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Solid PR release on glaucoma device should’ve cautioned on study limitations

Silicone ring that rests on the eye releases medication slowly over six months, could help lower risk of vision loss among seniors with the disease

SAN FRANCISCO, May 5, 2016 /PRNewswire-USNewswire/ — A new device that slowly releases eye medication may one day be a promising option for the many glaucoma patients who struggle with administering their own daily prescription eye drops. New research shows a medicated silicone ring that rests on the surface of the eye reduced eye pressure in glaucoma patients by about 20 percent over six months. The first published research about this continuous glaucoma drug delivery technology was released online today in Ophthalmology, the journal of the American Academy of Ophthalmology.

Despite the availability of effective therapies, glaucoma remains a leading cause of blindness. Nearly 3 million people in the United States have the condition. It is often marked by elevated internal eye pressure, called intraocular pressure. Medicated eye drops taken daily or twice daily can lower internal eye pressure to help prevent damage to the optic nerve. But studies show that many patients do not take glaucoma eye drops as directed due to factors such as forgetfulness or physical limitations like arthritis.1 Some studies show that half of patients stop taking their prescription glaucoma eye drops after a year, leaving them vulnerable to vision loss.2

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Researchers are tackling this challenge of medication adherence with new drug delivery methods. One technology involves a thin silicone ring suffused with medication that slowly releases over time. An ophthalmologist fits the patient with the ring. No surgery is required. The ring is designed to be replaced by an ophthalmologist every six months. This eliminates the need for glaucoma patients to regularly put in medicated eye drops themselves.

Ophthalmologists at 10 sites nationwide tested the ring in a phase 2 clinical trial on patients with glaucoma or ocular hypertension. In the study, 64 patients received the topical ocular insert containing the glaucoma drug bimatoprost. They were also supplied artificial tears. The control group of 66 patients wore an insert treated with no drug but twice a day used 0.5 percent timolol drops, the regulatory benchmark for glaucoma drugs. Eye pressure in the bimatoprost group fell 3.2 to 6.4 mmHg over six months, in comparison to 4.2 to 6.4 mmHG for the timolol group. Overall, eye pressure decreased in the group wearing the bimatoprost ring by about 20 percent from the initial measurements over six months.

Authors said the device was well-tolerated and safe, with a high retention rate of 89 percent for both groups at six months. The ring became dislodged in 15 patients but was replaced each time, allowing therapy to continue. Some patients experienced itchiness and eye redness, which is not unusual for patients taking glaucoma medication.

“In making effective treatments easier for patients, the hope is that we can reduce vision loss from glaucoma, and possibly other diseases,” said study author James D. Brandt, M.D., director of the UC Davis Medical Center Glaucoma Service. “What is exciting is that this is just one of several sustained-release drug delivery methods designed to help patients who have trouble taking daily eye drops.”

A phase 3 study of a larger group of patients is expected to begin later in 2016. The authors noted the device could also be used for non-glaucoma medications, with potential applications for dry eye, allergies and inflammation. In addition, the non-invasive nature of the device and its relatively large surface area make this technology a potential candidate for delivering multiple ocular drugs at once, further reducing the burden of self-administration on patients.

Six-month IOP Reduction with a Topical Bimatoprost Ocular Insert: Results of a Phase 2 Randomized Controlled Study,” Brandt, et al. Ophthalmology, article in press, May 2016. DOI: 10.1016/j.ophtha.2016.04.026. The results are also being presented today at the Ophthalmology Innovation Summit in New Orleans. The authors receive financial support from ForSight VISION5, manufacturer of the bimatoprost ring.

For more information on glaucoma, visit the American Academy of Ophthalmology’s EyeSmart® public information website, www.aao.org/eye-health.

About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest membership association of eye physicians and surgeons. A global community of 32,000 ophthalmologists, we are passionate about protecting sight and fighting preventable blindness. For more than 120 years, we have been educators, innovators and advocates for the public and our profession to ensure the highest-quality medical and surgical eye care. Our EyeSmart® program is a preeminent source of eye health information for the public and empowers people to preserve their vision. For more information, visit www.aao.org.

About Ophthalmology
Ophthalmology, the official journal of the American Academy of Ophthalmology, publishes original, peer-reviewed, clinically-applicable research. Topics include the results of clinical trials, new diagnostic and surgical techniques, treatment methods, technology assessments, translational science reviews and editorials. For more information, visit www.aaojournal.org.

1 Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up, Newman-Casey, et al. Ophthalmology, 2015.
2 Adherence and persistence with glaucoma therapy, Schwartz, et al, Survey of Ophthalmology, Nov. 2008

 

Video – http://origin-qps.onstreammedia.com/origin/multivu_archive/PRNA/ENR/AAO-Bimatoprost-Ocular-Insert-Demo.mp4
Photo – http://photos.prnewswire.com/prnh/20160504/363904
Logo – http://photos.prnewswire.com/prnh/20151114/287412LOGO

 

SOURCE American Academy of Ophthalmology

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Glaucoma Drug-Dispensing Eye Insert Shows Promise as New Option for Patients Struggling to Take Daily Prescription Eye Drops

Our Review Summary

Detail of woman's faceThis news release reports phase 2 trial results of a silicone ring that slowly releases glaucoma medication onto the surface of the eye, potentially eliminating the need for patients to self-administer eye drops. The study was funded by the developer of the device, ForSight VISION5, and appeared in Ophthalmology, the journal of the American Academy of Ophthalmology. Glaucoma medications work by reducing internal fluid pressure that could permanently damage the optic nerve, resulting in vision loss. This randomized controlled trial of 130 patients, 64 of whom were given a medicated ring dispensing the drug bimatroprost along with artificial tears, showed the device lowered eye pressure in glaucoma patients by about 20 percent over six months. We found the news release adequately addresses potential harms and conflicts of interest, but could have done a better job discussing costs, study limitations, and alternative approaches to improve treatment delivery.

