> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Reflection Biotechnologies Orphan Drug Designation
- URL: https://www.fdaweb.com/reflection-biotechnologies-orphan-drug-designation/
- Published: 2018-08-28T12:00:00.000Z
- Updated: 2026-09-15T00:28:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142219

FDA has granted Reflection Biotechnologies an orphan drug designation for RBIO-101, an *adeno-associated virus* gene therapy product for treating Bietti's Crystalline Dystrophy (BCD), a rare retinal degeneration. “In BCD, progressive atrophy and degeneration of the retinal pigment epithelium (RPE) lead to symptoms similar to those of other forms of retinal degeneration, including retinitis pigmentosa (RP),” the company says. Reflection Bio and Columbia University researcher **Stephen H. Tsang** are driving research and development efforts for the BCD gene therapy candidate. “The RBIO-101 preclinical data from Dr. Tsang’s lab support the clinical translation for patients with BCD,” the company says.