Ophthalmic Disorders

FDA Accepts Durasert NDA for 3-Year Treatment of Posterior Segment Uveitis

By March 22, 2018

The FDA have set a Prescription Drug User Fee Act (PDUFA) date of November 5, 2018 for Durasert.

Additional Strength of Lucentis Prefilled Syringe FDA-Approved

By March 21, 2018

The 0.3mg PFS marks the first approved syringe with an anti-vascular endothelial growth factor (VEGF) to treat all forms of diabetic retinopathy with or without diabetic macular edema (DME).

Eylea Meets Endpoint in Non-Proliferative Diabetic Retinopathy Trial

By March 19, 2018

Results so far (at week 24) show more than half of patients who received Eylea experienced a 2-step or greater improvement from baseline on the DRSS vs. patients who received a sham injection (58% vs 6%; P<0.0001).

Dexycu Approved for Treating Inflammation Following Cataract Surgery

By February 12, 2018

Dexycu (dexamethasone intraocular suspension) injection has been approved for the treatment of inflammation associated with cataract surgery.

Prevalence of Persistent DME Evaluated After Anti-VEGF Therapy

February 02, 2018

Persistent diabetic macular edema more likely with bevacizumab than aflibercept or ranibizumab

Diet Soda Independently Linked to Higher Diabetic Retinopathy Risk

January 30, 2018

Compared to those with no diet soft drink consumption, there was an independent association between high diet soft drink consumption and increased likelihood of having PDR (odds ratio, 2.51).

Growth hormone releasing hormone (GHRH) agonists protect against diabetic retinopathy in animal model

January 19, 2018

GHRH and GHRH receptor levels are decreased in diabetic rats and humans.

Noninvasive Marker May ID Severity of Diabetic Retinopathy

January 18, 2018

"Further longitudinal studies seem warranted to determine whether DRIL is a clinically relevant noninvasive morphological marker in eyes with DME," the authors write.

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.

Static Perimetry Test May Benefit Children With Glaucoma

January 05, 2018

"A simple static perimetry approach potentially yields high-quality results in children younger than 10 years," the authors write.

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.

Luxturna Approved to Treat Inherited Form of Vision Loss

By December 19, 2017

Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.

Novel Once-Daily Eye Drop Approved for Lowering Elevated IOP in Glaucoma

By December 19, 2017

Rhopressa (netarsudil ophthalmic solution) 0.02% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Treatment for Leber's Hereditary Optic Neuropathy Gains Fast Track Status

By December 18, 2017

Elamipretide has also been granted Fast Track designation for treating primary mitochondrial myopathy (PMM) - which gained Orphan Drug Designation in September - and Barth syndrome

Beverage Consumption Linked to Lower Glaucoma Odds

December 15, 2017

There were no significant associations between glaucoma and consumption of caffeinated and decaffeinated coffee, iced tea, and soft drinks.

Intraocular Hemorrhage Occurrence for Novel vs. Traditional Antithrombotic Agents

December 14, 2017

The researchers found that the risk of developing an intraocular hemorrhage was reduced with dabigatran or rivaroxaban at 365 days (hazard ratio, 0.75; 95% confidence interval, 0.58 to 0.97; P=0.03) but not at 90 days (hazard ratio, 0.73; 95% confidence interval, 0.22 to 2.63; P=0.13).

Omidria Approved for Use in Pediatric Patients

By December 12, 2017

FDA gave approval following review of efficacy and safety data from a pediatric clinical trial.

Case: Acute Solar Retinopathy After Viewing Eclipse

December 11, 2017

"We have never seen the cellular damage from an eclipse because this event rarely happens and we haven't had this type of advanced technology to examine solar retinopathy until recently," study author Avnish Deobhakta.

FDA Approves Intraocular Lens That Can Be Adjusted Post-Cataract Surgery

By November 27, 2017

First medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not using glasses.

Clinical Characteristics of Endogenous Endophthalmitis Examined in Injection Drug Users

November 20, 2017

Injection drug users have fewer comorbidities and more improvement in visual acuity after intervention

Soluble Interleukin 2 Receptor Assessed as Biomarker of Sarcoidosis in Uveitis

November 13, 2017

To compare the value of soluble interleukin 2 receptor (sIL-2R) with ACE as diagnostic biomarkers of sarcoidosis in patients with uveitis.

Ranibizumab Plus Dexamethasone vs. Ranibizumab Alone in DME

November 13, 2017

The researchers found that the mean improvement in visual acuity from randomization was 2.7 and 3 letters in the combination and ranibizumab groups, with the adjusted treatment group difference of −0.5 letters.

Experts Pick the Top 10 Medical Innovations for 2018

By November 03, 2017

The panel - made up of nearly 100 physicians and scientists - debated and whittled down over 150 nominations to decide upon the final 10.

Vyzulta Approved to Treat Patients With Open-Angle Glaucoma, Ocular HTN

By November 03, 2017

Vyzulta works by metabolizing into two moieties, latanoprost acid, which primarily works within the uveoscleral pathway to increase aqueous humor outflow, and butanediol mononitrate, which releases NO to increase outflow through the trabecular meshwork and Schlemm's canal.

Bacterial Conjunctivitis Treatments

October 30, 2017

Bacterial conjunctivitis treatment chart for topical medications.

Recall of Two Glaucoma Medications Announced

By October 27, 2017

The recall applies to Combigan 0.2%/0.5% lots in 2.5mL, 5mL, 10mL and 15mL sizes, and one lot of Lumigan 0.01%.

First Gene Tx for Inherited Retinal Disease Gets Thumbs Up from FDA Committee

By October 13, 2017

The recommendation was based on data from the Luxturna clinical development program which included a Phase 3 trial in patients 4-44 years of age.

Glaucoma Treatments

October 13, 2017

Glaucoma treatment chart (alpha2-agonists, beta blockers, carbonic anhydrase inhibitors, cholinergic agonists, prostaglandin analogs).