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.
The table provided is a review of notable updates that occurred in December 2022 for investigational products in development.
ADX-2191 is a preservative-free, intravitreal formulation of methotrexate designed to be vitreous-compatible.
New guidance says complications can include dry eyes, double vision, difficulty with night driving, chronic eye pain
The table provided is a review of notable updates that occurred in October 2022 for investigational products in development.
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 is a sterile, preservative-free, single-patient use, ophthalmic gel preparation.
Guidance offers content and formatting suggestions for patient information for laser-assisted in situ keratomileusis devices
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.
The sBLA is supported by data from the phase 3 PANORAMA trial and the NIH-sponsored Protocol W trial.
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.