Allergan Announces U.S. Food and Drug Administration (FDA) Approval of Latisse(TM) --

First and Only Treatment Approved by the FDA for Hypotrichosis of Eyelashes

New Prescription Product Increases Length, Thickness and Darkness of Eyelashes:

IRVINE, Calif., Dec. 26 /PRNewswire-FirstCall/ -- Allergan, Inc. (NYSE:

AGN) today announced the U.S. Food and Drug Administration (FDA) has

approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel

treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is

another name for having inadequate or not enough eyelashes. LATISSE(TM) is

the first and only science-based treatment approved by the FDA to enhance

eyelash prominence as measured by increases in length, thickness and

darkness of eyelashes.

 

To view the Multimedia News Release, go to:  http://www.prnewswire.com/mnr/latisse/36439/

 

  "LATISSE(TM) fulfills a significant and previously unmet need in the

medical aesthetic marketplace with a product approved by the FDA that

increases the growth of eyelashes, making them longer, thicker and darker,"

said Scott Whitcup, M.D., Allergan's Executive Vice President of Research

and Development. "As the global leader in medical aesthetics, LATISSE(TM)

exemplifies our continuing commitment to developing innovative treatments

that are studied in well-controlled clinical trials, manufactured to

pharmaceutical standards, appropriately labeled for use, and available to

consumers as a prescription product."

 

    Available only through a doctor, LATISSE(TM) is a once-daily

prescription treatment applied to the base of the upper eyelashes with a

sterile, single-use-per-eye disposable applicator. LATISSE(TM) users can

expect to experience longer, fuller and darker eyelashes in as little as

eight weeks, with full results in 16 weeks. To maintain effect, continued

treatment with LATISSE(TM) is required. If use of LATISSE(TM) is

discontinued, eyelashes will gradually return to where they were prior to

treatment over a period of weeks to months (average eyelash hair cycle).

 

    Similar to Allergan's other medical aesthetic offerings, the benefits

of LATISSE(TM) are derived from scientific evidence, its quality

formulation, and medical origin. LATISSE(TM) was clinically tested in a

pivotal Phase III, multi-center, double-masked, placebo-controlled study to

assess its safety and efficacy in which all endpoints (improved eyelash

prominence, length, thickness and darkness) were met. In addition, like

BOTOX(R) (botulinum toxin type A), which was first approved by the FDA as a

medical treatment for eye disorders and was later found to have an

aesthetic benefit, bimatoprost, the active ingredient in LATISSE(TM), was

first approved in 2001 as a medical product to lower intraocular pressure

in people with open-angle glaucoma or ocular hypertension. Patients treated

with bimatoprost for this specific eye condition experienced eyelash growth

as a side effect. The long-term safety of bimatoprost for therapeutic use

has been recognized by the medical community and well established based on

use in 32 clinical trials involving more than 5,700 glaucoma patients and

more than 13 years of clinical trial experience. Given the existing and

substantial clinical and post-marketing safety data with bimatoprost

solution 0.03%, coupled with the positive results from the Phase III

LATISSE(TM) study, LATISSE(TM) provides patients a clinically meaningful

aesthetic benefit with a favorable safety profile.

 

    Bimatoprost is the active pharmaceutical ingredient in the formulation

of LATISSE(TM) and is a structural prostaglandin analog, a lipid compound

derived from fatty acids designed to bind to prostaglandin (PG) receptors.

PG receptors are present in hair, particularly in the dermal papilla and

outer root sheath. Although the precise mechanism of action is unknown, PG

receptors are thought to be involved in the development and regrowth of the

hair follicle,(i) by increasing the percent of hairs in, and the duration

of, the anagen or growth phase.

 

    "As an oculoplastic surgeon who has treated both medical eye conditions

as well as aesthetic needs, I have extensive knowledge of and experience

with the established therapeutic safety profile for bimatoprost," said

Steven Fagien, M.D., F.A.C.S., in private practice at Aesthetic Eyelid

Plastic Surgery in Boca Raton, Florida, and LATISSE(TM) clinical

investigator. "In the clinical study with LATISSE(TM), I observed

statistically significant differences in eyelash growth and resulting

patient satisfaction. Now that LATISSE(TM) is FDA approved, I look forward

to prescribing it to my patients who will enjoy the benefits of more

prominent eyelashes while I remain confident in the treatment's favorable

safety profile."

