Author: Healio ophthalmology

Experts say lawsuit challenging Affordable Care Act could kill it

Arthur Caplan Robert Greenwald  
Attempts to eliminate the Affordable Care Act have taken a new turn. Nearly two dozen states or their governors have filed a lawsuit against the United States government, HHS, IRS and several others claiming that Congressional action that lowered the tax on those who did not comply with the individual mandate to buy insurance voids the Affordable Care Act.
The new lawsuit, known as Texas v. the United States (2018), has some experts and medical societies concerned about its ramifications. According to AMA, the Trump (Read more...)

LumiThera LT-300 granted CE mark for treating dry AMD

The European Union has granted a CE mark for the LT-300 light delivery system, a treatment device for dry age-related macular degeneration, LumiThera announced in a press release.
“The CE mark allows LumiThera to begin commercialization throughout the 28 EU member states and coincides with the initiation of the LIGHTSITE II clinical study in select European sites in the upcoming months,” Clark Tedford, PhD, LumiThera president and CEO, said in the release. “We are excited to be able to offer a safe and effective early-stage clinical intervention for patients with (Read more...)

FDA approves iStent inject

The iStent inject trabecular micro-bypass system has received premarket approval from the FDA for the reduction of IOP, Glaukos announced in a press release.The approval is based on a pivotal, prospective, randomized, multicenter study of 505 mild to m…

VIDEO: Combination MIGS

KIAWAH ISLAND, S.C. – At the Kiawah Eye meeting, OSN Glaucoma Board Member Savak “Sev” Teymoorian, MD, MBA, talks about tailoring glaucoma care by targeting different anatomical sites and combining minimally invasive glaucoma surgery procedures.

VIDEO: Canal-based glaucoma surgery

KIAWAH ISLAND, S.C. – At the Kiawah Eye meeting, OSN Glaucoma Section Editor Thomas W. Samuelson, MD, discusses canal -based glaucoma procedures, highlighting two new minimally invasive glaucoma surgery devices pending FDA approval, the Glaukos second generation iStent inject and the Ivantis Hydrus.

Acucela’s oral DR formulation shows potential to reduce retinal thickness

Oral emixustat hydrochloride reduced central subfield retinal thickness more than placebo in patients with proliferative diabetic retinopathy, with and without macular edema, Acucela announced in a press release.
The randomized, placebo-controlled, phase 2 trial enrolled 24 subjects to receive placebo or the study drug, titrated up to 40 mg per day. Patients in the study group experienced a mean reduction in central subfield thickness of 48.1 µm (P = .0764), as well as a mean reduction in total macular volume (P = .0263), compared with placebo.
“We are thrilled to (Read more...)

Telling it like it is about cataract surgery with no restrictions

Robert H. Osher
The ninth annual Cataract Surgery: Telling It Like It Is meeting will provide top-quality, uncensored, cutting-edge education to ophthalmologists unrestricted by current CME guidelines.
The meeting will be held Feb. 6-10, 2019, at Disney’s Yacht and Beach Club Resort in Lake Buena Vista, Florida.
Uncensored education
The meeting will feature more than 40 faculty members, comprised of some of the most talented ophthalmologists from around the world. These teachers will provide attendees with instructional materials at introductory, intermediate and advanced levels to ensure

VIDEO: Visual outcomes of an EDOF toric IOL targeted for emmetropia or nanovision

KIAWAH ISLAND, S.C. – At the Kiawah Eye meeting here, Kerry D. Solomon, MD, compares visual outcomes, patient satisfaction and visual disturbances in patients undergoing routine cataract surgery and implantation of an extended depth of focus toric IOL when both eyes are targeted for emmetropia and the non-dominant eye is targeted for nanovision.  

Kala plans advancement of dry eye treatment

Kala Pharmaceuticals plans to submit a new drug application to the FDA this year for a formulation of a short-term treatment for dry eye disease, according to a company press release.
KPI-121 0.25% is being investigated as a 2-week course of therapy intended for the temporary relief of the signs and symptoms of dry eye. The formulation uses “Kala’s mucus-penetrating particle (MPP) technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the eye,” the release said.
Data from one phase 2 trial and two phase 3 efficacy (Read more...)

FDA lifts warning letter against STAAR Surgical

The FDA has issued a close-out letter to STAAR Surgical, lifting a 2014 warning regarding the manufacture of Visian Implantable Collamer Lens devices, the company announced in a press release.
The FDA action is a result of “a comprehensive remediation program” that addresses the issues raised by the FDA and includes “assessment, remediation and upgrade of all aspects of STAAR’s quality systems to assure compliance with Quality System Regulations (QSR),” Caren Mason, president and CEO of STAAR, said.
The initial warning letter, issued May 21, 2014, listed multiple

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...)

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...)