RECELL system hits repigmentation endpoints in vitiligo

The RECELL system was successful in repigmenting skin in patients with vitiligo, Avita Medical announced in a press release.

A randomized, controlled trial used RECELL, a technology device and platform that harnesses the regenerative properties of the skin to create Spray-On Skin cells, to treat one portion of depigmented skin and compared repigmentation with a control in another portion of depigmented skin in the same patient. The control portion received narrowband ultraviolet-B phototherapy.

After 6 months, an expert central review committee found 56% of patients treated with RECELL had repigmentation of more than 50% of the treated area, compared with 12% of the control treatments.

Repigmentation of at least 80% was achieved by 36% of the RECELL treatment areas, compared with 0% of the control treatments.

“Vitiligo often has a severe impact on quality of life and is a therapeutic area within which there have been very limited treatment options. We are excited by our topline data, as we are now closer to our goal of providing patients with a durable, clinically meaningful, one-time treatment for repigmentation,” Mike Perry, DVM, PhD, Avita Medical CEO, said in the release. “RECELL has the potential to address the unmet medical need for an estimated 1.3 million people in the U.S. who suffer from stable vitiligo, and further, we envision a potential opportunity for RECELL as part of a multi-modal treatment plan for patients achieving stability with JAK inhibitor treatment.”

The company plans to submit for FDA approval by the end of 2022, according to the release.