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
Miscellaneous Ocular Agents
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.
Intravitreal Gene Therapy Fast Tracked for X-Linked Retinitis Pigmentosa
4D-125 is a gene therapy candidate designed to deliver a functional copy of the RPGR gene to photoreceptors in the retina.
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.
Growing Evidence Links Pentosan Polysulfate Sodium, Maculopathy
Specific retinal conditions proportionately more common for PPS users versus users of other interstitial cystitis, bladder pain drugs
New Drug Product: Susvimo
This slideshow shows drug information for Susvimo. Click here for the complete Susvimo monograph.
Susvimo Approved for Wet Age-Related Macular Degeneration
Susvimo delivers ranibizumab via ocular implant, which is surgically inserted into the eye during a one-time, outpatient procedure and refilled every 6 months.
First Biosimilar to Lucentis Gets FDA Approval
The approval of Byooviz was based on a review of evidence demonstrating a high degree of similarity to the reference product.
