- Biofrontera AG BFRA has provided an update on two submissions to the FDA, enabling the simultaneous use of up to three tubes of Ameluz per photodynamic therapy (PDT) on the one hand while seeking approval for a larger red-light lamp BF-RhodoLED XL, on the other.
- About the approval process of BF-RhodoLED, the FDA has confirmed that the data are sufficient for the submission and that the evaluation process will be initiated.
- Regarding the other submission, the agency did not express any concerns related to efficacy/results. However, it asked to amend the product information, limiting the use to one tube of Ameluz per treatment. The FDA recommended the submission of expanded safety data.
- The FDA agreed with the proposal to observe systemic and local side effects during treatment with three tubes of Ameluz in 100 patients. This safety study will start in the second half of 2021.
- About the potential expansion of the Ameluz approval to moderate and severe acne in the U.S., the Company has finalized Phase 2b trial design.
- Ameluz incubation times of one and three hours will be compared with placebo in 126 participants. The trial will start in the second half of 2021.
- Comparable to the European approval expansion of Ameluz for the treatment of mild and moderate actinic keratoses on the extremities and trunk/neck with PDT, the Company is currently preparing a Phase 3 trial. Enrollment will start in the first half of 2022.
- Price Action: BFRA shares are up 0.13% at $6.52 during the market trading session on the last check Tuesday.
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