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Letybo®: A New FDA-Approved Neurotoxin for Glabellar Lines

Image of Glabellar Line Treatment at IAPAM's Aesthetic Medicine Symposium

Are you looking for a new option to help your patients smooth out frown lines? Letybo® might be just what you need. 

On February 29, 2024, the FDA approved Letybo® (letibotulinumtoxinA-wlbg) for the temporary improvement of moderate to severe glabellar lines in adult patients. 

As a medical provider, you want to offer your patients the best and most effective treatments. 

With so many neurotoxin options available, it can be challenging to know which one to choose. 

Letybo® offers a fresh alternative with impressive results that can benefit both you and your patients.

Developed and manufactured by Hugel, Inc., a South Korean biopharmaceutical company, Letybo® has already established a strong presence in the global aesthetics market. 

Now that it’s available in the United States, let’s explore what makes this neurotoxin special and how it can enhance your practice and your patients’ satisfaction.

Letybo® FDA Approval: What You Need to Know

The FDA approval of Letybo® on February 29, 2024, marks a significant milestone in aesthetic medicine. 

This approval was based on rigorous clinical trials that demonstrated both the safety and efficacy of Letybo® for treating glabellar lines – those pesky frown lines between the eyebrows. 

In the pivotal Phase III clinical trial, 355 subjects with moderate to severe glabellar frown lines received either 20 units of Letybo® or a placebo. 

The results were impressive. At 4 weeks after treatment:

  • 78.6% of patients showed significant improvement based on investigator assessment
  • 68.8% of patients reported noticeable improvement in their self-assessment
  • The composite responder rate was 64.7% for the Letybo® group compared to 0% in the placebo group

Patients noticed improvements as early as Day 2, with the median time to onset being just 3 days. 

The effects lasted an average of 127 days (about 4 months), which is comparable to other neurotoxins on the market.

The FDA approval specifically covers the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.

Like other botulinum toxins, Letybo® works by temporarily inhibiting acetylcholine release at the neuromuscular junction, reducing muscle activity and smoothing dynamic wrinkles.

Pros for Medical Providers Considering Letybo®

Adding Letybo® to your aesthetic practice offers several advantages:

Letybo® stands out for its high degree of purity and low protein load. 

These factors are associated with a reduced risk of immunogenicity, which may offer long-term benefits for patients who need repeat treatments. 

This is particularly valuable for your practice if you treat patients who have developed resistance to other neurotoxins.

Clinical studies have shown that Letybo® is as effective as onabotulinumtoxinA (Botox®) in treating glabellar lines and crow’s feet. 

This means you can confidently offer Letybo® knowing it delivers results similar to products you may already trust.

One notable attribute of Letybo® is its controlled diffusion pattern, which offers both efficacy and precision. 

Unlike some other neurotoxins known for broader spread, Letybo® demonstrates a focused area of activity. 

This makes it well-suited for precision work such as glabellar lines, giving you more control over the treatment outcome.

If you’re already comfortable with Botox®, you’ll find Letybo® reconstitution and handling techniques to be similar. 

This eases the transition into clinical use. Letybo® is supplied as a lyophilized powder in 50-unit and 100-unit vials, typically reconstituted with 0.9% preservative-free sodium chloride.

Patients report high satisfaction with Letybo®, citing natural results and minimal discomfort. 

In clinical studies, the product demonstrated a consistent safety and tolerability profile, which can lead to happy patients and repeat business.

Offering Letybo® can differentiate your practice in a competitive market. Being an early adopter of this newly FDA-approved treatment allows you to provide patients with the latest options in aesthetic medicine.

Cons for Medical Providers Considering Letybo®

While Letybo® offers many benefits, there are some considerations to keep in mind:

As a newer product in the U.S. market, Letybo® has less long-term data compared to more established neurotoxins like Botox®, which has been FDA-approved for cosmetic use since 2002. 

This may require more careful monitoring and follow-up with patients.

Even though Letybo® is similar to other neurotoxins, there may still be a learning curve to achieve optimal results. 

Understanding its specific diffusion properties and ideal dosing for different facial areas will take time and experience.

Introducing a new product means educating your patients about Letybo® and its benefits. Some patients may be hesitant to try a newer product when they’re familiar with established brands.

Letybo® contains 100 units per vial, with potency units that are specific to the proprietary assay used by Hugel, Inc. 

