Quick Hits

Multiple factors spur rise in cataract surgery

Study: aging population not the only driver.

An in-depth study of one Minnesota county and its growing incidence of cataract surgery over a seven-year period contradicts the simple explanation that an aging population alone is driving increases in cataract surgery. Researchers from the Mayo Clinic used detailed and comprehensive health records of the residents of Olmstead County, Minn., to track 8,012 cataract surgeries there from 2005 through 2011. These records were available through the Rochester Epidemiology Project (REP), to which 98% of the people of Olmstead County have allowed access to their complete health records.

The Mayo Clinic researchers, led by Heidrun E. Gollogly, MD, presented their findings in a recent article in the Journal of Cataract and Refractive Surgery. The researchers combined the seven-year data from Olmstead County with longer-term data from other reliable sources such as Medicare to conclude that the incidence of cataract surgery in the United States has continued to increase over a 32-year period and shows no signs of leveling off.

As the need for cataract surgery continues to increase, the researchers assert that understanding the underlying factors for the increase should allow the development of “effective policies and procedures to manage costs and to ensure access to appropriate care.”

Aside from age, the researchers found the following factors have influenced the increase in cataract surgery in Olmstead County:

■ Second-eye surgery performed sooner and more frequently. The researchers noted studies have documented the benefits of second-eye surgery in eliminating visual disturbances that result when a patient has only unilateral cataract surgery. Second-eye surgery also improves mobility orientation and aids in avoiding falls. In the Olmstead cohort, the rate of second-eye surgery three months after the first eye more than doubled compared to the previous seven-year period.

■ Greater access to surgeons and surgical facilities. The number of cataract surgeons practicing in Olmstead County increased 27% in the past decade and an outpatient surgery center opened in the community.

■ Widening indications for cataract surgery. The researchers found that cataract surgery rates increase when indications for surgery are widened. For example, the popularity of refractive lens exchange has grown as patients seek better vision associated with newer procedures that eliminate cataracts at an early stage.

REFERENCE

Gollogly HE, Hodge DO, St Sauver JL, Erie JC. Increasing incidence of cataract surgery: population-based study. J Cataract Refract Surg 2013; 39:1383-1389.

Aerie Pharmaceuticals advances two ROCK glaucoma drugs

Company raises $68 million in stock offering.

By René Luthe, Senior Associate Editor

Aerie Pharmaceuticals (Bedminster, N.J.), developer of two glaucoma drugs currently in FDA clinical trials, has added approximately $68 million in new cash to its balance sheet as a result of a recent public stock offering. Aerie shares (NASDAQ symbol AERI) began trading at a price of $10 a share on October 25. The company will use the money to fund late-stage trials for its two lead drugs.

The company's two rho kinase (ROCK) inhibitors, AR-13324 and PG324, are dual-action and triple-action products, respectively. In addition to its ROCK activity, which regulates the proteins responsible for cellular contraction, AR-13324 inhibits norepinephrine transporter, thus AR-13324 increases outflow through the trabecular meshwork to reduce IOP, while also reducing fluid inflow. Dosage is once daily.

PG324 is a combination of the dual-action compound AR-13324 with latanoprost. According to the company, the AR-13324 in the drug can reduce the production of aqueous fluid and increase outflow, while the latanoprost increases secondary drain outflow. If approved, PG324 would be the first glaucoma drug with three distinct mechanisms to reduce IOP in one drop, dosed once daily. Both drugs are expected to move on in the FDA clinical trials process soon: AR-13324 to phase 3 to confirm efficacy and safety; and PG324 to phase 2b.

Aerie's senior leadership, led by chairman and CEO Vicente Anido Jr., PhD, has previously been involved with the development of several successful ocular drugs. The company holds worldwide rights to its products and says it will retain US rights, so it will commercialize the drug itself. According to a company prospectus, Aerie is working on developing a sales staff of approximately 100.

More evidence cataract surgery reduces mortality

Australian study is latest to support quality of outcomes.

