Reproxalap, a First-in-Class RASP Modulator, Under Review for Dry Eye Disease
The FDA has accepted the NDA for reproxalap for the treatment of dry eye disease.
The FDA has accepted the NDA for reproxalap for the treatment of dry eye disease.
Nyxol is a once-daily, preservative-free eye drop formulation of phentolamine mesylate.
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ADX-2191 (methotrexate injection) for the treatment of primary vitreoretinal lymphoma, a rare, aggressive retinal cancer. ADX-2191 is a preservative-free, intravitreal formulation of methotrexate designed to be vitreous-compatible. The application is supported by safety data from the phase 3…
The approval was based on data from the phase 3 DERBY and OAKS studies.
CSF-1 is a preservative-free solution that contains a combination of low-dose pilocarpine hydrochloride 0.4% and multifaceted vehicle.
Earlier this month, Global Pharma Healthcare had announced a nationwide recall of its artificial tear lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma.
The BLA is supported by data from the pivotal PULSAR and PHOTON trials.
The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling.
The approval was based on data from the phase 3 BUTTERFLEYE and FIREFLEYE trials.
The recalled lots of Artificial Tears Lubricant Eye Drops, 10mg in 1mL, ½ fl oz (15mL) bottles were distributed nationwide by EzriCare, LLC and Delsam Pharma.