How does photodynamic therapy treat skin cancer?

A topical gel (Ameluz) is applied and preferentially absorbed by cancer cells, which convert it into a light-sensitive compound. Exposing the area to red light then activates it, generating reactive oxygen that destroys the abnormal cells while largely sparing healthy tissue — a non-surgical approach.

Why is this approval significant?

It is the first photodynamic therapy cleared to treat a skin cancer (rather than only precancerous lesions), offering a non-surgical option for superficial basal cell carcinoma — the most common cancer in the U.S., with about 3.6 million new cases a year.

How well does it work?

In the supporting trial, 83% of treated patients had complete clinical clearance of all target lesions versus 21% on placebo, with histological clearance of the main lesion in 76% versus 19%. Treatment choice still depends on tumor type, size and location.

FDA Approves Ameluz Red-Light PDT for Superficial Basal Cell Carcinoma

A red-light photodynamic treatment with Biofrontera’s Ameluz gel is now approved for superficial basal cell carcinoma — the first photodynamic therapy okayed for any skin cancer.

The FDA has approved a light-activated therapy for superficial basal cell carcinoma (sBCC) — the first time photodynamic therapy (PDT) has been cleared to treat any skin cancer. It offers a non-surgical option for the most common cancer in the United States.

The approval

Announced on September 14, 2026, the approval covers Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used together with red-light PDT delivered by the BF-RhodoLED lamp, for adults with superficial basal cell carcinoma. Biofrontera, the maker, secured the clearance ahead of the FDA’s expected decision deadline later in the month.

How photodynamic therapy works

PDT is an elegant two-step idea. First, the Ameluz gel is applied to the lesion, where cancerous cells preferentially absorb it and convert it into a light-sensitive compound. Then the area is exposed to a specific wavelength of red light, which activates that compound and generates reactive oxygen that destroys the abnormal cells — while largely sparing surrounding healthy tissue. The result is a targeted, non-surgical treatment that can leave better cosmetic outcomes than cutting, an advantage on visible areas like the face.

Why basal cell carcinoma matters

Basal cell carcinoma is the most frequently diagnosed malignancy in the U.S., with an estimated 3.6 million new cases a year. It rarely spreads or kills, but it is enormously common, and its usual treatment — surgical excision — can be invasive and leave scars, especially given how often these cancers appear on the face and neck. A well-tolerated, non-surgical alternative for the superficial subtype addresses a genuine everyday need in dermatology.

The evidence

In the supporting trial, the treatment substantially outperformed placebo: histological clearance of the main target lesions was 76% versus 19%, and 83% of treated patients had complete clinical clearance of all target lesions, versus 21% with placebo. Those are strong clearance rates for a topical, light-based approach.

Why it matters

Beyond the individual product, the approval is a category milestone: it establishes photodynamic therapy as a legitimate, FDA-sanctioned tool against skin cancer, not just precancerous lesions (its prior use). For patients with superficial BCC who want to avoid surgery, it expands the menu of options. As always, treatment choice depends on the tumor’s type, size and location, and is a decision for a dermatologist. This is regulatory news, not medical advice.

This article is for general information only and is not medical advice. Consult a qualified healthcare professional for any medical decisions.

FDA Clears the First Light-Activated Therapy for the Most Common Skin Cancer