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Start Date

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Category

• Pipeline2

Organizations

• Bausch + Lomb67
• Eyes On Eyecare53
• Alcon, Inc.47
• American Optometric Association38
• Harrow31
• Glaukos28
• Regeneron25
• Topcon Healthcare25
• Aldeyra Therapeutics21
• Sight Sciences19

Tags

• FDA2
• Leber Hereditary Optic Neuropathy (lhon)2
• Clinical Trials1
• Retina1

• Organizations: Chiesi Group✕

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Pipeline

FDA rejects Chiesi Group's NDA for LHON oral drug

Agency issues company response letter citing a need for additional clinical data, further demonstrating idebenone’s safety and effectiveness.

Pipeline

FDA grants priority review for Chiesi's LHON therapeutic

Approved by the EMA as Raxone, idebenone could become the first and only clinically proven treatment to address the underlying cause of LHON.