Neal Bhatia, MD

Full 52-week results from a phase 3 open-label extension trial show denifanstat, an oral fatty acid synthase (FASN) inhibitor, maintained acne control with a favorable long-term safety profile in patients with moderate to severe acne vulgaris, according to Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego. The data, from the ASC40-304 extension study conducted by Ascletis BioScience in China, were presented as a poster today at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna, Austria, building on the 

 reported last year. Bhatia discussed the findings in an interview with 

Denifanstat Sustains Acne Control Through 52 Weeks, With Neal Bhatia, MD

Denifanstat, also known as ASC40 in China, is not an antibiotic or a retinoid; instead, it inhibits fatty acid synthase, the enzyme central to sebum production.

 "It's more effective to turn off the faucet than mop up the mess," Bhatia said, explaining that by limiting sebum, the drug also curbs the inflammatory mediators and the food source for Cutibacterium acnes that sebum helps sustain.

The extension study enrolled 239 patients in its safety population, 115 who remained on continuous denifanstat and 124 who switched from placebo to denifanstat after the 12-week double-blind period.¹ Bhatia noted the 2 groups diverged somewhat in baseline disease severity entering the extension, with the placebo-switch group starting with more severe disease. Treatment success, defined as an Investigator's Global Assessment score of 0 or 1 with at least a 2-point improvement, was achieved by 57.8% of patients who remained on denifanstat throughout and 55.6% of those who switched from placebo, reflecting continued improvement in both groups over the full 52 weeks.¹ Bhatia said reductions were seen not just in inflammatory lesion counts but in comedone counts as well, and that efficacy generally plateaued between weeks 24 and 36.

On safety, Bhatia said the extension data addressed his top concerns as an investigator directly. "There were very few serious adverse events. Only two that were counted in one of the groups, and nobody discontinued the drug for any adverse events," he said. 

The most frequently reported treatment-related events, dry skin, dry eye, and skin desquamation, were low-frequency and did not lead to treatment discontinuation.¹ Bhatia said the absence of retinoid-like or antibiotic-like adverse effects reflects the drug's targeted mechanism, and that no laboratory monitoring is required, a meaningful distinction from options such as spironolactone.

Looking ahead, Bhatia said the 52-week safety data support long-term use of denifanstat as a maintenance therapy alongside topical treatment, potentially reducing reliance on antibiotics and, in some patients, spironolactone, without positioning the drug as a replacement for isotretinoin. He said remaining questions include optimal use in combination regimens, tapering strategies, and dosing flexibility, which he expects to be addressed as the drug moves toward a planned US phase 3 program.

Bhatia’s disclosures include Asclestis, Sagimet, Sanofi/Regeneron, Sun Pharmaceutical Industries, Soligenix, Takeda, Zerigo Health, and more.

Denifanstat for moderate-to-severe acne vulgaris: results from an open-label, multicenter, phase III extension study. Poster presented at: European Academy of Dermatology and Venereology (EADV) Congress 2026; September 30-October 3, 2026; Vienna, Austria.

Sagimet Biosciences Inc. Sagimet announces positive full 52-week results from license partner Ascletis' phase 3 open-label extension clinical trial of denifanstat in acne presented at EADV 2026. Published September 30, 2026. 

https://www.globenewswire.com/news-release/2026/09/30/3371663/0/en/sagimet-announces-positive-full-52-week-results-from-license-partner-ascletis-phase-3-open-label-extension-clinical-trial-of-denifanstat-in-acne-presented-at-eadv-2026.html

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Bhatia discusses 52-week extension data showing denifanstat sustained acne control with a favorable long-term safety profile, presented at EADV 2026.

Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, paired with the BF-RhodoLED lamp series, has received an approval by the 

 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.

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

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.

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

 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.

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

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.

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

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

Articles

Neal Bhatia, MD, weighs the newly approved Ameluz PDT regimen for sBCC against Mohs surgery, citing its 66% composite response rate.

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

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 

 on how the treatment fits into practice, how easily it might be adopted, and what questions remain before routine use.

Where Does Ameluz PDT Fit Alongside Mohs Surgery?

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.

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. 

Smith T. Ameluz treatment becomes first FDA-approved PDT for skin cancer. HCPLive. Published September 14, 2026. Accessed September 16, 2026. 

Where does Ameluz PDT fit next to Mohs surgery for skin cancer? Neal Bhatia, MD, on candidacy, adoption, and open questions.

The FDA has approved Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, plus the BF-RhodoLED lamp series for superficial basal cell carcinoma in adults, the first and only photodynamic therapy indicated for a skin cancer in the US.

In the supporting phase 3 trial, 66% of patients on Ameluz PDT (95 of 145) achieved complete clinical and histological response of the main target lesion at 12 weeks, compared with 5% on placebo-PDT (2 of 42).

Neal Bhatia, MD, says the approval gives dermatologists a nonsurgical option for patients with lesions in difficult-to-treat locations or surgical risk factors, using the same gel and lamp already deployed for actinic keratosis.

 approved Biofrontera's supplemental new drug application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, implemented with the BF-RhodoLED lamp series, for the treatment of 

 in adults, making it the first photodynamic therapy (PDT) regimen the agency has cleared for a skin cancer.¹

Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego and chief medical editor of Practical Dermatology, discussed the September 14 approval with 

. Bhatia was asked about both the approval’s significance and some of the data surrounding the decision.

What the FDA's Approval of Ameluz PDT Means for Skin Cancer

The approval, granted a decade after Ameluz's original actinic keratosis (AK) indication, makes it the only topical PDT in the United States indicated for both a precancerous lesion and a skin malignancy.¹ It was supported by a multicenter, randomized, double-blind, vehicle-controlled phase 3 trial in 187 adults with histologically confirmed sBCC, in which 66% of patients treated with Ameluz PDT (95 of 145) achieved complete clinical and histological response of the main target lesion at 12 weeks, compared with 5% (2 of 42) on placebo-PDT.¹ 

 on the approval covers the regulatory background and trial data in more depth.²

"I don't want to ever say best option, but the easiest option,” Bhatia said. “People on anticoagulants, people on oxygen, there's always ways to think about, OK, where can I use something that doesn't involve surgery but still has efficacy of the tumor clearance? And I think this is where now we have a really good option in front of us.”

Bhatia said the indication gives dermatologists another nonsurgical route for patients whose lesions sit in difficult-to-treat locations, such as the pretibial surfaces, behind the ears, or near the eyelids, or who are poor surgical candidates because of anticoagulant or oxygen therapy. Mohs surgery remains the gold standard, he noted, alongside established options such as electrodesiccation and curettage and topical imiquimod.

He noted red-light PDT also treats the photo-damaged skin surrounding a tumor in addition to the lesion itself, a field effect he sees as an added benefit over surgical excision alone. Bhatia said he expects photodynamic therapy, delivered through the smaller BF-RhodoLED unit or the larger panel light, to become a standard fixture across dermatology practice settings.

Editor’s note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

What does FDA approval of Ameluz PDT for superficial BCC mean for dermatology? Neal Bhatia, MD, weighs in on the first-of-its-kind decision.