ASRS 2023: GA in spotlight as Annexon presents ARCHER trial results highlighting potential of ANX007 as a differentiated treatment for disease

In presentations at the ASRS 41st Annual Meeting in Seattle, additional analyses support consistent protection from vision loss. (Image courtesy of Adobe Stock)

Annexon Inc. today presented results from the ongoing ARCHER trial in patients with geographic atrophy (GA), underscoring ANX007’s neuroprotective mechanism of action and demonstration of consistent protection from vision loss.

According to the company, data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists 2023 Annual Meeting taking place in Seattle.

Jeffrey S. Heier, MD, director of the Retina Service and Retina Research, Ophthalmic Consultants of Boston, and an investigator in ARCHER, highlighted some of the key points of the trial.

“Notwithstanding recent advances in the field of geographic atrophy, preservation of vision remains a central need for the millions of people living with GA around the world,” Heier said in the news release. “The results from ARCHER demonstrated dose and time dependent protection of visual function in GA across multiple measures. I am excited by the potential of ANX007 and its distinct neuroprotective mechanism of action, which could offer physicians a chance to preserve vision in a broad population of patients.”

Moreover, timeline data reported earlier this year showed that ANX007 demonstrated statistically significant, dose-dependent protection from vision loss in patients with GA, measured by best corrected visual acuity (BCVA) ≥15 letter loss, a widely accepted functional endpoint. Protection from vision loss was also shown in additional prespecified measures of visual function, including low luminance visual acuity (LLVA) and low luminance visual deficit (LLVD).

Annexon conducted additional analyses to further evaluate the effect of ANX007 treatment on BCVA and GA lesion area. Results presented today at ASRS included:

• Risk reduction for BCVA ≥15 letter loss was maintained in a more conservative analysis, in which events occurring at the last single-point visit were excluded.
  
• ANX007’s impact on BCVA ≥15 letter loss was consistent across patients’ baseline characteristics, including lesion size, lesion location, multifocality and others, and was not driven by any one patient subgroup.
  
• In addition to protection against ≥15 BCVA letter loss, ANX007’s impact on BCVA ≥10 letter loss and BCVA ≥20 letter loss demonstrated consistent, dose-dependent protection from vision loss.
  
• Mean change in BCVA at month 12 was supportive of protection of visual function in a dose-dependent manner.
• ANX007 was generally well-tolerated through month 12, with no increase in CNV rates between the treated and sham arms and no events of retinal vasculitis reported.

According to the company, the six-month off-treatment follow-up period of the ARCHER trial is ongoing, and Annexon plans to report final results following study conclusion.

“We're encouraged by the breadth and depth of the ARCHER data, which demonstrate robust, dose and time dependent preservation of vision loss in the broad patient population as measured by clinical assessments important to the healthcare community and patients,” Douglas Love, CEO of Annexon, said in the release. “Looking ahead, our priority is to advance ANX007 in GA as efficiently as possible, and we will meet with regulators later this year to determine the optimal path forward.”