A new study shows geographic atrophy (GA) patients treated monthly with an investigational drug cut their risk of vision loss by 72%. As well, significant areas of the retina that are critical for good vision were protected.
“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 Dr Rahul N. Khurana, of Northern California Retina-Vitreous Associates in the United Sates.1
“This offers a lot of hope for our patients with GA who are struggling for clinically meaningful treatments in practice.”
Novel Neuroprotective Agent
ANX007 is a novel neuroprotective agent that is injected into the eye. It works by blocking a part of the immune system known as the complement system, specifically the immune molecule C1q in the complement pathway. C1q is thought to be a key driver of neurodegeneration. The hope is that by blocking C1q it might be possible to prevent the synapse loss, inflammation and neuronal damage that results in vision loss from GA.
In a Phase 2 clinical trial, 161 patients were randomised to receive either a 5 mg dose of ANX007 every month, every other month, or sham treatment. After one year of treatment, the risk of losing three lines of vision or more, as measured by an eye chart, was reduced by 72% in patients treated monthly, and by 48% in patients treated every other month.
After one year of treatment, ANX007 reduced ellipsoid zone area loss by approximately 30% in patients treated every month or every other month, compared with patients who received sham injections.
Although the US Food and Drug Administration (FDA) last year approved two new drugs that can help slow disease progression, there are currently no approved treatments that can protect vision from this devastating condition.
Fast Track Status
Based on this and other data, the FDA has granted the treatment Fast Track status, and the European Union has given it Priority Medicine (PRIME) designation to speed up investigation of ANX007.
A global, randomised, sham-controlled Phase 3 trial of ANX007 is currently underway, with topline data expected in the second half of 2026.
Reference
- American Academy of Ophthalmology, Promising new drug may be the first to protect vision in people with dry AMD (news release, 21 Oct 2024) available at: aao.org/newsroom/news-releases/detail/promising-new-drug-may-be-first-to-protect-vision [accessed 30 Oct 2024].
