Nyxol Ophthalmic Solution Under Review for Reversal of Mydriasis
Nyxol is a once-daily, preservative-free eye drop formulation of phentolamine mesylate.
Diagnosis & Disease Information
Aflibercept Granted Priority Review for Retinopathy of Prematurity
The sBLA is supported by data from the phase 3 FIREFLEYE and BUTTERFLEYE trials that evaluated the efficacy and safety aflibercept in infants with ROP.
Iheezo Ophthalmic Gel Approved for Ocular Surface Anesthesia
Iheezo is a sterile, preservative-free, single-patient use, ophthalmic gel preparation.
FDA Approves Small Aperture Intraocular Lens for Cataracts
The device is intended for primary implantation in the capsular bag, in the nondominant eye, after the fellow eye has already undergone successful implantation of a monofocal or monofocal toric IOL that is targeted for emmetropia.
Aflibercept 16-Week Dosing Regimen for Diabetic Retinopathy Under Review
The sBLA is supported by data from the phase 3 PANORAMA trial and the NIH-sponsored Protocol W trial.
Visomitin Gets Orphan Drug Status for Leber Hereditary Optic Neuropathy
Visomitin is a cardiolipin peroxidation inhibitor designed to sustain and restore mitochondrial function and interrupt apoptosis in mitochondrial conditions.
Tebentafusp Gets Priority Review for Metastatic Uveal Melanoma
The application is supported by data from the phase 2 IMCgp100-202 trial that assessed tebentafusp in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma.
Intravitreal Methotrexate Gets Orphan Drug Status for Retinitis Pigmentosa
The FDA has granted Orphan Drug designation to ADX-2191 (methotrexate for intravitreal injection) for the treatment of retinitis pigmentosa.
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