Avulux has received De Novo marketing authorisation from the FDA, establishing the first recognised device classification for a lens designed to manage light sensitivity associated with migraine. The company said the decision defines how Avulux may be used and creates a new FDA-recognised category of precision optical filter.

The De Novo pathway is used for first-of-its-kind medical devices with no comparable products previously authorised in the US. Avulux said the new classification gives patients, eye care providers and commercial partners clarity on what the lens is and who it can help.

Avulux is indicated to block light at 480nm and 590nm while allowing the remaining visible spectrum through, reducing the impact of light sensitivity in patients aged 12 and older diagnosed with episodic migraine. It is worn like ordinary eyeglasses and can be made with or without a prescription.

“For a long time, light sensitivity was seen as just a symptom of migraine. That thinking has changed,” said Dr Charles Posternack, Co-Founder and Chief Executive Officer of Avulux. “There is growing recognition that light sensitivity is a serious medical concern in its own right. This authorisation gives patients and providers a clear, FDA-recognised option designed specifically to manage the impact of light in those with migraine, one we hope will soon become the standard of medical care in this population.”

Light sensitivity affects nearly 90% of people living with migraine and can force individuals away from work, family and daily life. Until now, there has been no FDA-authorised option designed specifically to manage this symptom.

“Migraines in children are often underdiagnosed and undertreated, despite their profound impact on development, education and overall well-being,” explained Juan Espinoza, MD, Director and Principal Investigator of the Consortium for Technology & Innovation in Pediatrics. “At CTIP, we are committed to supporting innovations like Avulux that offer non-invasive and effective solutions to improve
the lives of paediatric patients.”

Nxera Pharma has announced that its partner Neurocrine Biosciences has
received FDA IND acceptance for a phase 2 study of NBI-1117567 for Alzheimer’s
cognition. Nxera will receive a US$10 million milestone payment, recognised in
full as revenue in Q3 FY2026.

NBI-1117567 is an investigational oral muscarinic M1-preferring agonist discovered using Nxera’s NxWave drug discovery platform. Neurocrine is advancing the programme under a multiprogramme collaboration with Nxera.

Christopher Cargill, President and CEO of Nxera Pharma, commented: “We
are delighted to report that NBI-’567 has become the third compound in the muscarinic agonist portfolio to receive approval to proceed to a phase 2 study. This follows direclidine (NBI-1117568), the first NxWave-designed molecule to advance into a phase 3 study, and NBI-1117570, which is currently in phase 2.”

He added: “Alzheimer’s cognition remains an area of significant unmet medical need globally, including in Japan, and we believe NBI-’567 has the potential to contribute meaningfully to improving outcomes for patients. We look forward to
sharing further updates on progress across the muscarinic agonist portfolio.”

NBI-1117567 is a selective muscarinic M1/M4 agonist. Muscarinic receptor play a key role in neurotransmission, with M1 considered a potential drug target for cognition and M4 for psychosis.