Aldeyra touts first part of PhI­II for rare eye dis­ease but ques­tions re­main as FDA meet­ing ap­proach­es

An 18-year-old biotech is grow­ing up with some pos­i­tive da­ta out of the first part of a Phase III study in a rare eye dis­ease with no ap­proved ther­a­pies. But go­ing for­ward with the study in a sim­i­lar fash­ion will be “dif­fi­cult, if not im­pos­si­ble,” the com­pa­ny’s CEO said on an in­vestor call.

The biotech, Aldeyra Ther­a­peu­tics, said that its in­trav­it­re­al­ly-in­ject­ed drug was su­pe­ri­or to a his­tor­i­cal con­trol in pre­vent­ing reti­nal de­tach­ment, an emer­gency event in which back-of-the-eye tis­sue sep­a­rates from blood ves­sels and caus­es de­ple­tion of oxy­gen and nour­ish­ment. The p-val­ue came in at 0.024, the Lex­ing­ton, MA, biotech said Thurs­day morn­ing.

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