Aura Biosciences, Inc. has completed enrollment of 108 patients in the phase 3 trial evaluating belzupacap sarotalocan (bel-sar) as a frontline treatment for patients with early choroidal melanoma. Topline data for the 15-month primary endpoint are anticipated in the second half of 2027, the company said in a press release. 

According to Aura Biosciences, the ongoing CoMpass trial is the first registration-enabling study in patients with early choroidal melanoma. The global, randomized phase 3 trial is evaluating bel-sar vs sham control in the frontline setting under a Special Protocol Assessment (SPA) agreement with the US Food and Drug Administration (FDA). Aura previously received orphan drug designation from both the FDA and the European Medicines Agency, as well as fast track designation from the FDA for the treatment of early choroidal melanoma, the company said.

“Completing enrollment in our phase 3 CoMpass trial marks a significant milestone for Aura as we advance bel-sar toward a potential regulatory approval in early choroidal melanoma,” said Dr. Jill Hopkins, chief medical officer and president of R&D of Aura Biosciences, in the press release. “We believe bel-sar has the potential to become the first approved frontline, vision-preserving therapy for this disease, addressing a critical unmet need for patients who today often face treatment options that can result in irreversible vision loss. We are deeply grateful to the patients, investigators, and clinical sites participating in the CoMpass trial and look forward to reporting topline data in the second half of 2027.” RP