Wrinkles—look out! A new and wonderfully effective treatment for the reduction of wrinkles has been approved by the FDA. Developed by EndyMed Medical Ltd, this new treatment system is now being called the EndyMed PRO, as opposed to its original name, Imagine. Imagine indeed: imagine a treatment that erases those unsightly facial wrinkles with a gentle and non-invasive therapy.

There are lots of other benefits to the EndyMed PRO, too, including treatment customized for each patient, and a short treatment with no recovery time. No pain, which is always a plus, and no side effects. Go right back to work, or shopping, or watching your soaps. You will see immediate improvement coupled with long term results. In studies which were done to determine the safety and effectiveness of the EndyMed PRO, dermatologists found that more than 80 percent of patients still had significant reduction of their wrinkles a full three months after treatment. This clinical study was done in several centers, and results were consistent throughout.

This is actually the first product of its type to be approved for marketing in the US. Quite a feather in the cap of EndyMed, as it makes them a real contender in the aesthetics market, not just in America, but around the world. EndyMedPRO uses third generation 3DEEP(TM) radio frequency technology, which means it’s a new and improved version.

The way I understand it is that the 3DEEP technology provides for effective individual contouring, and apparently uses minimal energy flow to the surface of the skin. The specialized technology controls not only the depth, but the power and three-dimensional pattern of the radio frequency energy. What does that mean? It means you get a totally painless, safe and non-invasive treatment which is very effective at reducing those wrinkles. Doesn’t get much better than that!

Alas, Accutane, you are no more! Economic and legal factors have combined to force pharmaceutical company Hoffman-La Roche to announce that they are discontinuing the acne drug Accutane. This didn’t come as a surprise to dermatologists, as pharmacists have been in the habit for quite some time of filling prescriptions for Accutane with the generic equivalent isotretinoin. Unfortunately for Roche, this has had the effect of lowering their market share drastically, so that their current share is only 3%, leaving the rest of the market to the lower-priced generics Amnesteem, Sotret, and Claravis.

Dermatologists disagree in their perceptions of these generics. Some feel that they are just as good; others have said they might as well give their patients a placebo. One doctor interviewed claimed that it was necessary to prescribe higher doses of the generics, and keep patients on them longer, in order to achieve the same effect as Accutane. Patients want to pay as low a cost or co-pay as possible, and Accutane, like all branded medicines, is more expensive. Bottom line—the wallet rules.

Legal issues have also plagued Roche. Besides the millions of dollars any pharmaceutical company spends to develop, test, and market a new drug, Roche has spent millions on lawsuits defending Accutane. IBD (Inflammatory Bowel Disease), depression, suicide and birth defects have been linked to this drug, resulting in hundreds of lawsuits and FDA warnings on labels. Similar lawsuits have been filed against manufactures of the generic isotretinoin.

With the situation Roche found themselves in–millions spent to bring the drug to market, millions spent defending themselves against lawsuits, market share down to 3%– it’s no wonder they decided to pull the plug. But what does that mean for the future, and the patients who need it?

Dermatologists are concerned that with Accutane out of the picture, the pharmaceutical companies who produce the generics will increase their prices. They have already begun to face the same legal issues as Roche. It would be a shame if this drug, a boon to many people over the years who have severe acne, was pulled off the market entirely.

On June 8, the U.S. Food and Drug Administration approved a 12 month labeling supplement for Evolence, a collagen-based facial filler.  The labeling reflects the results of an FDA review of additional clinical data that demonstrated safety and efficacy of EVOLENCE for a period of 12 months.  EVOLENCE, collagen-based dermal filler used to correct of moderate to deep facial wrinkles and folds, is the first and only collagen dermal filler recognized to provide results through 12 months after an initial treatment. EVOLENCE, manufactured by Ortho Dermatologics, was originally introduced in the US in 2008 with a six-month duration labeling.

EVOLENCE is formulated from natural collagen to replace the body’s lost collagen, adding volume and structural support in depleted areas, to create a more naturally younger appearance. Because natural collagen is used, patients require no pre-testing. Results are immediate and visible, with minimal to no bruising or swelling. 

EVOLENCE is the first and only collagen-based dermal filler recognized in the US to provide results through 12 months after an initial treatment.