Miscellaneous Ocular Agents
"Further longitudinal studies seem warranted to determine whether DRIL is a clinically relevant noninvasive morphological marker in eyes with DME," the authors write.
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).
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 is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.
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.
Elamipretide has also been granted Fast Track designation for treating primary mitochondrial myopathy (PMM) - which gained Orphan Drug Designation in September - and Barth syndrome
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).
"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.
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.
To compare the value of soluble interleukin 2 receptor (sIL-2R) with ACE as diagnostic biomarkers of sarcoidosis in patients with uveitis.
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 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.
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.
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.
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.
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%).
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
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.
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 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.
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.
One in 5 of the infants had sight-threatening eye abnormalities, with optic nerve and retinal abnormalities the most common.
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.
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.
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).
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.
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).