Aura Announces Global Phase 3 Trial Design with Suprachoroidal Route of Administration of Belzupacap Sarotalocan in Early-Stage Choroidal Melanoma

Aura Biosciences announced that it has initiated startup activities for the global phase 3 trial. After presenting positive interim data at the American Academy of Ophthalmology from its ongoing phase 2 trial, Aura has aligned with regulatory agencies and finalized the design of the global phase 3 trial. The trial will evaluate the efficacy and safety of belzupacap sarotalocan (bel-sar) with suprachoroidal administration, for the first-line treatment of early-stage choroidal melanoma (CM).

“Finalizing the study design and selecting the optimal route of administration for the phase 3 trial are key milestones in progressing towards a potential approval for bel-sar as a first-line vision preserving therapy in patients with early-stage choroidal melanoma,” Dr. Cadmus Rich, Chief Medical Officer of Aura Biosciences, said in a company news release. “We are pleased to have aligned with regulatory agencies on the overall phase 3 trial design, including the primary and key secondary endpoints. We remain focused on improving the standard of care for patients with early-stage choroidal melanoma, a life-threatening disease that has no approved therapies.”

The phase 3 trial has a three arm randomized and masked design, where the primary analysis will compare bel-sar to sham. Aura is planning to enroll approximately 75 adult patients with eary-stage CM, including patients with indeterminte lesions and small choroidal melanoma. Patients will be enrolled with documented growth as an enrichment strategy intended to increase the efficiency of the trial which will include an adaptive design to further increase the probability of success.