What’s New in Injectables?

This year is shaping up to be yet another blockbuster for new injectables. As we all know, the injectable market is an ever-evolving space, with each year bringing new products as well as new indications to the US market.

TOXINS

In the neuromodulator realm, letibotulinumtoxinA-wlbg (Letybo, Hugel America, Inc.) was approved by the US Food and Drug Administration (FDA) in 2024 for the treatment of glabellar lines. It is already available in several countries and is the leading neuromodulator in South Korea. While the mechanism of action remains the same as the other neuromodulators on the market, Letybo may differ at least from the standpoint of its molecular makeup and the use of proteins meant to stabilize the botulinum toxin. Letybo contains fewer of the complexing proteins that are known to be a potential target for antibodies that contribute to resistance. Duration seems to be in line with the others, so it will only be a matter of time until we see the impact that this product may have on the established neuromodulators within our market.

Another neuromodulator with anticipated US approval next year is relabotulinumtoxinA (Relfydess™, Galderma). This is the first ready-to-use liquid neuromodulator, created with a proprietary technology called PEARL™ that is designed to preserve the integrity of the molecule, making it highly active and complex-free. It is approved in Australia, the UK, and 14 other European markets for two indications—frown lines and crow’s feet. This could be attractive to many as Relfydess™ is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.

OnabotulinumtoxinA (Botox, Allergan Aesthetics) recently received a new indication from the FDA for the treatment of platysmal bands. In the study, they rated the severity of the bands, which directed the dosage that was needed to treat. While most neuromodulators are frequently and safely injected in sites that are not FDA approved, it is always reassuring to see a standardized study evaluating the effectiveness and proper usage of the product. There is an ongoing study looking at Botox for the treatment of masseter hypertrophy that we should expect to see results for later this year.

FILLERS

The portfolio of dermal fillers that we have will expand this year. Evolus announced the FDA approval for two new hyaluronic acid (HA) injectable gels, Evolysse™ Form and Evolysse™ Smooth. This is first new HA technology to launch in a decade, and the only HA injectable gel that utilizes a cold technology called Cold-X™ (Symatese), which is designed to preserve the natural structure of the HA molecule. The idea behind the cold technology is that it may better preserve the hyaluronic acid chain and use less 1,4-Butanediol diglycidyl ether (BDDE) as a cross-linking agent to get the same gel dynamics. Evolysse™ Form and Evolysse™ Smooth were evaluated in a head-to-head study with Restylane®-L, and both products met the primary endpoint of non-inferiority.¹

Currently approved in Canada and Brazil, Restylane® SHAYPE™ (Galderma) is a new HA injectable designed for augmenting the chin region. This will be their firmest HA injectable available, designed for deep injection onto bone and providing a bone-mimicking effect to shape the lower face. Galderma plans to bring this new technology to the United States as soon as possible.

The next generation of injectables in the US market will be the hybrid injectable fillers. These include a blend of HA with products such as calcium hydroxylapatite (CaHA) and elastin, just to name a few. The idea behind these is to use an HA primarily for volume and lifting while combining this with another product like a biostimulator for improved skin architecture and firmness. HArmonyCa (Allergan Aesthetics) is a hybrid injectable filler that combines CaHA microspheres suspended in HA gel. The matrix of HA and CaHA provides structural support for facial soft-tissue augmentation and supports fibroblast proliferation. Neocollagenesis leads to tissue thickening and improved skin architecture, which increases skin firmness and soft-tissue quality and results in a sustained lifting effect over time. The hybrids carry the potential to optimize what we are doing with injectables in our aesthetic practices. This is especially relevant as we have seen a switch in gears from using pure volumizing products in most people to a regenerative, more holistic approach to the aging face. This would be the first of its kind in the US market.

As with any new technology, understanding the rheology and mechanism of action of each product within the syringe is critical for producing safe and effective results. For example, a recent article by Braz et al discusses in their recommendation the importance of HArmonyCa being injected in small volumes and distributed homogenously in the area of treatment.² I think that this will require a greater level of education for the injectable company to extend to physicians and injectors who plan on using this product to minimize potential adverse events.

I always find it exciting to have new fillers on the market, even if there are similarities amongst many of them. This creates healthy competition for the injectable companies as well as pushes them for continued innovation in our aesthetic space.

1. Dayan SH. Efficacy of a Novel HA Dermal Filler for Nasolabial Fold Correction: Prospective, Controlled, Double Blind Pivotal Trial Results. Research presented at: Music City SCALE (Symposium for Cosmetic Advances & Laser Education); May 17; Nashville, TN.

2. Braz A, de Paula Eduardo CC, Pierce A, Grond A, Kutikov A, Nakab L. A Novel Hybrid Injectable for Soft-tissue Augmentation: Analysis of Data and Practical Experience. Plast Reconstr Surg Glob Open. 2024;12(9):e6190. Published 2024 Sep 19. doi:10.1097/GOX.0000000000006190.