On Tuesday, President Donald J. Trump issued a new health insurance rule that would roll back essential patient protections established by the Affordable Care Act, including important health benefit coverage requirements, according to a press release i…
Author: Healio ophthalmology
Quantel launches LacryDiag dry eye diagnosis device
At the World Ophthalmology Congress in Barcelona, Spain, Quantel Medical launched the LacryDiag ocular surface analyzer for the diagnosis of dry eye.
Approved by the FDA and CE marked, the device analyzes the three tear film layers with four non-contact exams, according to a company press release.
“Dry eye is a real public health problem, but the symptoms are often misunderstood. As a multifactorial pathology that results from damage to the tear film, this pathology is often underdiagnosed and underestimated,” Jean-Marc Gendre, CEO of Quantel Medical, said in the release. (Read more...)
Iridex’s Cyclo G6 glaucoma laser approved in South Korea
South Korea’s Ministry of Food and Drug Safety has approved the Cyclo G6 glaucoma laser system, Iridex announced in a press release.
The Cyclo G6 is available in more than 50 countries to treat patients with a range of glaucoma disease, the release said. It uses Iridex’s MicroPulse technology.
“International expansion in the Asia-Pacific region remains a top priority for us, and we believe that Korea represents an attractive market for our G6 technology,” President and CEO of Iridex William M. Moore said in the release.
AMA opposes CVS-Aetna merger
Barbara L. McAneny
AMA has determined that the proposed merger of CVS Health and Aetna should be blocked due to its likely negative consequences for patients and health insurance markets, according to a press release.
“After very careful consideration over the past months, the AMA has come to the conclusion that this merger would likely substantially lessen competition in many health care markets, to the detriment of patients,” Barbara L. McAneny, MD, president of AMA, said during testimony to California Department of Insurance.
During the analysis of the merger, the (Read more...)
Choroidal melanoma treatment shows promising early results in phase 1b/2 trial
Light-activated AU-011 for the treatment of primary choroidal melanoma was well tolerated with no severe adverse events, while showing promising early efficacy results, in a phase 1b/2 trial, Aura Biosciences announced in a press release.The open-label…
First Argentinian patient receives EyeMax Mono lens for AMD
The first EyeMax Mono lens implant procedure for age-related macular degeneration was performed in Argentina, LEH Pharma announced in a press release.
Hugo Nano, MD, of Buenos Aires, implanted the lens in both eyes of the patient. The device is delivered during cataract surgery and helps to improve vision in patients with wet or dry AMD, the release said.
“It is wonderful to have brought the EyeMax Mono lens into Argentina for the first time. The operation was a success, and this patient will be the first of many to (Read more...)
VIDEO: Simplifying the management of the loose lens
KIAWAH ISLAND, S.C. — At the Kiawah Eye meeting here, Michael D. Patterson, DO, discusses managing complicated cases.
First patient enrolled in phase 3 epi-on cross-linking trial
Avedro has enrolled the first patient in a pivotal phase 3 trial of its epi-on corneal collagen cross-linking procedure for progressive keratoconus, the company announced in a press release.
The multicenter, randomized, controlled study will evaluate the safety and efficacy of the procedure in 275 patients at 20 U.S. sites.
“Since the 2016 FDA approval of Avedro’s epi-off cross-linking treatment, thousands of patients with progressive keratoconus, a potentially debilitating disease, have benefited from this procedure,” Rajesh K. Rajpal, MD, chief medical officer for Avedro,
ICD-11 updates resistance codes, adds gaming as addictive disorder
WHO previewed a new International Classification of Diseases, ICD-11, which includes updates to codes related to antimicrobial resistance, adds gaming as an addictive disorder and categorizes gender incongruence as a matter of sexual health, not a ment…
FDA approves iDESIGN Refractive Studio for LASIK
Johnson & Johnson Vision’s iDESIGN Refractive Studio LASIK platform has been approved by the FDA, according to a press release.
The iDESIGN, which uses topography-integrated, wavefront-guided technology, allows physicians to take precise measurements of both the inside and outside of the eye to personalize the LASIK procedure to each patient, the release said.