These units are not interchangeable with those of other botulinum toxin products. 

You’ll need to exercise caution when transitioning patients between products and avoid the temptation to use the same unit dosing across different neurotoxins.

If you’re transitioning patients from other neurotoxins to Letybo®, you’ll need to consider factors such as timing, dosing adjustments, and managing patient expectations during the switch.

Pros for Patients Considering Letybo®

Your patients will appreciate several benefits that Letybo® offers:

Patients can see results quickly, with effects typically beginning within 2-4 days and peaking at 1-2 weeks. 

This rapid onset of action means patients don’t have to wait long to enjoy their refreshed appearance.

Letybo® effects typically last approximately 3-4 months, depending on patient factors and injection technique. 

This duration is comparable to other neurotoxins on the market, providing good value for patients.

The precise diffusion pattern of Letybo® helps create natural-looking results. Patients report satisfaction with how they look after treatment, appreciating that they look refreshed rather than “frozen.”
The injection process is relatively comfortable, and post-treatment discomfort is minimal. Most patients can return to their normal activities immediately after treatment.

Letybo® demonstrated a favorable safety profile in clinical trials, with no serious adverse events related to treatment reported. 

The incidence of treatment-related adverse effects remained low and comparable to other agents.

Having another FDA-approved neurotoxin on the market gives patients more options for their aesthetic treatments. 

This is especially beneficial for patients who may not have responded well to other products or who are looking for alternatives.

Cons for Patients Considering Letybo®

Patients should also be aware of potential drawbacks:
Like all neurotoxins, Letybo® provides temporary results. Patients will need repeat treatments every 3-4 months to maintain their desired appearance.
While generally well-tolerated, Letybo® can cause side effects similar to other neurotoxins, including:
  • Localized pain or tenderness at the injection site
  • Erythema, edema, or bruising
  • Headache Mild ptosis or asymmetry, depending on injection technique
Letybo® is contraindicated in patients with:
  • Hypersensitivity to any botulinum toxin preparation or its excipients
  • Presence of infection at proposed injection sites
  • Certain neuromuscular disorders
As with all aesthetic treatments, there is a cost involved with Letybo® injections. Patients will need to consider if the investment is worthwhile for them, especially given the temporary nature of the results.

Letybo® Clinical Use Overview

For optimal results with Letybo®, consider these clinical guidelines:

A commonly recommended dilution is 2.5 mL per 100 units, providing a standard concentration of 4 units per 0.1 mL. 

For glabellar lines, a typical starting dose is 20 units of Letybo®, divided evenly across 5 injection points: one in the procerus and two in each corrugator supercilii muscle.

For best results:
  • Use a 30G or 32G needle for optimal control and minimal trauma
  • Inject perpendicular to the skin surface for deeper targets like the glabellar muscles
  • Always aspirate in high-risk areas to avoid intravascular injection
  • Use smooth, consistent pressure to ensure accurate dosing and minimize bruising
Letybo® is suitable for adult patients seeking non-surgical treatment for moderate to severe glabellar lines. Ideal candidates include those:
  • With realistic expectations
  • New to neurotoxin treatment Interested in a high-purity product
  • Seeking rapid results with minimal downtime
As with all neurotoxins, thorough patient consultation and assessment are essential to achieve optimal outcomes and maintain safety.

Conclusion

Letybo® represents an exciting new option in the world of aesthetic medicine. With its FDA approval, proven efficacy, and favorable safety profile, it offers both medical providers and patients a valuable alternative for treating glabellar lines. 

For medical providers, Letybo® provides an opportunity to expand your treatment options and potentially attract new patients. 

Its high purity, precise diffusion pattern, and ease of use make it a welcome addition to your aesthetic toolkit. 

For patients, Letybo® offers quick, natural-looking results with minimal downtime and a duration of effect comparable to other neurotoxins on the market. 

As with any aesthetic treatment, success with Letybo® depends on proper technique, appropriate patient selection, and realistic expectations. 

By understanding both the benefits and limitations of this new neurotoxin, you can make informed decisions about incorporating it into your practice. 

Want to learn more about Letybo® injection techniques and get certified? 

Check out our comprehensive Botox® & Letybo® training programs designed specifically for medical professionals like you. 

Enhance your skills, expand your practice, and give your patients the results they desire with Letybo®.

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