Annexon Inc. (ANNX) today announced that it has achieved a key clinical milestone by completing enrollment in its phase III trial of Vonaprument for dry age-related macular degeneration with geographic atrophy.
The phase III trial, dubbed ARCHER II, has enrolled more than 630 patients who will be randomized 2:1 to receive a monthly dose of Vonaprument or a sham procedure. The primary endpoint is the prevention of a loss of 15 or more letters in best corrected visual acuity (BCVA), which represents three lines on the standard Early Treatment of Diabetic Retinopathy Study (ETDRS) eye chart.
Vonaprument previously demonstrated significant vision preservation based upon best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) in a phase II trial.
The company is on track to report topline pivotal data from the phase III ARCHER II study in the second half of 2026.
If all goes according to plan, Vonaprument could be the first approved treatment in Europe and the U.S. for dry AMD with geographic atrophy based on protection of visual acuity and structural measures, according to the company.
Commenting on the developments, Douglas Love, president and chief executive officer of Annexon, said, "Achieving and surpassing our enrollment goal ahead of schedule in ARCHER II highlights the strong interest for a treatment that can help patients preserve their vision."
ANNX has traded in a range of $1.28 to $7.85 in the last 1 year. The stock closed yesterday's trading at $2.48, up 4.64%.
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