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pp-191

Solution for injection

Dossier type
US CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Non-syndromic retinitis pigmentosa (RP) — vision restoration in patients with advanced photoreceptor loss Clinical stage: BLA under rolling submission to FDA (pivotal Phase 2/3 data filed) Modality: Biological (AAV2-based optogenetic gene therapy) Mechanism / Target: AAV2 vector delivering multi-characteristic opsin (MCO) gene to degenerate retinal bipolar and ganglion cells; MCO protein restores light-responsiveness independent of remaining photoreceptors; mutation-agnostic mechanism Route / form: Single intravitreal injection Differentiation: First-in-class optogenetic gene therapy for RP; FDA RMAT Designation; mutation-agnostic (treats all genetic forms of RP unlike gene-specific therapies); BLA under rolling FDA submission 2025; single-injection treatment;
Manufacturer #39331
US-based clinical-stage company developing Rx gene therapy for vision restoration in inherited retinal degenerative conditions. Proprietary, gene-agnostic, light-activated approach does not require residual photoreceptor activity. Advancing through clinical trials across multiple retinal indications.

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