The table provided is a review of notable updates that occurred in February 2023 for investigational products in development.
News and Features
February 2023 Notable Drug Approvals
The product is used as an anti-inflammatory intended to relieve ocular irritation and/or swelling.
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…
Brimonidine Tartrate Ophthalmic Solution is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.
The BLA is supported by data from the pivotal PULSAR and PHOTON trials.
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.
CSF-1 is a preservative-free solution that contains a combination of low-dose pilocarpine hydrochloride 0.4% and multifaceted vehicle.
The approval was based on data from the phase 3 DERBY and OAKS studies.
ACP is an investigational complement C5 inhibitor that is designed to decrease the activation of inflammasomes and the formation of membrane attack complex.
Nyxol is a once-daily, preservative-free eye drop formulation of phentolamine mesylate.
The approval was based on data from the phase 3 BUTTERFLEYE and FIREFLEYE trials.
EA-2353 is a novel, small molecule designed to selectively activate endogenous retinal stem and progenitor cells.
Anatomic improvement, but no improvement in visual acuity, reported with aflibercept given for 4 years versus sham.
The FDA has accepted the NDA for reproxalap for the treatment of dry eye disease.
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.
The Centers for Disease Control and Prevention (CDC) is urging health care providers and patients to immediately discontinue use of EzriCare Artificial Tears as the Agency is currently investigating its link to multiple different infection types, including eye infections. From May 17, 2022 to January 19, 2023, the CDC, alongside state and local health departments,…
Cumulative incidence of retinopathy was higher with increasing dose of hydroxychloroquine
ADX-2191 is a preservative-free, intravitreal formulation of methotrexate designed to be vitreous-compatible.
Iyuzeh is a preservative-free prostaglandin F2α analogue.