On March 8, the FDA published in the Federal Register a notice of the availability of its draft five-year plan describing the Agency’s approach to developing and implementing a structured framework for benefit-risk assessment.Publication of this plan fulfills one of FDA’s obligations under the Food and Drug Administration Safety and Innovation Act (FDASIA). The plan sets out FDA’s initial benefit-risk framework, which incorporates key decision factors of Analysis of Condition, Current Treatment Options, Benefit, Risk and Risk Management.
Author: Healio ophthalmology
Treat and extend regimen for CRVO shows modest success
PHILADELPHIA — A treat-and-extend regimen of anti-VEGF therapy for macular edema from central retinal vein occlusion offered advantages but was less successful than a similar protocol for age-related macular degeneration, according to a study presented here.Advantages of a treat-and-extend regimen for CRVO included fewer office visits and injections, a lower risk of side effects and lower cost, Christopher J. Brady, MD, said at the Wills Eye Institute Annual Conference.
World Glaucoma Week focuses on education, support
World Glaucoma Week runs through March 16, and organizers are hoping the time is spent educating the more than 60 million current glaucoma patients worldwide, along with those at risk of the disease, about symptoms and treatment options.The event, run …
Glaucoma surgery improves quality of life but does not reduce rate of blindness
PHILADELPHIA — Despite steady improvements in recent decades, glaucoma surgery has a minimal impact on blindness from glaucoma in the United States, a guest speaker said here.“We really haven’t changed anything in 30 years, I’m sorry to say,” Peter A. Netland, MD, PhD, said during the Arthur J. Bedell Lecture at the Wills Eye Institute Annual Conference. “Glaucoma surgery really has a minimal impact on blindness due to glaucoma. Even if we had the perfect surgery, if it was 100% effective, zero complications, zero difficulty and 100% convenient … we’d still have similar rates of glaucoma and rates of blindness due to glaucoma today if we looked at our population in the United States.”
BLOG: It’s a great time to be a presbyope
Just a few years ago, I used to regularly make fun of my more senior friends and colleagues when they donned their reading glasses to see fine print. Now, at age 46, presbyopia doesn’t seem so funny anymore. Thankfully, a number of great technologies promise hope for us oldies. Personally, I love offering patients both the multifocal and accommodating IOLs that are approved but am very excited about newer, better IOL technologies. That is, if the FDA will ever approve them.More exciting still are the burgeoning technologies for the younger, emmetropic presbyope. Three corneal inlays are nearing approval in the U.S., and each offers promising results so far. The exciting thing about these inlays is they improve near vision in one eye while degrading distance vision much less than traditional monovision.
Study shows association between pseudoexfoliation and nuclear cataract
Pseudoexfoliation syndrome was found to be associated with an elevated risk of nuclear cataract in older subjects, according to a large study.Data were culled from the Blue Mountains Eye Study, a population-based cohort study conducted in Australia. In…
Seven new loci linked to AMD
Researchers have identified seven new loci linked to age-related macular degeneration, offering potential new avenues for biologic, therapeutic and genetic studies of the condition, according to a letter published by the AMD Gene Consortium.The researc…
ACA could increase demand for primary care, exceed supply by 10%
The Affordable Care Act’s expansion of insurance coverage could increase demand for primary care, thus exceeding services by 10%, according to data published in Health Affairs. Researchers who conducted the study have called for future policy research to meet the demand.“That increase, in turn, will boost demand for primary care services, potentially straining the primary care workforce and even limiting access to health care for both the newly and the currently insured,” the researchers wrote.
AAO: Federal budget cuts may restrict Medicare patients’ access to eye care
Automatic cuts in the 2013 federal budget will adversely affect Medicare patients and jeopardize access to care, the American Academy of Ophthalmology announced.The cuts, part of the sequestration, took effect March 1 and total $85 billion. They includ…
Genetic test for Avellino corneal dystrophy launched
The Avellino-Gene Detection System has been launched in the U.S. to help patients and physicians make a more informed decision before going forward with vision correction surgery, including LASIK, LASEK and PRK, according to a news release from Avellino Lab USA.The test can determine whether patients carry the Avellino corneal dystrophy gene mutation that puts them at higher risk for the disease, which causes corneal opacity and potential blindness, the release said. Laser surgery can exacerbate the problem, according to the company’s website.
