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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