Todd Brady, Aldeyra Therapeutics CEO

Aldeyra to run an­oth­er tri­al for its dry eye dis­ease drug as part of re­sub­mis­sion plans

Aldeyra Ther­a­peu­tics is plan­ning to re­sub­mit an NDA for its dry eye dis­ease drug in the sec­ond half of this year, though it’ll have to run an­oth­er clin­i­cal tri­al.

The com­pa­ny said Thurs­day that the re­sub­mis­sion for re­prox­alap is con­tin­gent on pos­i­tive da­ta from an­oth­er dry eye cham­ber clin­i­cal tri­al that is set to start by June. Once Aldeyra re­sub­mits the NDA, the FDA’s re­view pe­ri­od is ex­pect­ed to be six months, rep­re­sent­ing about a 12-month de­lay to the orig­i­nal launch plans.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.