Pinneberg, Germany, April 23rd 2025. photonamic GmbH & Co KG (Photonamic) are pleased to announce that our U.S. subsidiary, NX Development Corporation (NXDC), has successfully completed its phase 3 study (MEN-301) and comfortably met the primary endpoint, investigating 5-ALA as an adjunct in meningioma patients undergoing fluorescence-guided surgery. Meningiomas are the most common type of primary brain tumor. Under the trade names Gleolan® in the United States and Gliolan® in Europe, 5-ALA has primarily been used in the approved indication of fluorescence-guided resections of malignant gliomas (WHO grade III and IV) in combination with a surgical microscope and blue light source. Meanwhile, experience has demonstrated that meningiomas may also show fluorescence. This was the motivation leading to the initiation of the MEN-301 study, conducted primarily at centers in the United States, as well as centers in Germany and Austria.