It has been approved for myopia, hyperopia and mixed astigmatism, and is the only LASIK platform for monovision LASIK in presbyopic myopia.
“The new iDESIGN Refractive Studio provides surgeons with the ability to deliver
enVista toric MX60T IOL gets premarket approval
The FDA has issued premarket approval to Bausch + Lomb for its enVista toric MX60T hydrophobic acrylic IOL for astigmatism correction, according to a press release.
Featuring a one-piece aberration-free aspheric optic with a fenestrated, step-vaulted modified C-loop haptic design, the lens demonstrated 5° or less of absolute rotation in 100% of subjects in a prospective study, the release said.
“Building on the proven features and benefits of the enVista family of IOLs, MX60T represents another innovation in the continued expansion of this lens platform,” Chuck Hess, vice
VIDEO: White cataract in sarcoidosis patient with chronic uveitis
In this video, Farhan A. Irshad, MD, demonstrates the technique of removing a white cataract caused by chronic uveitis in a patient with sarcoidosis.Disclosure: Irshad reports he is a KOL for Bausch + Lomb.
VIDEO: Secrets of highly successful cataract surgery practices
KIAWAH ISLAND, S.C. — John A. Hovanesian, MD, FACS, OSN Cataract Surgery Section Editor, gives tips on running a successful cataract practice at the Kiawah Eye meeting here.
VIDEO: Advanced technology and treatments for tough dry eye patients
KIAWAH ISLAND S.C. — OSN Cornea/External Disease Board Member Preeya K. Gupta, MD, discusses managing tough dry eye patients at the Kiawah Eye meeting here.
VIDEO: Streamlining the premium cataract surgery experience
KIAWAH ISLAND, S.C. — At the Kiawah Eye meeting here, Keith A. Walter, MD, discusses streamlining cataract surgery from the femtosecond laser to the postop experience.
New study suggests ‘Right to Try’ may undo efforts on patient safety
The balance between investigational new drug access and protection of patients from therapies without established safety the FDA built during the past 20 years could be compromised by the new Right to Try law, a new study in JAMA Network Open suggests.
“To our knowledge, no studies have examined the timing and duration of drugs made available through expanded access programs to determine whether the program was serving its original purpose,” Jeremy Puthumana, MS, of the division of medical ethics at Yale School of Medicine, and colleagues wrote.
Researchers used (Read more...)
GenSight reports additional phase 3 data of GS010 for Leber hereditary optic neuropathy
Additional data from GenSight’s REVERSE phase 3 clinical trial of GS010 for the treatment of Leber hereditary optic neuropathy show the single intravitreal injection met some secondary endpoints, according to a press release.
Topline results, which were reported in April, showed the treatment did not meet its primary endpoint of +15 ETDRS letters difference compared with sham-treated eyes but did meet secondary endpoints as defined by spectral-domain OCT parameters.
On further analysis, some secondary endpoints did not have significant or meaningful changes. Contrast sensitivity, however,
VIDEO: The battle of the calculators: Transitioning to modern-day IOL formulas
KIAWAH ISLAND, S.C. — Karolinne M. Rocha, MD, PhD, discusses calculating IOL formulas at the Kiawah Eye meeting here.
Optovue receives three 510(k) clearances
Optovue has received 510(k) clearances from the FDA for its AngioAnalytics OCT angiography blood vessel measurement technology and for its 3-D projection artifact removal software, as well as expanded clearance for noncontact, quantitative measurements…
AMA passes new policies on naloxone, Medicaid, augmented intelligence
A broad spectrum of policies, actions and resolutions, ranging from naloxone access, Medicaid waivers and other topics, were voted on by the AMA delegates at their annual meeting, according to a press release. The meeting recently wrapped up in Chicago.
Increasing access to naloxone on commercial airlines
Delegates agreed to a policy that supports adding naloxone to airline medical kits. Although the Federal Aviation Administration mandates that commercial air carriers have onboard emergency medical kits, naloxone is not currently required.
“The AMA has been a longtime supporter of