A new drug, ANX007, could be the first to protect vision in people with dry age-related macular degeneration (AMD). In the Phase 2 ARCHER study, monthly injections of ANX007 cut the risk of significant vision loss by 72% and preserved key retinal structures essential for vision.
The developer of the drug, Annexon, plans on sharing results on it this week at AAO 2024, the 128th annual meeting of the American Academy of Ophthalmology. The data show that patients treated monthly with ANX007 had a significant level of vision protection in the aforementioned Phase 2 study. A Phase 3 is underway. Data from the study, known as ARCHER II, are expected in the second half of 2026.
The drug works by blocking the C1q molecule in the complement system, which is a key driver of neurodegeneration. ANX007 has received Fast Track status from the FDA and Priority Medicine (PRIME) designation in the EU, accelerating its development.
“The data is impressive, showing that ANX007 significantly protects against vision loss from geographic atrophy and helps preserve important retinal anatomy to achieve this,” said lead researcher Rahul N. Khurana, MD, of Northern California Retina-Vitreous Associates, in a press release. “This offers a lot of hope for our patients with geographic atrophy who are struggling for clinically meaningful treatments in practice.”
GA affects about 20% of legal blindness cases in North America, according to a 2020 paper. The condition causes regions of retinal cells to waste away and creating growing blind spots that impair daily activities like driving and reading.
ANX007 functions as a novel neuroprotective agent, targeting the C1q molecule in the complement system. The drug’s mechanism potentially prevents synapse loss, inflammation, and neuronal damage associated with vision loss in GA. In a clinical trial involving 161 patients, those receiving monthly 5 mg doses of ANX007 showed a 72% reduced risk of losing three or more lines of vision after one year of treatment (P = 0.006), while bi-monthly treatment reduced this risk by 48% (P = 0.064).
In addition, the treatment protected photoreceptors in the central fovea, reducing ellipsoid zone area loss by approximately 30% compared to the control group.
Filed Under: Ophthalmology
