Evolus Achieves Major Milestone with FDA Clearance for Evolysse Injectable Hyaluronic Acid Gel Portfolio

New HA Dermal Filler Technology to Hit U.S. Market in Q2 2025, Positioning Evolus Products as Industry Game-Changer

Evolus, Inc. (NASDAQ: EOLS), a performance beauty innovator, has secured FDA approval for Evolysse™ Form and Evolysse™ Smooth, marking a pivotal shift in the company’s growth trajectory. This dual approval represents the first significant technological advancement in hyaluronic acid dermal fillers in ten years and signals Evolus’ transformation from a single-product enterprise into a diversified aesthetic powerhouse.

Market Expansion and Strategic Significance

The regulatory clearance expands Evolus’ addressable market substantially—by 78%—bringing the total opportunity to approximately $6 billion. The company’s leadership has outlined an ambitious vision: achieving $700 million in net revenue and maintaining non-GAAP operating margins above 20% by 2028. This trajectory underscores how the Evolysse collection positions Evolus products as critical revenue drivers for the coming years.

“This approval transforms our business outlook,” explained David Moatazedi, Evolus’ President and CEO. “We’re transitioning from a focused operator to a multi-product innovator. The synergy between our existing neurotoxin business and these new dermal filler offerings creates significant operational leverage and consumer value.”

The Innovation Behind Evolysse Products

Developed in partnership with Symatese, the Evolysse collection leverages proprietary Cold-X™ technology—a breakthrough designed to preserve the natural architecture of hyaluronic acid molecules. This technical advancement delivers extended durability and more authentic aesthetic outcomes compared to conventional approaches.

The injectable HA formulations offer practitioners flexibility in application depth, enabling customized treatment protocols. One of the most extensive clinical evaluation programs for injectable HA technology underpinned these approvals, involving over 2,000 patients globally across multiple study sites.

Clinical Evidence and Market Entry Timeline

The U.S. nasolabial fold pivotal trial enrolled 140 patients in a rigorous, double-blind, split-face design. Each Evolysse formulation—Form and Smooth—met the primary non-inferiority endpoint in head-to-head comparison studies. Investigators reported impressive safety profiles, robust efficacy measures, and high patient satisfaction with durability and visual outcomes.

Dr. Rui Avelar, Evolus’ Chief Medical Officer, emphasized the company’s commitment to quality: “These approvals underscore our dedication to advancing patient safety and clinical effectiveness. Cold-X™ technology delivers a differentiated dermal filler experience, giving practitioners precision tools for personalized treatment.”

Beyond the Q2 2025 U.S. launch of Form and Smooth, Evolus products in the Evolysse line will expand further. Evolysse™ Sculpt is scheduled for 2026 entry, followed by Evolysse™ Lips in 2027, creating a complete portfolio addressing diverse clinical needs.

Operational Synergies and Market Position

The commercial rollout will leverage Evolus’ established cash-pay distribution infrastructure and digital engagement capabilities. Integration with the company’s fast-growing neurotoxin business creates meaningful operational efficiencies and cross-selling opportunities, amplifying market penetration and customer lifetime value.

This regulatory victory positions Evolus products not merely as new offerings but as catalysts for sustained growth and market leadership in performance aesthetics.