Iridex net income down in 2012
Iridex reported a net income of $1.44 million in 2012, down from $2.61 million in 2011, according to a news release.Gross profit for the year was $16.35 million, up from $16.29 million the previous year, while total operating expenses increased to $17….
PRK may treat myopia, astigmatism in suspected keratoconic eyes over long term
PRK was an effective treatment for mild myopia and astigmatism in select patients diagnosed with suspected keratoconus, according to a study.The retrospective case analysis included 62 eyes of 42 patients who underwent myopic PRK using an EC-5000 excim…
BLOG: President’s sequestration order cuts Medicare payments to physicians and hospitals by 2%
President Obama signed the long-awaited sequestration order on March 1, officially cutting more than $85 billion from the federal budget for 2013. Coverage of these cuts, in both the popular media and trade press, has focused on the impact on programs for some of the country’s most vulnerable citizens. Perhaps most notably for older patients and those who care for them, however, roughly 12% of the total budget cuts (approximately $11 billion) will come from reductions to the Medicare budget.
Surgeon explains reimbursement changes amid new billing environment
SAN FRANCISCO — Surgeons face a mixed bag of reimbursement increases and decreases, based on revised guidelines and valuation changes, a surgeon said here.“I think [there’s] probably a lot of good news for those using the femtosecond [laser] with premium IOLs. There’s bad news for cataract, but some good news with respect to the reimbursement for [microincision glaucoma surgery],” David F. Chang, MD, said at the American Glaucoma Society annual meeting.
Using shunts to control aqueous flow to suprachoroidal space may be key to lowering IOP
SAN FRANCISCO — In glaucoma patients, the suprachoroidal space may be the ideal location for an IOP-lowering procedure, according to a presenter here.“Communicating the anterior chamber with the suprachoroidal space dramatically reduces IOP; however, if a procedure can control the amount of flow to the suprachoroidal space, it could be an ideal approach to lowering IOP,” Celso Tello, MD, said at the American Glaucoma Society annual meeting.
IOP reduced after implantation of two micro-bypass stents
SAN FRANCISCO — Two trabecular micro-bypass stents and a prostaglandin analogue may reduce IOP and medication use in patients with open-angle glaucoma, according to a prospective study presented here. Two iStents (Glaukos) were implanted in 41 open-angle glaucoma patients with travoprost prescribed postoperatively, Thomas W. Samuelson, MD, OSN Glaucoma Section Editor, said in a poster presented at the American Glaucoma Society annual meeting.
BLOG: Fee-for-Service Reimbursement – The End is Near?
From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.On March 4, the National Commission on Physician Payment Reform (NCPPR) released its final recommendations for reining in healthcare spending. Sponsored by the Society of General Internal Medicine (SGIM) and the Robert Wood Johnson Foundation (RWJF), the NCPPR is an independent commission created “to assess how physicians are paid, and how pay incentives are linked to patient care.” After a year of study and deliberation, the NCPPR identified twelve recommendations to address systemic and Medicare-specific issues in today’s prevailing physician reimbursement models.
Ophthalmic clinical registry would enhance compliance, outcomes and revenues
SAN FRANCISCO — An ophthalmic clinical registry would help ophthalmologists improve outcomes, comply with government regulations and boost revenues, according to a speaker.At the American Glaucoma Society annual meeting, William L. Rich III, MD, the medical director of health policy for the American Academy of Ophthalmology, outlined the form, function and potential benefits of registries.
Combination of micro-stent implant, cataract surgery lowers IOP in open-angle glaucoma
SAN FRANCISCO — In mild to moderate open-angle glaucoma, suprachoroidal micro-stent implantation in conjunction with phacoemulsification may safely lower IOP, according to a presenter here.The objective of the device is to sustain a low IOP, as well as reduce the dependence on antihypertensive medications, Steven D. Vold, MD, said at the American Glaucoma Society annual meeting.
Physicians need to be prepared for IOP spikes after glaucoma surgery
SAN FRANCISCO — Glaucoma procedures, even minimally invasive ones such as trabecular meshwork ablation, require preparation for potential complications including IOP spikes, a presenter said here.”The best offense is a good defense, and avoiding such complications is truly better than managing them,” Carla J. Siegfried, MD, said at the American Glaucoma Society annual meeting.