AAO Asks CMS for Meaningful Use Relief
In response to the release of a final rule on Meaningful Use of electronic health records, the American Academy of Ophthalmology (AAO) asked the Centers for Medicare and Medicaid Services (CMS) for a hardship exemption from implementing the requirements of the program, according to a statement from the AAO.
The final rule requires a reporting period of 90 days, but it was released less than 90 days from the end of 2015 (October 6). If ophthalmologists were waiting for the final rule modifications in order to begin reporting, they do not have enough time to do so. The AAO has joined a coalition that includes the American Medical Association and other stakeholders, asking that CMS create “a new hardship-exception category for eligible professionals impacted by the delayed rulemaking,” according to a statement provided to Retina Today.
The coalition has previously asked CMS to delay implementing the stage 3 rules that were finalized in the October 6 ruling. The coalition argued that delaying stage 3 is the only means by which CMS can understand the effects of stage 1 and stage 2 rules. The coalition also organized a letter to the Office of Management and Budget, signed by 116 members of the US House of Representatives, asking for a delay of stage 3 rulemaking.
Valeant Completes Acquisition of Synergetics USA
Valeant Pharmaceuticals International announced that it has completed its acquisition of Synergetics USA at a price per share of $6.50. In addition to the upfront cash payment, Synergetics stockholders will receive additional cash payments of up to $1 per share if specified sales milestones are achieved following the closing.
As a result of the merger, Synergetics will become a wholly owned subsidiary of Valeant. Following completion of the merger, the common stock of Synergetics will no longer be listed for trading on the NASDAQ Capital Market.
Phase 3 Trial for Gene Therapy Meets Primary Endpoint
A phase 3 clinical trial assessing the safety and efficacy of SPK-RPE65 (Spark Therapeutics) for the treatment of RPE65-mediated inherited retinal dystrophies met its primary endpoint, according to a press release. Based on the results of the study, Spark Therapeutics intends to file a biologics license application with the US Food and Drug Administration (FDA).
The clinical trial’s primary endpoint was improvement in functional vision, as measured by change in bilateral mobility testing, between baseline and 1 year.
Patients in the treatment group also outperformed control group patients in two secondary endpoints of the trial: full-field light sensitivity threshold testing and mobility test change score for the first injected eye. No improvement in visual acuity was observed.
There were no serious adverse events related to SPK-RPE65, and no deleterious immune responses were observed in the trial.
Pediatric Retinoblastoma Burden Linked With Socioeconomic Factors
Hispanic children with retinoblastoma had more advanced disease and a higher rate of enucleation than non-Hispanic children in a population-based review of cancer registries, according to research published in JAMA Pediatrics.1
Researchers reviewed county-level socioeconomic data for 830 patients diagnosed with retinoblastoma. Hispanic children had a higher percentage of extraocular disease (33%) than non-Hispanic children (20%). The percentage of extraocular cases was also higher in counties with low economic status indicators: low educational attainment, high poverty status, high crowding, high unemployment, high language isolation, or a high percentage of immigrants.
Enucleation rates were also linked with low socioeconomic factors, including low educational attainment, high crowding, and Hispanic origin. Relative survival at 5 years was lower among black children than among non-Hispanic white children.
The data led the study authors to speculate on the relationship between socioeconomic status and retinoblastoma care and outcome, saying that “low socioeconomic status negatively affects disease extent and ocular outcomes, presumably by limiting access to primary and cancer-directed care.”
1. Truong B, Green AL, Friedrich P, et al. Ethnic, racial, and socioeconomic disparities in retinoblastoma [published online ahead of print October 5, 2015]. JAMA Pediatrics.
Study: Oral Fluoroquinolone Not Linked With Uveitis
Researchers found no link between uveitis and oral fluoroquinolone use, according to a study published in JAMA Ophthalmology.1
In a retrospective cohort study examining claims data from a large national US insurer, researchers reviewed nearly 4.4 million claims of patients who were first-time users of an oral fluoroquinolone or a ß-lactam antibiotic. Patients with a history of uveitis or uveitis-associated systemic illness were excluded from the study.
After controlling for age, race, and sex, researchers found no higher likelihood of developing uveitis at 30, 60, or 90 days for patients taking an oral fluoroquinolone than for those taking ß-lactam antibiotics. Moxifloxacin use showed an increased hazard for uveitis at each time point.
Secondary analysis showed a hazard for development of a uveitis-associated systemic illness after fluoroquinolone use. The study authors noted that this was “a possible source of bias that could explain the findings of previous studies” suggesting a link between oral fluoroquinolone use and uveitis risk.
