Ocular Allergy/Inflammation

NDA Submitted for Durasert 3-Year Implant for Posterior Segment Uveitis

By January 08, 2018

The NDA submission was supported by data from two Phase 3 studies that met the primary efficacy endpoint of prevention of recurrence of uveitis at 6 months of follow-up (P<0.001).

FDA to Review New Treatment for Post-Op Ocular Pain, Inflammation

By January 08, 2018

If approved Inveltys would become the first twice-daily post-surgical topical treatment; all current treatments are approved for four-times-a-day dosing.

Nonpowder gun-related pediatric eye injuries on the rise

January 08, 2018

Pediatric eye injuries related to nonpowder guns (BB, pellet guns, paintball, etc.) increased by over 150% during the study period, while the overall rate of eye injuries related to sports and recreation decreased slightly.

First OTC Low-Dose Brimonidine Eye Drop Approved for Ocular Redness

By December 26, 2017

Brimonidine is already approved in higher doses as a prescription eye drop for the treatment of intraocular pressure reduction in glaucoma patients.

Over-the-Counter Tx May Slow Age-Related Macular Degeneration

August 25, 2017

The investigators found that both formulations were cost-effective for treating patients with early-stage disease, but they were even more cost-effective for those with the condition in only 1 eye.

FDA Approves Zerviate for Allergic Conjunctivitis

By June 01, 2017

Zerviate is the first topical ocular formulation of cetirizine.

Teprotumumab for Thyroid-Associated Ophthalmopathy

By May 04, 2017

Smith, TJ et al. "Teprotumumab for Thyroid-Associated Ophthalmopathy". DOI: 10.1056/NEJMoa1614949.

Tocilizumab Assessed for JIA-Associated Uveitis

March 17, 2017

Rapid and maintained improvement in all ocular parameters was seen with tocilizumab treatment.

Dextenza NDA Resubmission Accepted for Post-Surgical Ocular Pain

By February 23, 2017

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

By January 23, 2017

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

December 15, 2016

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

By November 29, 2016

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

By November 28, 2016

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

By November 04, 2016

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).