Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, paired with the BF-RhodoLED lamp series, has received an approval by the US Food and Drug Administration (FDA) approval for superficial basal cell carcinoma (sBCC) in adults.¹ The approval makes photodynamic therapy (PDT) the first modality of its kind cleared to treat a skin cancer in the US.¹˒²

Basal cell carcinoma is diagnosed in an estimated 3.6 million patients annually in the US, and superficial subtypes account for approximately 540,000 to 720,000 of those cases each year.¹ Lesions are often multiple and located on the trunk and extremities, and non-surgical, tissue-sparing options for this population have remained limited.¹ Mohs surgery, electrodesiccation and curettage, and topical imiquimod have served as the primary alternatives to date.

In the pivotal phase 3 trial, 66% of patients treated with Ameluz PDT achieved composite clinical and histological clearance of the main target lesion at 12 weeks (95/145), versus 5% with placebo-PDT (2/42).¹ Histological clearance reached 76% with Ameluz PDT versus 19% with placebo-PDT, and complete clinical clearance of all target lesions reached 83% versus 21%.¹ Application-site reactions were the most common adverse events reported, consistent with the known safety profile of Ameluz PDT.¹

For dermatologists, the data offer a tissue-sparing alternative for lesions in areas where surgery carries added risk. Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego, California, treats skin cancer and has followed PDT development for years. In this Q&A summary of his interview, he discusses how the approval reshapes patient counseling and how the efficacy data stack up against surgical benchmarks.

HCPLive: What does it mean for dermatology to have the first FDA-approved photodynamic therapy regimen for skin cancer?

Neal Bhatia, MD: Well, for me, who's kind of a PDT nut, I'm actually very thrilled. It's nice to see yet another advanced use for photodynamic therapy. Red light PDT has been established with us for decades, brought to us with 16% methyl ALA, and now with 10% ALA in the gel, we've really got some good options. I'm actually very excited to see how photodynamic therapy can work on basal cell especially, but it's been used off-label with both red and blue light for different kinds of tumors.

We've had lots of different things in the hopper for photodynamic therapy, but the mainstays being actinic keratosis, acne, and some other indications for cutaneous T-cell lymphoma with different light. For me, I am always a fan of non-surgical alternatives. Mohs surgery is still the gold standard. Electrodesiccation and curettage is an easy treatment option for superficial basal cell, as has topical imiquimod for years, among several others. But I think of elderly patients, hard-to-treat areas like the pretibial surfaces, behind the ears, near the eyelids, areas where surgery may not be the easiest option.

I don't want to ever say best option, but the easiest option. Patients on anticoagulants, patients on oxygen, there's always ways to think about where I can use something that doesn't involve surgery but still has efficacy for tumor clearance. This is where we now have a really good option in front of us. There's a smaller light, the BF-RhodoLED, and there's going to be a bigger panel light, so there are a lot of options for using red light. The opportunities here are pretty rich for us.

HCPLive: How might this approval change how you counsel superficial BCC patients who would otherwise go straight to surgery?

Neal Bhatia, MD: I think where we once were just saying we have to cut this out, now we take into account whether there's another way to minimize scarring, which photodynamic therapy is good at. PDT also treats the innocent skin, if you will, the photoaged skin around the tumor rather than just the tumor itself. A lot of the studies with red light as well as blue light have treated this photodamaged surrounding skin, so there's a bit of an inadvertent field effect, but we're getting treatment of the surrounding skin as well as the tumor, so that's also a plus.

There's also a benefit to think about with multiple cycles, are we getting the treatment response we want? As we saw in the study, 66% of patients cleared over 12 weeks, compared to 5% in the placebo plus light arm, so that was a really good opportunity to show the value of the photosensitizing element. The other part of the equation is I look at the number of patients diagnosed with superficial basal cell, but also the numbers who are early in that stage. If we get patients treated for actinic keratoses and find an incidental basal cell that clears, that's also an approved treatment now, so there's an upside there.

There are a lot of good ways to position PDT now. In terms of office settings, whether a private equity clinic, a freestanding practice, or an institution, incorporation of a light device, whether blue or red, photodynamic therapy has to be part of a practice to really treat these areas and serve as a chemoprevention strategy too.

HCPLive: How do you weigh a 66% composite complete response rate against the reliability of Mohs surgery?

Neal Bhatia, MD: Mohs surgery being the gold standard of surgical procedures for skin cancer, it's hard to match 98% efficacy, and I wouldn't say I'd rather do this than that. I'd approach it more from the candidacy of the patient, their health, the location of the tumor, and how many surgeries they've had. There are a lot of factors in that respect. I'd also think about a younger person in a very cosmetically sensitive area: if they don't want surgery, how viable an option is this?

PDT, if anything, improves the texture of the skin rather than leaving a surgical scar, so we may see a cosmetic benefit from not having surgery. But I wouldn't be the one to say stop the surgeries, you don't need Mohs anymore. I'd say we now have a better option than cryotherapy, and something we can use in conjunction with imiquimod if needed. I look at the opportunity to use photodynamic therapy as a treatment modality, and with this data, it's very strong. It's a very useful tool for us to consider putting into motion in the practice.

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 17, 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 17, 2026. Accessed September 16, 2026. https://www.hcplive.com/view/ameluz-treatment-becomes-first-fda-approved-pdt-skin-cancer.