In an effort to validate the accuracy, consistency and reliability of diagnostic testing, the FDA has announced its intent to issue a final guidance document on the development, review and approval of companion diagnostics. The agency has also alerted Congress that it will publish a risk-based oversight framework for laboratory-developed tests, according to an agency press release. “Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA commissioner Margaret A. Hamburg, MD, said in (Read more...)
Author: Healio ophthalmology
Valeant second-quarter total revenue increases 86%
Valeant Pharmaceuticals reported a total revenue of $2 billion for the second quarter of 2014, up 86% from the second quarter of 2013. The company’s net income was $126 million, or $0.37 per diluted share. Based on cash earnings per share, Valeant’s adjusted income increased by 43% from the previous year at $651 million, or $1.91 per diluted share, according to a company press release.
Woman reports ‘sparks’ during routine eye exam
In this Ocular Surgery News publication exclusive, Kristen Dunbar, MD, and Caroline Baumal, MD, of the New England Eye Center at Tufts University School of Medicine, discuss a case in which a fundus exam of the left eye showed an inferotemporal excavation in the optic nerve head with a serous retinal detachment.A 19-year-old female college student was referred by an outside optometrist for retinal evaluation of her left eye. She initially presented for a routine annual exam with no visual complaints. On further questioning, she noted occasional “sparks” in her (Read more...)
Merck announces Q2 financial results
Merck’s second-quarter worldwide sales were $10.9 billion, marking a 1% decrease from the same time last year, according to a company press release. Pharmaceutical sales declined by 2% to $9.1 billion, while second-quarter global sales of consumer care products were $583 million, marking a 19% increase from the previous period in 2013.
Poll shows 25 million older adults received unwanted medical care
About 25 million older Americans have been subjected to unwanted or excessive medical treatments, according to new survey data. The research was sponsored by Compassion & Choices, a nonprofit, end-of-life patient advocacy group. A poll of 1,007 individuals aged 50 years and older was conducted by Purple Insights, a research division of Purple Strategies.
Intensive ranibizumab treatment of AMD linked to vascular adverse events
Intensity of intravitreal ranibizumab treatment for age-related macular degeneration may be linked to vascular adverse events, but not to an increased risk of mortality, according to researchers.The researchers conducted a meta-analysis of 11 randomize…
Range of options available for IOL calculations
CEDARS Debates is a monthly feature in Ocular Surgery News. CEDARS — Cornea, External Disease, and Refractive Surgery Society — is a group of cornea, cataract and refractive surgery specialists, here to discuss some of the latest hot topics in ophthalmology.With laser refractive surgery becoming so widespread over the past 20 years, there is now an ever-increasing number of post-refractive patients who require cataract surgery.
FDA approves Eylea for treatment of diabetic macular edema
The U.S. Food and Drug administration has approved Eylea for treatment of diabetic macular edema, according to a Regeneron Pharmaceuticals press release.This is the third FDA-approved indication for the aflibercept injection, which was approved for tre…
New contrast sensitivity test reliable for detection of early glaucoma
A new contrast sensitivity test demonstrated reliability in identifying patients with glaucoma, according to a study.The Spaeth/Richman Contrast Sensitivity Test (SPARCS) is designed to gauge the contrast threshold of patients’ central vision and peripheral vision. The internet-based test features multiple-choice questions and a bracketing technique to determine contrast threshold.
McDonald confirmed as new VA secretary
Robert McDonald, a West Point graduate and former CEO of Proctor and Gamble, has been confirmed as the next secretary of the Department of Veterans’ Affairs.President Barack Obama praised the Senate’s unanimous decision.
Glaucoma Treatment Study: Visual field loss, improvement comparable through 5 years
Comparable rates of visual field loss and improvement were seen until 5-year follow-up of the Collaborative Initial Glaucoma Treatment Study, at which time visual field loss became more common, according to a study. The prospective, comparative case se…
Back to Basics: Unusual cases alter accuracy of IOL power calculations
For average eyes, IOL power estimation calculations are reasonably accurate because the assumptions that are made by the formulae all hold true: The anterior chamber is an average depth, the corneal curvature and axial length are accurately measured by our machines, and the future position of the IOL is accurately predicted. However, there are some clinical situations in which the IOL calculation is not as accurate, and we can end up with a refractive surprise.The surgeon should be aware of a patient’s history, review the biometric information in detail and (Read more...)
PK, DSAEK offer similar graft survival rates regardless of glaucoma therapy
Penetrating keratoplasty and Descemet’s stripping automated endothelial keratoplasty had comparable graft survival rates in eyes without glaucoma management and in eyes with comparable glaucoma management, according to a study.Researchers performed a retrospective chart review for 57 eyes that underwent PK and 156 eyes that underwent DSAEK. Patients’ eyes were categorized as having no glaucoma treatment, medical therapy only or surgical intervention.
Simbrinza approved in EU for treatment of glaucoma
The European Commission has approved brinzolamide and brimonidine tartrate eye drops suspension for the treatment of elevated IOP in adults with open-angle glaucoma or ocular hypertension, according to a press release.Brinzolamide 10 mg/mL and brimonid…
Ophthalmic Premier League Symposium offers friendly competition among surgeons
The Ophthalmic Premier League Symposium, a team video competition, will be debuted at the 2014 American Academy of Ophthalmology. “The video format makes this symposium very interesting for ophthalmologists, and added to it is the competition element where the ophthalmologists in the audience can vote and decide the best team,” Agar Agarwal, MD, told Ocular Surgery News in an interview.
Ten-point scorecard can assess administrator prowess
In today’s complex and changing practice world, few factors are as critical to practice success as your administrator’s global fitness. OSN Practice Management Board Member and Healio.com/Ophthalmology blogger Corinne Z. Wohl, MHSA, COE, an experienced hospital and practice administrator, provide insight into how the success of your administrator has a direct effect on the success of your practice.What follows is a simple “administrator’s scorecard.” It will help you answer one of the most common questions asked of practice management consultants: “How is my manager doing?”
Boston type 1 keratoprosthesis produced favorable long-term outcomes
Despite an increase in complications with longer follow-up, Boston type 1 keratoprosthesis was shown to have lasting positive effects during a 7-year period, according to study findings. The retrospective study included 139 eyes of 133 patients who und…
DALK after treatment of keratoconus-associated hydrops improves visual acuity
Deep anterior lamellar keratoplasty performed after combined thermokeratoplasty and anterior chamber paracentesis improved vision and resolved membrane ruptures in patients with hydrops associated with keratoconus, according to study findings.The retro…
Top 4 glaucoma surgery videos
The emergence of technologies for the treatment of glaucoma continue to set the stage for further approaches that target patients with the condition.Minimally-invasive transscleral glaucoma surgery techniques and stab incision glaucoma surgery have tak…
Nonsurgical option available for long-standing or sensory strabismus in adults
In this News You Can Use from UPMC Eye Center publication exclusive, Lea Ann Lope, DO, at Children’s Hospital of Pittsburgh, provides insight into the use of Botox to treat strabismus in adults.With Botox, improvements in the position of the eye can be seen even after the initial 3-month paresis has worn off.