By Steve Yoelin, MD; Mary Gardner, CLP, MBA, P.ENG; and Jean Carruthers, MD, FRCSC, FRC (OPHTH)
Wrinkle-smoothing injections of botulinum toxin type A top the list for the most requested cosmetic procedure year after year, largely because of their strong efficacy and safety profile.
All toxins, without exception, risk undesirable patient outcomes, which is particularly worrisome due to patients’ high expectations for natural-looking results, the high price point of these procedures, and the high levels of competition among both toxin injectors and toxin manufacturers. The risk of undesirable patient outcomes is reduced by more experienced injectors; however, it can still happen even in the most skilled hands. For example, unforeseen anatomical irregularities could result in the inadvertent spread of toxin, regardless of injectors’ level of experience. The most common undesirable outcomes in facial rejuvenation include eyelid or eyebrow ptosis, elevated or “Spock” brow, and lip misalignment. While hyaluronic acid fillers can be dissolved using the enzyme hyaluronidase, toxins have no such commercially available remedy, so injectors often must resort to using toxins sparingly.
Although undesirable patient outcomes and side effects diminish over weeks or months, the prominence of these side effects on patients’ faces, the significant prices that patients pay for toxin procedures, and the risk of unfavorable injector reviews render this slow option unacceptable. A product capable of reversing undesirable toxin outcomes is desperately needed among patients, injectors, and toxin manufacturers alike. Prospective neurotoxin patients would be more comfortable knowing that adverse events from neurotoxins, although rare, could be quickly reversed.
What Is ReViVox?
DelNova’s ReViVox has the potential be the first-ever product to reverse the effects of botulinum neurotoxins. The active pharmaceutical ingredient in ReViVox indirectly elevates levels of the neurotransmitter acetylcholine by breaking down the enzyme that would otherwise degrade acetylcholine, thereby counteracting the blockage of acetylcholine that is caused by toxins.
Unlike a toxin, which is a biologic or a large molecule, ReViVox is a small molecule, which can be more affordably and efficiently manufactured. The drug substance has already been indicated as an infusion for the reversal of neuromuscular blockade in anesthesia and as an oral pill to treat an autoimmune condition involving muscle weakness. Studies have evaluated the active drug in ReViVox as an intramuscular injection, which is the same way in which neurotoxins are injected.
DelNova has been granted patents for ReViVox and has shown proof of concept in a Phase 1 human study. The company is raising funds to proceed under the abbreviated 505(b)(2) pathway for regulatory approval. This approach applies to drugs that already have approval for other indications. After fundraising is complete, DelNova will submit our application for FDA approval in two to three years.
In the Phase 1 human study, a group of patients received a toxin treatment to reduce frown lines. After the toxin achieved full effect and patients exhibited a limited ability to frown, injection of ReViVox into the same area restored most patients’ ability to frown and move their glabellar-region muscles, indicating reversal of the neurotoxin within five to 15 minutes. These results demonstrate that ReViVox can reverse undesirable outcomes of neurotoxin treatments.
Growing the Market
Penetration of aesthetic neurotoxin procedures among the U.S. population remains very low, and companies in the industry, from toxin manufacturers to injectable providers and clinics, seek growth through the addition of new patients and new injectors. Unfortunately, the industry currently lacks a solution for the quick reversal of neurotoxins to reassure prospective patients and injectors, as well as to exceed patient expectations during and after treatments. In a survey of practitioners (dermatologists, plastic surgeons, nurses, and doctors from other medical specialties), respondents overwhelmingly shared that a product such as ReViVox would benefit the aesthetics industry. A reversal agent for botulinum toxins is overdue in the medical aesthetics industry.
ABOUT THE AUTHORS
Steve Yoelin, MD, is an Ophthalmologist at Steve Yoelin MD Medical Associates in Newport Beach, CA.
Mary Gardner, CLP, MBA, P.ENG, is the CEO & Founder of DelNova, Inc.
Jean Carruthers, MD, FRCSC, FRC (OPHTH), is a Clinical Professor in the Department of Ophthalmology at the University of British Columbia in Vancouver, Canada.
DISCLOSURES
Steve Yoelin, MD, reports grants and stock options with DelNova, Inc. and serves as an advisor and Chief Medical Strategist for DelNova, Inc.
Mary Gardner, CLP, MBA, P.ENG, is the Chief Executive Officer and Founder of Del Nova, Inc and has an equity stake in the company.
Jean Carruthers, MD, FRCSC, FRC (OPHTH), serves as a scientific advisor and has stock options with DelNova, Inc.