1. Sandhu HS, Brucker AJ, Ma L, VanderBeek BL. Oral fluoroquinolones and the risk of uveitis [published online ahead of print October 29, 2015]. JAMA Ophthalmol.
Phase 2 Study on Port Delivery System Begins
A phase 2 clinical trial investigating anti-VEGF delivery via a port delivery system implant in patients with wet AMD has begun, according to a press release.
Patients in the phase 2, interventional, randomized, double-masked, active comparator, multicenter study will receive one of three formulations of ranibizumab (Lucentis, Genentech) delivered via the implant or standard-of-care monthly intravitreal injections of 0.5 mg ranibizumab. The primary endpoint of the study is time until the implant must be refilled; secondary endpoints include BCVA and anatomic response as measured on optical coherence tomography.
The ranibizumab port delivery system is inserted in the eye using standard surgical techniques and requires no sutures. It is refillable using a special needle in a minimally invasive office-based procedure.
In a phase 1 study, the implant was well tolerated and showed an improvement in BCVA comparable with monthly injections.
Trial of Stem Cell Therapy for Wet AMD Begins
Retinal pigment epithelium (RPE) cells derived from stem cells have been transplanted into a patient with wet AMD. The patient is the first of 10 to be enrolled in a clinical trial to assess the safety and efficacy of RPE cell transplant in patients with wet AMD. The transplant occurred at Moorfields Eye Hospital in London.
The patient will be followed until the end of 2015, according to a report in BBC News. No complications had been reported as of press time.
Interim Data Show Positive Response to Iontophoretic Therapy for Macular Edema
Iontophoresis can noninvasively deliver EGP-437 (EyeGate) to the back of the eye, according to investigators reviewing interim data from a phase 1b/2a study of iontophoretic EGP-437 ophthalmic solution in patients with macular edema.
In the ongoing multicenter, open-label clinical trial, 19 patients with macular edema secondary to retinal vein occlusion (RVO), diabetic retinopathy, or cystoid macular edema received three treatments of EGP-437 ophthalmic solution delivered iontophoretically at
14.0 mA-min on days 0, 4, and 9. The primary outcome of the trial was reduction in mean central subfield thickness on days 4, 9, and 14.
In a press release, the company reported that a positive response was observed in some patients and that pseudophakic patients responded better than phakic patients. Also, no serious treatment-related emergent adverse effects, including increased intraocular pressure, were observed.
An extension trial expected to begin by the end of 2015 will enroll an additional 15 patients.
Psoriasis, Hypertension Associated With RVO Risk
Patients with psoriasis or comorbid psoriasis and hypertension were more likely than those without psoriasis to develop RVO, according to a study published in Retina.1
In a retrospective population-based cohort study, researchers reviewed nearly 62 000 patients, half of whom had psoriasis, from the Taiwan National Health Insurance Research Database. Those with psoriasis were nearly 1.5 times more likely to develop RVO compared with those without the skin disease. Among patients 65 years or older, those with psoriasis were nearly twice as likely to develop RVO as those without psoriasis. Patients with hypertension and psoriasis were more than twice as likely to develop RVO as those without psoriasis.
1. Yen YC, Weng SF, Lai FJ, Lin YS. Risk of retinal vein occlusion in patients with psoriasis: a population-based cohort study. Retina. 2015;35(9):1786-1794.
IND Application Filed for Gene Therapy for Achromatopsia
AGTC filed an investigational new drug (IND) application with the FDA requesting permission to conduct a phase 1/2 trial of the company’s gene therapy product candidate for the treatment of achromatopsia caused by mutations in the CNGB3 gene, according to a company press release.
This is AGTC’s second IND application in 2015. In March, the company filed an IND application for a phase 1/2 trial to evaluate the company’s gene therapy product candidate for the treatment of X-linked retinoschisis.
Phase 2 Trial for Macular Edema Secondary to Uveitis Completes Enrollment
The phase 2 Dogwood trial evaluating the safety and efficacy of CLS-TA (Clearside Biomedical) delivered via the suprachoroidal space for the treatment of macular edema associated with noninfectious uveitis has completed enrollment, according to a press release. CLS-TA is Clearside’s proprietary form of triamcinolone acetonide.
Dogwood is a masked, randomized trial with a primary efficacy endpoint of mean change from baseline in retinal thickness at 2 months. A secondary efficacy endpoint is visual acuity improvement at 1 and 2 months. n