By Bill Kekevian, Senior Associate Editor

Patients who undergo cataract removal had mortality rates 40% lower than those with visually impairing cataracts who did not have surgery, according to a study out of Australia,¹ the latest evidence documenting the benefits of the procedure.

The study collected data from the Blue Mountains Eye Study, a population-based cohort study of vision and common eye diseases. The study evaluated 354 individuals age 49 year and older and diagnosed with cataract-related vision impairment between 1992 and 2007.

“We do know that visual rehabilitation from significant visual disability (correcting 20/80 or worse acuity to 20/20) confers an overall quality-of-life gain of approximately 20%, which surpasses the mean gain in quality-of-life seen with other medical therapies such as antihypertensive agents, statins and key drugs used for osteoporosis treatment,” says Melissa Brown, MD, president and CEO of the Center for Value Based Medicine, which tracks costs of outcomes of ophthalmic procedures.

However, all studies have their limits. “Visual disabilities often are associated with depression that can confound data such as this,” Dr. Brown says. “We see a big correlation between depression and visual disabilities from AMD.”

Indeed, one of the Australian study's researchers, Jie Jin Wang, PhD, notes one limitation of the study is that participants who did not undergo cataract surgery may have had other health problems that affected their survival rates.

“I believe the main driver for whether a patient has cataract surgery is and should be their visual disability and its effect on their quality of life,” Dr. Brown says.

Dr. Brown speculates about the possibility baby boomers are considering surgery for reasons other than simply distance visual acuity. “Clearly, bilateral cataract surgery has become routine to obtain best bilateral vision,” she says. A recent Mayo Clinic study shows second-eye cataract surgery now being performed earlier and in a greater percentage of patients.²

REFERENCES

1. Fong CS, Mitchell P, Rochtchina E, Teber ET, Hong T, Wang JJ. Correction of visual impairment by cataract surgery and improved survival in older persons: the Blue Mountains Eye Study cohort. Ophthalmolgy. 2013;120:1720-1727.

2. Gollogly HE, Hodge DO, St Sauver JL, Erie JC. Increasing incidence of cataract surgery: population-based study. J Cataract Refract Surg. 2013;39:1383-1389

Intravitreal injections are not going away

They work. Alternatives have their own problems.

In recent statements, both publicly and in an interview, top scientists at both Genentech (Roche, South San Francisco, Calif.) and Regeneron (Tarrytown, N.Y.) have indicated they are not in a great hurry to replace intravitreal injections as the method by which their market-leading retina drugs are delivered to patients. Spokespeople for both companies expressed a desire to move quickly to develop combination therapies with increased duration of response that would reduce the number of intravitreal injections patients would undergo each year.

Of the two companies, Genentech has been more active in pursuing alternate methods of drug delivery. The company already has a partnership with ForSightLabs4 (Menlo Park, Calif.) to develop a sustained-release format for its anti-VEGF drug ranibizumab (Lucentis), In addition, Gary Sternberg, MD, therapeutic area head for ophthalmic medical affairs for Genentech, says “new methods of drug delivery are a high priority for us.” But Dr. Sternberg says intravitreal injections will probably be the main method of delivering retinal drugs for the next decade.

For its part, Regeneron has shown little inclination to develop a sustained-release version of its leading anti-VEGF drug aflibercept (Eylea). At an analysts' meeting this year, Michael Aberman, MD, a Regeneron spokesperson, expressed reservations about the feasibility and safety of sustained-release implants. He said studies of implant devices to date “have not been that convincing that you're really going to get much of a benefit in terms of duration with these devices.”

While companies such as pSivida (Watertown, Mass.) have had success in developing sustained-release implants for ophthalmic steroids, the fusion proteins and monoclonal antibody fragments that characterize existing anti-VEGF therapies may present a totally different challenge for sustained release, say researchers. Maintaining drug stability and keeping these drugs from degrading in an implant is considered one of the major challenges, according to Pravin Dugel, MD, of Retinal Consultants of Arizona.

Given the fact that the overwhelming majority of the millions of intravitreal anti-VEGF injections given since the advent of anti-VEGF have been done safely, it would appear that intravitreal injections will not be that easy to replace with alternate delivery methods.