AOA complaint focuses FDA sights on Opternative

AOA President-elect Christopher J. Quinn, O.D., and AOA staff convened an in-depth meeting with U.S. Food and Drug Administration (FDA) officials on Nov. 4 to discuss purported online vision "exams," including Opternative.

During the meeting, a result of bipartisan Congressional interest in the expansive complaint the AOA submitted to the FDA in April 2016, Dr. Quinn and the team reinforced its serious concerns and elaborated on new and additional grounds for alarm over Opternative's online test, which claims that it yields prescriptions for eye glasses and contact lenses that are "as accurate as an in-person, refractive eye exam."

Specifically, AOA team members detailed the lack of credible evidence supporting the use of unsupervised, self-administered vision tests. The AOA also described a persistent effort by online vision tests to evade federal oversight and regulation, as well as continued, deceptive marketing tactics that mislead patients and potentially jeopardize their eye and vision health.

"It is the AOA's view that patients will incorrectly believe that these 'FDA-regulated' tests provide them with results similar to what they would get from their eye doctor, when in fact, tools like Opternative allow potentially serious eye, vision and health issues to fall through the cracks," Dr. Quinn says.

"In-person eye exams uncover the full range of vision problems, eye disease diagnosis, as well as a multitude of systemic health problems such as diabetes," he says. "Opternative's online 'exam' is no replacement for the doctor-patient relationship. The FDA is taking our concerns seriously and is investigating Opternative based on the expansive and detailed complaint AOA filed. We look forward to an ongoing dialogue with the FDA officials."

Nine representatives from the AOA and FDA met face to face at the federal agency's Silver Spring, Maryland, headquarters, and with the FDA Centers for Devices and Radiological Health (CDRH), the AOA walked through the details of its complaint, underscoring how the Opternative medical device has not delivered any credible scientific evidence that it works.

There are no peer-reviewed studies of the online device and media investigations have borne out that these online technologies are not always accurate and can miss sight-threatening and life-saving diagnoses. The team highlighted that further investigation and regulation is needed to uphold the FDA's duty to patients and the public to ensure safe and effective care, obligations already met by doctors of optometry.

Greater danger

The unapproved Opternative medical device is an even greater danger to the public than originally thought.

"The Opternative medical device is fundamentally different from any predicate device currently on the market," says Michael Dueñas, O.D., AOA chief public health officer. "It is manipulating some components of an eye exam in an unproven way and, ultimately, providing inappropriate or ineffective care is worse than providing 'no care,' as it creates a false sense of security."

The AOA's new and additional concerns? Opternative is aggressively marketing itself to high-risk populations, appealing to a desire for convenience and belittling the importance of an in-person, comprehensive eye exam.

Looking at today's combination of convenience-minded patients with an unregulated market, the AOA expressed significant concerns about the potential proliferation of copycat devices in the absence of FDA action.

With this in mind, the AOA believes that all associated risks of the Opternative medical device should be responsibly identified against benefits to help support the FDA in taking appropriate regulatory action. The FDA representatives responded that the agency is investigating: "We're looking at the science and how it can be appropriately regulated. At the end of the day, we always make decisions that are in the best interests of the patient."

AOA's continued advocacy for patients

In August, AOA Trustee and Federal Keyperson, Jim DeVleming, O.D., briefed his congressional representative, Rep. Cathy McMorris Rodgers (R-Wash.), chair of the House Republican Conference, about AOA's concerns and the complaint itself. For added impact, Dr. DeVleming was joined by Steven A. Loomis, O.D., AOA immediate past president, who oversaw the complaint's drafting and formally submitted it to FDA officials.

"Leaders of the Optometric Physicians of Washington have provided me with a copy of their complaint to the U.S. Food and Drug Administration regarding Opternative's new testing device," Congresswoman McMorris Rodgers said. "They have outlined why they see the potential for the public to be misled and why they've asked for enforcement action.

"While we must continue to support technological innovations in the medical field, the health and safety of patients should be our No. 1 priority," McMorris Rodger added. "I believe it is of the utmost importance to fully understand how the FDA intends to respond, and what actions they may take in the future to ensure compliance with the law."

Also, Peter Theo, executive director of the Wisconsin Optometric Association, and its leaders have been actively educating the public about inaccurate claims about online vision tests. Theo participated in a roundtable discussion with the Speaker of the House. Rep. Paul Ryan (R-Wis.).

Thirteen states have enacted critical patient protection laws that reinforce the benefits of in-person, comprehensive eye exams, including Georgia, Indiana, Nebraska and South Carolina among others. In October, Opternative and its legal arm, Institute for Justice, sued South Carolina in an attempt to expand their business in spite of patient safety concerns.

The AOA will continue to rally against the suit.