Roughly a month after receiving its second US Food and Drug Administration complete response letter, Aldeyra said on 5 May that it believes new Phase II data will meet the agency’s requirements and intends to refile a new drug application for reproxalap in dry eye disease in mid-2025. If it can get to market, reproxalap could be highly competitive in dry eye disease.
Key Takeaways
- Aldeyra obtains positive Phase III dry eye disease symptom data and hopes to refile an NDA for reproxalap, already the subject of two FDA complete response letters.
On a 6 May analyst call, CEO Todd Brady said the reactive aldehyde species (RASP)-modulating eye drop demonstrated superiority to...