December 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in December 2022 for investigational products in development.
Diagnosis & Disease Information
Intravitreal Methotrexate NDA Submitted for Primary Vitreoretinal Lymphoma
ADX-2191 is a preservative-free, intravitreal formulation of methotrexate designed to be vitreous-compatible.
LASIK Should Carry Warnings of Possible Complications, FDA Says
New guidance says complications can include dry eyes, double vision, difficulty with night driving, chronic eye pain
October 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in October 2022 for investigational products in development.
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 Drafts Guidance on Patient Labeling Information for LASIK Devices
Guidance offers content and formatting suggestions for patient information for laser-assisted in situ keratomileusis devices
FDA Approves Small Aperture Intraocular Lens for Cataract Patients
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.
Kimmtrak Approved for Unresectable or Metastatic Uveal Melanoma
The approval was based on data from the phase 2 IMCgp100-202 trial that assessed Kimmtrak in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma.
