Scaling and commercial preparation for an optogenetic vision-restoring gene therapy, highlighting manufacturing partnerships and regulatory readiness.
Key Takeaways
- MCO-010 reported positive RESTORE Phase 2b/3 results and holds FDA Fast Track, Orphan, and RMAT designations
- Rolling submission to the FDA is underway as the company prepares for Phase 3
- Catalent will provide commercial-compliant packaging, distribution, and packaging validation to support the BLA