Clinical Trial Success Uncertainty: Developing gene therapies for inherited retinal diseases is complex, and Opus Genetics' product candidates may not demonstrate sufficient safety or efficacy in clinical trials to achieve regulatory approval.

Regulatory Approval Risk: Opus Genetics' ability to commercialize its gene therapies depends on obtaining necessary regulatory approvals from health authorities, which is a lengthy, uncertain, and costly process that may not be successful.

Insufficient Funding Risk: Developing and commercializing gene therapies is capital-intensive, and Opus Genetics may require significant additional funding that may not be available on favorable terms, potentially hindering its research, development, and operational activities.