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A melanoma that arises from the structures of the eye or ocular adnexa.
Biomarker and diagnostic research for ocular melanoma has been reported in the published literature.
No approved treatments are currently available for ocular melanoma. An additional 1 compound holds orphan drug designation.
While no drugs are FDA-approved specifically for ocular melanoma, some of the following designated compounds may be used off-label in clinical practice. Treatment decisions should be made in consultation with a specialist familiar with this condition.
The following drugs have received orphan drug designation from the FDA for ocular melanoma. Orphan designation reflects regulatory interest and does not indicate approval for treatment.
Brand Name | Generic Name | Sponsor |
|---|
11 clinical trials registered, 3 recruiting. Interventions under study include drug therapy, other interventions, medical devices, and biologic therapy. Pipeline includes 2 PHASE3, 3 PHASE2, 3 PHASE1. Research is sponsored by a mix of industry and academic institutions.
NCT ID | Title | Phase | Sponsor | Status |
|---|---|---|---|---|
[NCT06940739](https://clinicaltrials.gov/study/NCT06940739) |
Data assembled from 4 of 12 sources · Last updated Oct 3, 2026, 11:43 AM UTC
Patient Advocacy Groups (PAGs) provide support, resources, and community for patients and caregivers.
Designated
Exclusivity End |
|---|
Designation Status |
|---|
rose bengal disodium | rose bengal disodium | Provectus BioPharmaceuticals, Inc. | 2019 | — | Designated |
Gene therapy approaches for ocular melanoma have been reported in the published literature.
11 trials found
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel |
PHASE1 |
Iovance Biotherapeutics, Inc. |
RECRUITING |
[NCT06970236](https://clinicaltrials.gov/study/NCT06970236) | Resistance Exercise in Patients With Ocular Melanoma | NA | University of Valencia | RECRUITING |
[NCT07421739](https://clinicaltrials.gov/study/NCT07421739) | Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects | — | Aura Biosciences | RECRUITING |
197 publications have been identified in PubMed for ocular melanoma. Research spans Review / Meta-Analysis (31%), Basic Science / Preclinical (24%), and Epidemiology / Natural History (16%).
Research Type | Count | % of Total |
|---|---|---|
Research summaries | 60 | 31% |
Laboratory research | 47 | 24% |
Disease patterns and progression | 32 | 16% |
Patient case studies | 17 | 9% |
Clinical study results | 17 | 9% |
Testing and diagnosis research | 16 | 8% |
New treatment approaches | 5 | 3% |
Other research | 2 | 1% |
Singh D (2026). [PMID: 35201711](https://pubmed.ncbi.nlm.nih.gov/35201711/). *Unknown Journal*. [Gene Therapy / Novel Therapeutics]
Hiong A (2026). [PMID: 41633932](https://pubmed.ncbi.nlm.nih.gov/41633932/). *Clin Exp Ophthalmol*. [Review / Meta-Analysis]
Xi Y (2026). [PMID: 41708863](https://pubmed.ncbi.nlm.nih.gov/41708863/). *Nature*. [Basic Science / Preclinical]
Bui NT (2026). [PMID: 42143553](https://pubmed.ncbi.nlm.nih.gov/42143553/). *Ultrasonics*. [Diagnostic / Biomarker]
Kaštelan S (2026). [PMID: 41751395](https://pubmed.ncbi.nlm.nih.gov/41751395/). *Curr Issues Mol Biol*. [Review / Meta-Analysis]
Fu Y (2026). [PMID: 41713838](https://pubmed.ncbi.nlm.nih.gov/41713838/). *Cancer Lett*. [Gene Therapy / Novel Therapeutics]
Lee H (2026). [PMID: 41564770](https://pubmed.ncbi.nlm.nih.gov/41564770/). *J Hazard Mater*. [Review / Meta-Analysis]
Dave N (2026). [PMID: 42128079](https://pubmed.ncbi.nlm.nih.gov/42128079/). *Am J Ophthalmol*. [Clinical Trial Publication]
Ninmer EK (2026). [PMID: 41775435](https://pubmed.ncbi.nlm.nih.gov/41775435/). *J Immunother Cancer*. [Clinical Trial Publication]
Mukundan A (2026). [PMID: 41316839](https://pubmed.ncbi.nlm.nih.gov/41316839/). *Ocul Immunol Inflamm*. [Review / Meta-Analysis]