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.
Diagnosis & Disease Information
Nyxol Ophthalmic Solution Under Review for Reversal of Mydriasis
Nyxol is a once-daily, preservative-free eye drop formulation of phentolamine mesylate.
Intravitreal Methotrexate Under Review for Primary Vitreoretinal Lymphoma
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…
Syfovre Approved for Geographic Atrophy Secondary to AMD
The approval was based on data from the phase 3 DERBY and OAKS studies.
FDA to Review Novel Corrective Eye Drop Candidate for Presbyopia
CSF-1 is a preservative-free solution that contains a combination of low-dose pilocarpine hydrochloride 0.4% and multifaceted vehicle.
FDA Adds OTC Eye Ointment to List of Possibly Contaminated Products
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.
Aflibercept 8mg Under Review for Wet AMD, Diabetic Eye Disease
The BLA is supported by data from the pivotal PULSAR and PHOTON trials.
Sterility Issues Prompt Recall of Another Ophthalmic Product
The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling.
Eylea Approved for Preterm Infants With Retinopathy of Prematurity
The approval was based on data from the phase 3 BUTTERFLEYE and FIREFLEYE trials.
Artificial Tears Recalled Due to Possible Infection Risk
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.
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