Quick Hits

Ophthalmology and ODs in joint effort

Two organizations to plan for growing demands for eye care.

The American Academy of Ophthalmology and the American Academy of Optometry have initiated a joint initiative to work together to develop a cooperative approach to deliver superior services to the growing number of aging and newly insured patients in the United States who are now — or will soon — be in need of professional eye-care services.

The cooperative effort marks a positive change from the numerous scope-of-practice “turf wars” that have characterized the two groups' relationships over the past decade.

In a joint news release, the two organizations say the effort marks the first large-scale, organized effort within optometry and ophthalmology in support of joint educational initiatives.

By working together, the two organizations anticipate positioning themselves to better assist their respective members in efficiently managing the rapidly growing demand for eye care due to many chronic eye diseases increasing in prevalence in the United States due to the aging baby boomer population.

They also expect that health-care reform will result in a significant increase in the number of Americans seeking eye care.

“More and more ophthalmologists are practicing with optometrists in the same point-of-care environment and are seeking information and models that will optimize the impact for patients,” says David W. Parke II, MD, CEO of the American Academy of Ophthalmology. “The better prepared our two professions are and the more effectively they work together, the better care we will be able to provide for all patients.”

“The professions of optometry and ophthalmology complement each other in many ways,” says Bernard J. Dolan, OD, MS, president of the American Academy of Optometry. “It is refreshing to embark on this cooperative initiative in the area of continuing education to improve patient care in a collegial environment of mutual respect.”

The academies are jointly informing their respective members of this collaborative strategic effort and to obtain feedback as they begin to cooperate in developing educational opportunities. The organizations anticipate these programs will be developed over the next 12 to 18 months with a formal launch in 2015.

Abbott ends development Of Synchrony IOL

Lens stalled in FDA approval process.

By David Chang, MD, with Jerry Helzner, Senior Editor

When Abbott Labs (Abbott Park, Ill.) paid $400 million to acquire IOL developer Visiogen for its Abbott Medical Optics (AMO) division in the late summer of 2009, American ophthalmologists were eagerly hoping for approval of a next-generation accommodating IOL. After all, Visiogen's Synchrony dual-optic accommodative IOL, had just completed its US clinical trials and had also received the CE mark in Europe earlier that year. The Synchrony looked to be a strong addition to enhance AMO's future positioning in the emerging premium IOL marketplace.

Now, more than four years later, American patients will not have access to this technology for the foreseeable future as the FDA did not approve Synchrony as an accommodating IOL. Reaction to the Visiogen acquisition was almost unanimously positive when it was first announced. At the time, the Synchrony was considered a “next-generation” accommodating IOL. Visiogen had designed the Synchrony “to mimic the eye's natural capacity to change focus, with the potential to deliver a full range of vision.” Synchrony had already been implanted in more than 1,200 eyes worldwide, with excellent clinical results.

Unfortunately, the Synchrony got stalled in the FDA approval process for three years and recently Abbott decided to do a scheduled sunset of the Synchrony Vu platform in Europe, which is a different model that was evaluated in the FDA clinical trial. The company issued the following brief statement in response to a question from this publication:

“Abbott has discontinued the Synchrony vu IOL and is focusing resources on next-generation technologies. Abbott remains committed to developing and providing the best options in accommodative, multifocal and extended depth of focus lenses.”

I served as medical monitor for the Synchrony's US trials. When asked why I thought the Synchrony never got through the FDA approval process, I said that without the benefit of an FDA panel presentation, it is hard to fully understand what the specific objections were.

One of the main problems is that the burden of proving true accommodation has become very difficult. Because there were no universally accepted standards for proving accommodation with an IOL, this made it very difficult for manufacturers to design their studies and diagnostic testing, and the criteria have certainly changed since the Crystalens (Bausch + Lomb) was approved in 2004.

With the Synchrony now out of the picture, other accommodating IOLs, such as the Fluid Vision (Power Vision, Santa Barbara, Calif.) appear to be years away from approval. Another promising IOL, the Calhoun Light-Adjustable Lens (Calhoun Vision, Pasadena, Calif.) is in phase 3 of its FDA clinical trial.

Dr. Chang is a cataract surgeon based in Los Altos, Calif. He is a consultant for AMO and donates his consulting fees to Project Vision and the Himalayan Cataract Project.

Diabetes patients often Not informed of eye risks

Wilmer study finds awareness of DME, DR is low.

By Bill Kekevian, Senior Associate Editor

For ophthalmologists, emphasizing the risk of eye diseases such as diabetic macular edema (DME) or diabetic retinopathy to patients with diabetes is a given. But is the same true in the primary care community? Sadly, it is not, according to a recent study from the Wilmer Eye Institute of Johns Hopkins University.

The study, led by Neil M. Bressler, MD, retina division chief at Wilmer, showed fewer than half of the patients with diabetes polled had been informed by their doctor that diabetes could affect their vision. Despite dramatic improvement in the treatment of DME, the team's conclusion states, “Many persons with diabetes mellitus in the United States are not getting care that can prevent visual impairment and blindness. Strategies to increase awareness are warranted, especially given the recent availability of improved therapies for DME.”

The study uncovered other concerns:

• More than 40% of adults with diabetes had not received an annual retinal eye examination with pupil dilation in the last year.
• 28.7% of patients who did not know they had developed DME were already experiencing visual impairment (defined as visual acuity worse than 20/40 in the eye with DME).

The study, supported by a grant from Genentech, looked at survey data, including patient questionnaires and physical exams, from 798 participants who had self-reported diabetes. In 2010, only 44.7% of US adults (40 years or older) with DME reported a physician telling them that diabetes had affected their eyes or that they had retinopathy. The study found diabetic retinopathy without DME in 238 of those patients, while DME was found in 48.

REFERENCE:

Bressler NM, Varma R, , Doan Q, et al, Underuse of the health care system by persons with diabetes mellitus and diabetic macular edema in the United States, JAMA Ophthalmology, 2013:dpi:10.1001/jamaophthalmol.2013.6426

Amakem claims advantage In ROCK trial data

Company says its drug did not cause eye redness in clinical trials.

With almost all of the leading glaucoma medications having been in use for more than a decade, glaucoma specialists have shown great interest in a new class of drugs called rho kinase (ROCK) inhibitors. ROCK drugs offer a new, multi-faceted approach to combating glaucoma, with the most important being increasing aqueous outflow through the trabecular meshwork.

Amakem Therapeutics (Bioville, Belgium) recently announced results from its first two early-stage human trials. One key finding from a multicenter, placebo-controlled, dose-escalation study was that the group receiving the Amakem drug AMA0076 achieved a decrease in mean diurnal IOP from baseline of 3.7 mm Hg at the end of treatment.

Though Amakem is still in early-stage human trials, it has already claimed an advantage on the issue of hyperemia (eye redness). Amakem noted that AMA0076 “has been designed to reduce intraocular pressure while minimizing side effects such as hyperemia that have been observed with all other ROCK inhibitors so far tested clinically.”