Where Does Ameluz PDT Fit Alongside Mohs Surgery?

After the US Food and Drug Administration’s (FDA) September 14 approval of Ameluz photodynamic therapy (PDT) was announced for superficial basal cell carcinoma (sBCC), Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego and chief medical editor of Practical Dermatology, spoke with HCPLive on how the treatment fits into practice, how easily it might be adopted, and what questions remain before routine use.1,2

Bhatia said Mohs surgery remains the gold standard for skin cancer, with efficacy around 98% that PDT's 66% composite complete response rate cannot match head-to-head. Rather than positioning PDT as a replacement, he frames the choice around patient candidacy: tumor location, overall health, number of prior surgeries, whether lesions are multiple, and how much a patient values avoiding a surgical scar, particularly younger patients in cosmetically sensitive areas.

"PDT, if anything, it improves the texture of the skin rather than leaving what a surgical scar might do. So, if anything, we may see a benefit from the cosmetic end as a result of not having surgery," Bhatia expressed.

He called PDT a stronger option than cryotherapy and one that could be used alongside imiquimod, another approved sBCC treatment, rather than in competition with Mohs.

On adoption, Bhatia said the regimen's use of equipment already installed in many practices should ease the path to incorporating it, and could let non-Mohs clinicians run PDT sessions in parallel with surgical cases. He described the treatment itself as largely hands-off once the gel is applied: patients incubate, then undergo light treatment, requiring little additional staff time.

Looking ahead, Bhatia said 6-month and 1-year recurrence data, along with longer-term cosmetic outcomes and reimbursement clarity, are the questions he expects the field to prioritize. He also raised possible protocol refinements worth studying, including more aggressive debridement or curettage before treatment, use of occlusion, adjusted incubation times, warming the skin to improve protoporphyrin IX conversion, and whether post-treatment management for sBCC should differ from the approach used for actinic keratosis.

Editor’s note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Bhatia had no relevant financial disclosures of note.

References

1. Biofrontera Inc. Biofrontera announces FDA approval of Ameluz Red Light PDT for the treatment of superficial basal cell carcinoma. Published September 14, 2026. Accessed September 14, 2026. https://www.globenewswire.com/news-release/2026/09/14/3361199/0/en/biofrontera-announces-fda-approval-of-ameluz-red-light-pdt-for-the-treatment-of-superficial-basal-cell-carcinoma.html.

2. Smith T. Ameluz treatment becomes first FDA-approved PDT for skin cancer. HCPLive. Published September 14, 2026. Accessed September 16, 2026. https://www.hcplive.com/view/ameluz-treatment-becomes-first-fda-approved-pdt-skin-cancer