FDA Approves Zerviate for Allergic Conjunctivitis
Zerviate is the first topical ocular formulation of cetirizine.
Ocular Allergy/Inflammation
Teprotumumab for Thyroid-Associated Ophthalmopathy
Smith, TJ et al. “Teprotumumab for Thyroid-Associated Ophthalmopathy”. DOI: 10.1056/NEJMoa1614949.
Tocilizumab Assessed for JIA-Associated Uveitis
Rapid and maintained improvement in all ocular parameters was seen with tocilizumab treatment.
Dextenza NDA Resubmission Accepted for Post-Surgical Ocular Pain
The NDA for Dextenza was resubmitted in January 2017 following a Complete Response Letter that was issued in July 2016 due to concerns with deficiencies in manufacturing processes and controls.
Dextenza NDA Resubmitted for Post-Surgery Ocular Pain
Ocular has announced that it has resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Dextenza (dexamethasone insert) 0.4mg, to treat ocular pain after ophthalmic surgery.
Links Between Preeclampsia and Later Retinal Disease Examined
Preeclampsia is associated with increased risk of maternal retinal disease, especially traction detachments, retinal breaks, and diabetic retinopathy, according to a study published in the January issue of Obstetrics & Gynecology.
Results Released for Investigational Uveitis Therapy
Santen has announced positive results from two Phase 3 trials of sirolimus intravitreal injection 440µg (Opsiria) for patients with non-infectious uveitis of the posterior segment.
Ocufen Eye Drops No Longer Available
The Food and Drug Administration (FDA) has posted a discontinuation notice for Ocufen (flurbiprofen sodium ophthalmic solution; Allergan) 0.03% and its authorized generic.
Anti-VEGF Agents Efficacy Compared in Diabetic Macular Edema
A post-hoc analysis of a randomized clinical trial comparing three anti-vascular endothelial growth factor (VEGF) agents, found that intravitreous aflibercept was associated with the greatest improvement in visual acuity (VA) over 2 years, for patients with diabetic macular edema (DME).