 

    LATISSE(TM) will be available in the United States by prescription only

and is subject to all U.S. guidelines applicable to dispensing a

prescription product. Based on today's FDA approval, Allergan expects to

launch the product nationwide in the first quarter of 2009. Doctors and

consumers are encouraged to visit http://www.latisse.com for further product andprescribing information

October 17th, 2008

Obagi Medical Products' ELASTIderm Decolletage System Reduces Visible Signs of Aging on Chest and Neck

Study Shows Significant Improvement of Photodamaged Skin LONG BEACH, Calif.--(BUSINESS WIRE)-- Obagi Medical Products, Inc. (Nasdaq:OMPI), a leader in topical aesthetic and therapeutic skin health systems, today announced positive study results at the Fall Clinical Dermatology Conference Meeting showing that use of its ELASTIderm(TM) Decolletage System is highly effective in improving photodamaged skin of the chest and neck, also known as decolletage. The skin care system showed significant improvements in as early as 2 weeks. The treatment was also well tolerated and provided patients with high levels of satisfaction. "In recent years, it has become clear to me that many women are doing a much better job of protecting their faces from sun damage; however, they continue to neglect their neck and chest area. It is common to see a woman with mild photodamage of their face and a heavily pigmented, rough and wrinkled chest. The results of this study speak for themselves. The system is highly effective, with the most obvious improvements in mottled hyperpigmentation occurring early in treatment, which continued to improve over time, as did wrinkling," said James Leyden, MD, Emeritus Professor, University of Pennsylvania Health Systems and KGL, Inc., and lead investigator. ELASTIderm(TM) Decolletage System is the only topical system backed by data from a 24-week clinical study that is designed to treat hyperpigmentation, including age spots and freckles, while reducing the appearance of fine lines and wrinkles. The System works by helping to replenish elasticity and build collagen in the chest and neck area. It is based on the Company's patented Penetrating Therapeutics(TM) technology that allows for greater penetration across the skin barrier to help stimulate elasticity and increase the overall resiliency of the skin. "Skin around the neck and chest is often overlooked in the anti-aging treatment process and our system can assist skin care professionals in providing the total rejuvenating results their patients want," said Steve Carlson, President and Chief Executive Officer of Obagi Medical Products. "We are proud that the ELASTIderm Decolletage System technology can provide patients such significant improvement in the reduction of fine lines and wrinkles, as well as effectively treating hyperpigmentation." Study Methodology Study subjects had a decolletage area with at least moderate levels of photodamage and at least moderate levels of mottled hyperpigmentation, fine wrinkling, or coarse wrinkling. All subjects applied the ELASTIderm(TM) Decolletage System to their entire decolletage twice daily for 24 weeks. Baseline assessments of the Investigator's Overall Integrated Assessment of Photodamage, the primary endpoint of the study, showed that all patients had very severe to moderate photodamage at the start of the study. By week 12, 53% of patients had only minimal to mild photodamage, increasing to 69% at week 24. At the start of the study, all patients had moderate to severe levels of hyperpigmentation associated with sun damage. By week 24, 79% of patients had minimal to no signs of hyperpigmentation. In addition, prior to treatment, all patients had moderate to severe levels of fine wrinkling. By week 24, 100% of patients had only mild to minimal levels of fine wrinkling. Overall, 95% of patients were "satisfied" or "very satisfied" with the overall improvement of their decolletage at week 24. About the ELASTIderm(TM) Decolletage System The ELASTIderm(TM) Decolletage System is a physician-dispensed skincare system that consists of two clinically proven topical skin treatments -- ELASTIderm Skin Lightening Complex and ELASTIderm Wrinkle Reducing Lotion. The ELASTIderm Skin Lightening Complex is formulated with 4% hydroquinone to aid in the gradual lightening of hyperpigmented skin conditions. The ELASTIderm Wrinkle Reducing Lotion is formulated with a proprietary bi-mineral complex with malonic acid that helps replenish elasticity and build collagen.   Stop TODAY for more information or visit,  www.OBAGI.com

 

September 9, 2008

American Laser Centers, the largest provider of laser hair removal and other noninvasive aesthetic services in the U.S., announces sponsorship of the STYLE360 show during New York Fashion Week.  STYLE360, from Sept. 7-10, serves as the alternative Fashion Week destination and showcases Spring and Summer 2009 runway shows of eight hand-picked fashion designers and two retailers. The audience will include national and international media, buyers, industry tastemakers, celebrities and socialites. All shows will take place at the historic Metropolitan Pavilion with a series of after-parties.

At the STYLE360 show, American Laser Centers will be demonstrating the latest craze on the beauty scene — VelaShape treatments. A favorite of models and fashion-forward celebrities, VelaShape is a non-invasive treatment that uses externally-applied energy to reduce the appearance of cellulite and measurably reduce circumference of the arms, thighs, love handles, abdomen or other designated treatment areas.  The first device to be FDA-approved for both cellulite reduction and circumferential reduction of the thighs,
VelaShape can make squeezing into the revealing, body-hugging and super-skinny
fashions that dominate the runway less challenging.

Click HERE to read more  from the skin care and beauty blog

 

 

Septemeber 1, 2008

The staff at the Sanctuary Spa is now proudly presenting the fact that we are offically the only owner's of the VelaShape skin tightening system in upstate New York. This world renowned technology is now available to you at the Sancturary Spa of Saratoga Springs. VelaShape is the only FDA-cleared treatment technology for controuting, shaping and slimming the body. Amazing results are availble in as few as 4 treatments.