Miscellaneous Ocular Agents

One-Hour Plasma Glucose Useful Predictor of Diabetic Retinopathy

April 16, 2018

The researchers found that the prevalence and incidence of DR changed in a similar manner across the distributions of 1h-PG and 2h-PG concentrations.

FDA Approves Unique Device for Diabetic Retinopathy Screening

By April 11, 2018

This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.

Contact Lenses With Light-Adaptive Technology Get FDA Approval

By April 11, 2018

The contact lenses contain a photochromic additive that adapts the amount of visible light filtered to the eye based on the amount of UV light to which they are exposed.

Composite Subretinal Implants May Lessen Vision Loss From AMD

April 05, 2018

A composite implant which consists of a polarized monolayer of human embryonic stem cell-derived RPE on an ultrathin parylene substrate, may improve visual function in some patients.

Vitamin A Appears Helpful in Pediatric Retinitis Pigmentosa

April 02, 2018

The researchers found that in the unadjusted model, the estimated mean rates of change were −0.0713 loge unit/year for the vitamin A cohort and −0.1419 loge unit per year for the control cohort.

Early Age-Related Macular Degeneration Linked to High HDL

March 30, 2018

The researchers found that the incidence rates of early and advanced AMD were 79.9 and 18.6 per 1,000 person-years, respectively, corresponding to five-years risks of 32.9 and 8.9%.

Intravitreal Anti-VEGF Use Not Tied to Systemic Adverse Events

March 26, 2018

In the most recent and exhaustive reviews, bevacizumab was not associated with an increase in the risk of systemic adverse events compared with ranibizumab. In patients with age-related macular degeneration, ranibizumab may be associated with increased risk of nonocular hemorrhage compared with control treatments.

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).

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.

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

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.

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.

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.

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.

Do Electronic Health Records Present Increased Burden on Ophthalmologists?

October 13, 2017

The researchers found that the mean total ophthalmologist examination time was 11.2 minutes per patient, of which 27% was spent on EHR use, 42% on conversation, and 31% on examination.

Combo Verteporfin Tx Assessed in Polypoidal Choroidal Vasculopathy

October 10, 2017

Mean improvement at 12 months was 8.3 letters with combination therapy compared with 5.1 letters with monotherapy, demonstrating that combination therapy met the predefined criterion for noninferiority as well as being superior to monotherapy.

Infection Risk Investigated for Processed Tissue in Corneal Transplants

October 02, 2017

The researchers found that donor rim culture results were three times more likely to be positive for fungi in endothelial keratoplasty-processed eyes (1.14%) compared with other uses (0.37%).

Dietary Supplement Examined for Effects on Macular Pigment Density

September 29, 2017

The researchers found that there was a statistically significant increase in plasma lutein and zeaxanthin in the lutein plus zeaxanthin group after 3 months and 6 months of treatment versus the placebo group