Category

• Pipeline3

Organizations

• Bausch + Lomb64
• Alcon, Inc.43
• Eyes On Eyecare43
• American Optometric Association34
• Harrow28
• Glaukos26
• Regeneron22
• Topcon Healthcare22
• Aldeyra Therapeutics20
• Sight Sciences19

Tags

• FDA3
• Stargardt Disease3
• Gene Therapy3
• Retina3
• Clinical Trials2
• Inherited Retinal Disease1
• Injections1

• Organizations: AAVantgarde Bio✕

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Pipeline

FDA grants Orphan Drug designation to AAVantgarde's Stargardt gene therapy

Regulatory milestone is second designation for AAVB-039; includes tax credits for qualified clinical testing and, if approved, seven years of U.S. market exclusivity.

Pipeline

FDA grants Fast Track designation to AAVantgarde's Stargardt gene therapy

Status benefits clinical study of AAVB-039, an AAV8 intended to address the disease’s root cause by delivering the full-length ABCA4 gene via a single subretinal injection.

Pipeline

FDA OKs AAVantgarde's IND for Stargardt gene therapy trial

Clearance enables initiation of FIH study on AAVB-039, an AAV8 that delivers the full-length ABCA4 gene to address the disease’s root cause—enabling treatment for all types.