Miscellaneous Ocular Agents

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

Zika Associated with Similar Retinal Problems as Cobalamin C Deficiency

September 08, 2017

In 7 of 8 eyes with a normal photoreceptor layer, pericentral retina with normal lamination showed a thinned (<30% of normal thickness) ganglion cell layer (GCL) that colocalized.

USPSTF Issues Vision Screening Recommendation for Children

September 06, 2017

The USPSTF concluded that the overall net benefit is moderate for children aged 3 to 5 years (B recommendation).

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.

The Dos and Don'ts of Viewing a Solar Eclipse

By August 18, 2017

The moon passes the sun so quickly (at 2880km/h) that most of the time individuals (even those in the direct path of totality) will be experiencing a partial eclipse, and will be exposed to the sun's core.

FDA: Vision Impairment, Other Serious Side Effects Tied to Compounded Injectable

By July 31, 2017

The triamcinolone and moxifloxacin injection was intended for use as post-op prophylaxis for ocular inflammation and endophthalmitis to eliminate the use of post-op eye drops.

Eye Exams Should Be Requirement for Infants Potentially Exposed to Zika

July 18, 2017

One in 5 of the infants had sight-threatening eye abnormalities, with optic nerve and retinal abnormalities the most common.

Early Biomarker May Help Differentiate Parkinsonism Disorders

July 12, 2017

Magnetic resonance imaging (T1-weighted and diffusion-weighted imaging) with a 3-T magnetic resonance imager revealed that the Parkinson's patients had significant alterations in optic radiation connectivity distribution.

NDA Accepted for Anti-Inflammatory Inj Post-Cataract Surgery

By June 26, 2017

Dexycu injection was developed to help compliance—especially among elderly patients—and avoid dosing errors associated with conventional treatments that depend on self-administered eye drops multiple times a day.

Can Dietary Vitamin K Protect Against Cataracts?

May 22, 2017

After adjustment for potential confounders, the risk of cataracts was lower among participants in the highest versus the lowest tertile of dietary vitamin K1 intake (hazard ratio, 0.71).

Implant Compared to Systemic Anti-inflammatory Therapy for Treating Uveitis

May 08, 2017

In seven-year follow-up, visual acuity better than with intravitreous fluocinolone acetonide implants

Novel Therapy Shows Potential in Thyroid-Associated Ophthalmopathy

May 04, 2017

The researchers found that in the intention-to-treat population, 69 and 20% of those who received teprotumumab and placebo, respectively, had a response at week 24.

Anti-VEGF Treatments Examined for Effects on Diabetic Retinopathy

April 28, 2017

Researchers conducted a secondary analysis of data from a comparative effectiveness trial for center-involved DME in 650 participants during 2 years of treatment with aflibercept (2mg), bevacizumab (1.25mg), or ranibizumab (0.3mg).