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Wire · operational-macro

FDA clears Opus Genetics' IND for RDH12-LCA gene therapy

Published

28 October 2026

Topic

operational-macro

◆ Sectors

Biotech

◆ Geography

United States

◆ Source

Read at glance.eyesoneyecare.com →

◆ Verified

Fusion42 · 28 October 2026 · Fusion42 review

Opus Genetics has received FDA clearance for its IND application of OPGx-RDH12, a gene therapy targeting RDH12-associated Leber congenital amaurosis, an inherited retinal disease causing early childhood blindness. This investigational AAV-based therapy aims to deliver a functional RDH12 gene to retinal photoreceptors, backed by supportive preclinical safety and efficacy data.

This Wire brief sits within Fusion42's coverage of Biotech.

◆ ◆ The Wire takeaway

FDA clearance for OPGx-RDH12 opens a path to clinical trials in rare retinal disease treatment. You can now plan clinical development and fundraising with this regulatory green light in place.

◆ Coverage

1 source · 28 Oct 2026

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◆ Topics

Biotechgene-therapyfda-approvalinherited-retinal-diseaserdh12-lcaclinical-trials