Miscellaneous Ocular Agents
The approval was based on data from a randomized, double-masked, placebo-controlled study of 90 pediatric patients aged 2 to < 18 years with active JIA-associated non-infectious uveitis.
Participants with a high MeDi score showed a significantly reduced risk for incident advanced AMD versus participants with a low score (range, 6 to 9 vs 0 to 3) in the fully adjusted model using data for both the RS-I and Alienor Study (hazard ratio, 0.59).
Data from two Phase 3, multicenter, randomized, double-masked, placebo-controlled trials showed a greater proportion of patients treated with Inveltys having complete resolution of ocular inflammation.
The safety and efficacy of Oxervate was evaluated in 2 independent, double-masked, randomized, multicenter, controlled clinical trials involving patients with moderate to severe neurotrophic keratitis.
The approval was supported by year 2 data from the Phase 3 VIEW 1 and VIEW 2 trials that evaluated 2412 patients with wet AMD who followed a modified 12-week dosing schedule (doses at least every 12 weeks and additional doses as needed).
The woman couldn't recall how the contact lens got there or how long it was there, but her mother remembered that she had been hit in the eye with a shuttlecock during a game of badminton 28 years ago.
There were differences in steepest keratometry of 47.35 diopters in patients with DS vs 43.7 diopters in control subjects. There were also differences in corneal pachymetry of 503µm in patients with DS versus 545µm in controls.
Compared with children in the control group, children with amblyopia had a slower mean time to completion (P=.001), as did children with non-amblyopic strabismus (P=.002).
GPLSCD01 is an investigational treatment made up of ex vivo expanded autologous human corneal epithelial cells containing stem cells.
A U.K. university graduate with 17 years of education would be at least −1 dioptre more myopic, on average, than someone who left school at age 16 with 12 years of education.
In a clinical trial of 389 individuals with iris defects, 70% of patients reported a significant decrease in light sensitivity and glare.
The patients were 2 white men aged 52 and 85 years with metastatic cutaneous melanoma and a 68-year-old African-American man with metastatic adenocarcinoma of the lung. All 3 patients were receiving anti-PD-1 and anti-PD-L1 monoclonal antibody therapy.
All lesions respected the horizontal raphe, and the fovea was spared. A V-shaped hyperreflectivity of the outer nuclear layer was seen with OCT imaging, overlying discontinuities of the ellipsoid zone and interdigitation zone in smaller lesions.
The approval was based on results from 3 randomized trials which found that Rhopressa was associated with a reduction in intraocular pressure of up to 5mmHg.
XLRP represents the most severe form of retinitis pigmentosa (RP), an inherited retinal disease characterized by progressive retinal degeneration and vision loss that ends in complete blindness.
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.
This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.
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.
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.
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.
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%.
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.
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).
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).
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).