This article is part of Ophthalmology Advisor’s Focus on Retina coverage from the 2021 meeting of the American Academy of Ophthalmology, held in New Orleans from November 12 to 15, 2021. The team at Ophthalmology Advisor will be reporting on a variety of the research presented by the retinal experts at the AAO. Check back for more from the AAO 2021 Meeting.


Adults with choroidal melanoma (CM) treated with AU-011 had a significant reduction in tumor growth after 1 year of treatment, according to researchers. Data from the Phase 1b/2 trial was presented by Carol Shields, MD, at the American Academy of Ophthalmology 2021 meeting, held in New Orleans from November 12-15.

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The study included 15 adults, a subset from a larger study comprised of 56 participants, with CM who were treated with 3 weekly doses of the highest regimen of intravitreal AU-011 and laser. Study participants were treated with up to 2 cycles. They were then evaluated for efficacy at 12 months. 

Researchers reported a statistically significant reduction in tumor growth rate over 1 year after treatment (-0.445 mm/year, P =.018). In addition, 60% of patients (9/15) achieved tumor control at 12 months. Most patients (73%) maintained visual acuity (defined as a loss of best corrected visual acuity of fewer than 15 letters) at 12 months. 

The majority of patients (14/15) were at high risk for vision loss with radiotherapy (tumors ≤3 mm from the foveola). However, among all 56 treated patients, serious adverse events were rare, with only 2 patients with juxtafoveal tumors developing treatment-related vision loss. In general, adverse events, such as intraocular inflammation and intraocular pressure increase, were transient and treatable in most patients. 

“AU-011 may offer a vision-preserving therapy for first-line treatment of CM,” concluded the researchers. 

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Shields CL. A Phase 1b/2 trial of AU-011, a first-in-class targeted therapy for the treatment of choroidal melanoma via intravitreal administration. Paper presented at: The American Academy of Ophthalmology 2021 Annual Meeting; November 12-15, 2021; New Orleans. Abstract PA054.