 

Why This Matters

Patient non-adherence to glaucoma treatment regimens is a serious problem, believed to contribute to glaucoma remaining a leading cause of blindness. Medication to lower eye pressure is generally preferred over traditional surgery and laser surgery because it has fewer risks and lower costs. But many patients fail to take daily eye drops for a variety of reasons including side effects, lack of understanding about the disease, and physical difficulties. These roadblocks are compounded in older patients who have physical and cognitive impairments. Consistent treatment is critical because even short periods without medication can result in vision loss. A number of strategies have been recommended to increase patient adherence including simplifying drug regimens and improving patient communication. There’s urgency to improve treatment options. From 2010 to 2050, the number of people in the U.S. with glaucoma is expected to increase by more than double, from 2.7 million to 6.3 million, according to the National Eye Institute.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The news release doesn’t mention costs, despite the fact that investors would need to recoup the enormous cost of developing a device and winning Food and Drug Administration approval. It might be too early to estimate the market price of the ring, but the news release could have helped readers understand financial implications by mentioning the typical high cost of new medical devices as well as what it might cost to pay a clinician to insert, monitor and replace a medicated ring at regular intervals. It could have also mentioned costs for existing treatment options, and in more rare cases, the cost of surgeries that are performed when patients fail to adhere to treatment plans.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The news release states that the ring containing the drug bimatoprose reduced eye pressure in glaucoma patients by about 20 percent over six months, and eye pressure fell 3.2 to 6.4 mmHg, compared with 4.2 to 6.4 mmHG for the group taking standard eye drops. The news release could have given more context to these numbers to help readers understand what they mean in terms of patient outcomes.

It’s worth mentioning that reducing intraocular pressure is an intermediate outcome. The real goal is to slow vision loss. While this trial is too short for that, it could have been mentioned when discussing future trials that the real goal is yet to be studied. We won’t dock points for that omission here since we address it below under the “Evidence” criterion.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The news release quotes the authors saying the device is “well-tolerated and safe” with a retention rate of 89 percent at six months. It also pointed out that some patients experienced itchiness and redness, which it describes as common adverse effects for patients taking glaucoma medication, and that the ring became dislodged in 15 patients, requiring it be replaced so therapy could continue.

While the release adequately covers the known risks, in a study this small it would be good to remind readers that the device has not yet been tested on a large and diverse group of patients who might have different results. We also wonder how the ring would work in practice. Would patients who have difficulty following a treatment regimen in the first place be prompt about getting to a physician’s office promptly to have a ring replaced?

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The news release carries an overall cautious tone in reporting on the small study, but it becomes less informative than it could be by excluding a discussion of the study limitations.

The release does not address limitations of this phase 2 trial, which was designed to determine whether the device could achieve a short-term reduction in eye pressure in a few select patients rather than whether it would actually slow vision loss in a broad and diverse population over the long-term. Study participants agreed to adhere to a twice-daily regimen of either medicated or artificial eye drops, whereas the intent of the insert is to help patients who aren’t able to adhere to a daily eye drop routine. The phase 2 study was also limited to six months, while glaucoma treatment is typically lifelong. As the study says, long-term studies with a high-risk populations are required “to demonstrate the full usefulness” of the ring in preserving eyesight, but such studies “will require several years of follow-up and currently and currently are not feasible at this stage of development.” It adds that a real word long-term observational registry can be done only after the product is approved and available to physicians and patients.

Also, the news release says study authors believe the ring could be used for non-glaucoma medication “with potential applications for dry eye, allergies and inflammation” as well as for “delivering multiple ocular drugs at once.” Those are interesting ideas, but there’s no data to back them up.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release states that the authors of the study receive financial support from ForSight VISION5, which makes the ring.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The news release does not compare the ring with existing approaches to help patients adhere to treatment plans, such as better physician-patient communication and simplified drug regimens. It also gives a quote from a study author saying, “What is exciting is that this is just one of several sustained-release drug delivery methods designed to help patients who have trouble taking daily eye drops.” But there’s no elaboration to explain what these other methods are or whether they have been studied or approved for use in glaucoma patients.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The new release accurately states says the device “may one day be a promising option” for patients who struggle with administering eye drops, though it could give readers a better sense of just how far off that day might be. The news release says a phase 3 trial of larger groups of patients is expected to begin this year, but does explain how long that would take or mention the lengthy process required to win approval from the Food and Drug Administration.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release does not seem to make any unfounded claims about the novelty of this device. In fact, it quotes a study author as saying that the device “is just one of several sustained-release drug delivery methods designed to help patients who have trouble taking daily eye drops.”

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release states that the device “may one day be a promising option” for glaucoma patients who struggle with eye drops without mentioning the obvious corollary that it may not do that. However, the article otherwise does not engage in sensational language.

Total Score: 7 of 10 Satisfactory

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