, 908/218-6637