Aldeyra suffers rejection in rare eye cancer due to 'lack of substantial evidence' but seeks use under Expanded Access
The FDA has rejected Aldeyra’s bid for approval in a rare, aggressive type of eye cancer for which the company didn’t conduct any clinical trials.
Aldeyra announced on Wednesday that it received a complete response letter for its candidate ADX-2191 in primary vitreoretinal lymphoma (PVRL), a sometimes misdiagnosed cancer that can present as blurred or lost vision, floaters, red eye and sensitivity to light. The FDA noted a “lack of substantial evidence of effectiveness” in Aldeyra’s application, as well as “a lack of adequate and well-controlled investigations,” according to the company.
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