Choroidal melanoma (CM) is the most common primary intraocular cancer in adults, with an incidence of approximately 11,000 patients per year in the United States and EU. CM comprises approximately 90% of all cases of uveal melanoma, which include tumors of the choroid, ciliary body and iris.

It is estimated that 96% of choroidal melanoma patients are diagnosed early without clinical evidence of metastatic disease. However, treatment options for early choroidal melanoma are severely limited: patients and their physicians must choose between radiotherapy, which arrests tumor growth but is associated with high morbidity and vision loss, or “watch and wait”, which delays vision loss but increases the risk of developing metastatic disease.

In a Phase 2 dose escalation clinical trial in patients with early choroidal melanoma, bel-sar achieved an 80% tumor control rate and 90% visual actuity preservation rate at 12 months among patients who received a therapeutic dose. Bel-sar also demonstrated a favorable safety profile, with only mild (Grade 1) adverse events reported. These results provide evidence of the potentially transformative profile of bel-sar for patients living with early choroidal melanoma.

We are evaluating the safety and efficacy of bel-sar in an ongoing global Phase 3 CoMpass trial for the first-line treatment of early choroidal melanoma. This clinical trial is being conducted under a Special Protocol Assessment with the US Food and Drug Association.