Aldeyra All Set For Double Date With The FDA
Secures PDUFAs For Two Eye Products
The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.
You may also be interested in...
Data from a small Phase II study show that Aldeyra’s methotrexate formulation may address the underlying cause of 20%-30% of RP cases. The drug recently was denied US FDA approval in a rare ocular cancer.
Cequa arrives in India, almost four years post US debut with Sun deploying what has generally been perceived as the text-book launch approach of foreign firms in the country. Scrip delves into the market dynamics in a segment where AbbVie's blockbuster Restasis is well entrenched.
The company announced positive results for reproxalap from its Phase III INVIGORATE trial in allergic conjunctivitis, which may be a good sign for its dry eye disease studies.