RT001 – Novel Topical Formulation of Botulinum Toxin

RT001 (Botulinum Toxin Type A) Topical Gel for the Treatment of Lateral Canthal Lines

RT001, our lead product candidate, is a topical gel formulation of botulinum toxin type A in a proprietary, single-use administration apparatus. RT001 is applied to the skin and uses our patented TransMTS® peptide technology to enable delivery of botulinum toxin across the skin, eliminating the need for injections. Our initial focus is to develop and commercialize RT001 for indications where topical application provides a meaningful advantage over injectable administration. RT001 is currently in a Phase 3 clinical development program in the United States for the treatment of lateral canthal lines more commonly known as crow’s feet lines.

Crow’s Feet Lines — Our Lead Indication for RT001

The first indication we are pursuing for RT001 is for crow’s feet lines, the wrinkles in the outer corner of the eye area, which are commonly caused by aging. Consumers in general, and women in particular, believe that the eye area is the first place where they notice the signs of aging1. Consumers also believe that the perception of aging is affected by the quality of the skin. It appears that skin texture is a large need in the aesthetic market as a large segment of the anti-aging topical cosmeceutical market focused on improvement in skin texture and luminosity of the skin in the eye area despite only marginally effective product efficacy.
1 American Society for Dermatologic Surgery (ASDS) Consumer Survey on Cosmetic Dermatologic Procedures, 2013

Expanding the Market

Today’s culture places significant value on physical appearance, leading to widespread adoption of anti-aging and aesthetic treatments. The aesthetic market has grown dramatically in the United States, according to American Society for Aesthetic Plastic Surgery (ASAPS) annual statistics. In 2013, botulinum toxin remained the most frequently performed noninvasive procedure with a 15.6% year-over-year increase, according to ASAPS1. A strong consumer preference for non-surgical options and the increasing availability of effective alternatives has prompted adoption of non-surgical aesthetic procedures by a broader patient population. These trends have made non-surgical procedures the primary driver of growth in the aesthetic medicine market, accounting for 83.5% of the total number of procedures performed in 20131. Consumers spent more than $5 billion on non-surgical cosmetic procedures with physicians in 20131and injectable botulinum toxin treatments are the single largest cosmetic procedure in the United States and the rest of the world.

Even though aesthetic dermatology is the largest addressable target market for botulinum toxins there is still room to expand even further with the introduction of a topical formulation such as RT001. Market research2 suggests some current barriers to injectable botulinum toxin use include fear of frozen face and needle aversion, two issues that may be overcome with a topical option. According to the American Society for Dermatologic Surgery’s 2013 Consumer Survey on Cosmetic Dermatologic Procedures, more women are bothered by the wrinkles around their eyes (crow’s feet) than any other facial wrinkles, the target indication for RT001.3

Clinical Data

We have conducted thirteen clinical trials, with a total of over 1,400 subjects, with RT001 for the treatment of crow’s feet lines and are currently in Phase 3 clinical development. We have completed three Phase 2b clinical trials to evaluate RT001 for the treatment of moderate to severe crow’s feet lines. Two of these trials were double-blind, randomized, placebo-controlled trials. RT001 met the primary efficacy and all secondary endpoints in both trials, including demonstrating statistically significant and clinically meaningful reduction in crow’s feet lines that is visible to both physicians and patients.4 In all concentrations of peptide and botulinum toxin studied, RT001 was well tolerated. In particular, there were no systemic or local safety concerns or evidence of spread and no significant differences in the incidence of treatment-related adverse events.4 The majority of the adverse events were mild, transient and not related to the trial procedure or the study drug. No subjects discontinued from the trials due to adverse events. There was no evidence of the regional spread of botulinum toxin based on nerve and local muscle strength evaluations. There were no serious adverse events or systemic safety concerns related to study drug or treatment procedures or evidence of any systemic exposure based on clinical laboratory results and related evaluation.4
1 American Society for Aesthetic Plastic Surgery Statistics 2013
2 Revance Quantitative Consumer Primary Market Research, 2009 and 2012
3 American Society for Dermatologic Surgery (ASDS) Consumer Survey on Cosmetic Dermatologic Procedures, 2013
4 Revance data on file.