Opternative

The eyeglass prescription process is the latest health care service to be disrupted — and now optometrists are waging an all-out war against a startup that lets people do vision tests without looking away from their laptops.

Less than a year ago, Opternative, a Chicago startup, began serving customers through its website. In that time, optometrist lobbying groups have successfully backed legislation that bans the company’s ability to operate in five states, including Georgia as of yesterday. Last month, the American Optometric Association complained to the Food and Drug Administration that the company's service should be taken off the market and studied because it is allegedly operating without federal approval. In the same breath, the group likened startups like Opternative to the “corporate equivalents of snake oil salesmen.”

Opternative has not proven that its technology works as advertised, optometrists argue. Eye diseases and other important conditions can languish undetected when people don’t visit optometrists in the the flesh.

But Opternative’s executives say they’re really up against a by-now-familiar startup dilemma: an industry out of touch with technology and scared of losing customers to a cheaper, better service.

“It’s no different than Uber-versus-taxis and Airbnb-versus-the hotel industry,” CEO and co-founder Aaron Dallek told BuzzFeed News. “These are entrenched interests that do not want consumers to have access to convenient, affordable eye care, plain and simple. They’re afraid of competing with our solution and that’s the bottom line.”

As Opternative has opened in 32 states, it’s learning that doing things differently can be difficult when it comes to health care and medical devices. It’s an ultra-regulated realm for good reason: at stake are the lives of people who often lack the expertise to independently judge if a product works. Privately held startups like 23andMe, Lumosity, Zenefits, and Theranos have learned similar lessons in the last few years. Last month, drug-delivery service PillPack launched a public relations blitz against Express Scripts, a pharmacy benefits manager that planned to drop it from its network. (The parties later made up, and PillPack rejoined the fold.) Similarly, hearing device manufacturers are under pressure from consumer tech companies that are making cheaper, easier-to-obtain hearing aids.

So Opternative isn’t the only health-tech startup — or even the only startup doing tech-enabled vision exams — to run into regulatory hurdles. And it likely won’t be the last, either.

Opternative

About six years ago, Dr. Steven Lee, an optometrist in the Chicago area, came up with the idea for Opternative when a patient asked him why the exam couldn’t be done at home. But while patients are increasingly using their smartphones to ask doctors about acne, fevers, and light injuries — and though more than 21 million American adults have vision trouble, according to the Centers for Disease Control and Prevention — Lee had a hard time finding others who shared his enthusiasm.

Then, at a party, Lee made his pitch on Dallek, a lifetime glasses- and contacts-wearer who’d co-founded several businesses. The pair founded Opternative in 2012, raised $9 million, and started serving customers in late July.

To take Opternative’s 25-minute test, customers stand at a distance from the computer, look at words and images on its website, and punch in answers on a smartphone app. The results are reviewed on the other end by an ophthalmologist licensed in the customer’s state. For $40 (the test isn’t covered by insurance), customers get a prescription within 24 hours that they can use anywhere.

Dallek said the company largely relies on a “very advanced algorithm” that identifies nearsightedness and other refractive errors, as well as if it’s appropriate for a patient to get a prescription. Dissatisfied customers can get a fixed prescription or a refund. “In many ways it’s just like in the doctor’s office,” Dallek said. “You’re going to the exam, and if there are inconsistencies in the results, either we get a retake of the exam, recollect that information from the patient, or we would then recommend the patient go see someone in person.”

More than 55,000 people have registered to take the test, which by itself is free, although Dallek declined to say how many have taken the extra step of paying for a prescription. He said that the customer satisfaction rate is 99 percent.

As proof of the test’s efficacy, Opternative points to an independently run clinical trial that put 30 people through both Opternative’s test and a traditional vision exam. The two sets of prescriptions and self-reported satisfaction rates were on par with each other, according to the study, which has not been published in a peer-reviewed scientific journal. Dallek said the company is planning to conduct and publish a larger clinical trial.

Dallek also noted that Opternative has not faced any resistance from the American Academy of Ophthalmology.

Founders Aaron Dallek and Dr. Steven Lee

Sean Su / Opternative

But in the eyes of Dr. Steven Loomis, a sample size of 30 people is simply too small to support the conclusion that the service works. Loomis, the president of the American Optometric Association, says that focusing on just the prescription leaves out crucial health information.

Just before hopping on the phone with BuzzFeed News last week, he saw a patient with a changed prescription — “but it wasn’t really just a change in his prescription, he had a cataract,” Loomis said. “And I can tell by the amount of change in the prescription, I think that that might be what’s going on.” Other patients find out in appointments that their vision is fluctuating due to an onset of diabetes and other diseases, he said.

Opternative customers must be healthy and between 18 and 40, and the company warns that it “is not a replacement for a comprehensive eye health exam.” But Loomis worries that customers will still mistakenly believe they’ve had such an exam.

In its complaint filed with the FDA, the American Optometric Association alleges that Opternative has not proven that its technology is equivalent to products already on the market, as the FDA requires, and is therefore operating unlawfully. Dallek rejects that argument. “We’ve had contact with the FDA prior to launching, and so we feel we are following the guidance that they give us,” he told BuzzFeed News.

As a lobbying force, optometrists have gone hard after Opternative on the state and federal level. Laws intended to block Opternative’s form of service have been passed in Indiana, Oklahoma, Nebraska, Georgia, and Michigan, which slapped the startup with a cease-and-desist order in February after the state optometrists group filed a complaint. (Dallek believes that the company will ultimately be able to operate in Nebraska and Michigan, given how those laws are written, and is reviewing the law that Georgia's governor signed yesterday.) Similar legislation is pending in South Carolina and Minnesota.

Optometrist groups have moved with striking swiftness, considering their foe has been doling out prescriptions for less than a year. “It’s an aggressive reaction,” Loomis said, “because we’re concerned about patient safety.”

Opternative employees at work.

Opternative

Opternative isn’t the first vision-exam startup to have received a less-than-warm welcome. In April 2015, Blink officially launched a service in which technicians visited people’s homes in New York City and used portable equipment to write them prescriptions on the spot. In July, the New York State Optometric Association and the New York Board of Optometry complained. Not long after, the New York Education Department and its Office of Professional Discipline began investigating Blink and its parent company, EyeNetra. (A department spokesperson said the investigation is still ongoing.)

EyeNetra co-founder Vitor Pamplona told BuzzFeed News that the service has been suspended, but not shut down. Depending on how the investigation plays out, the startup could face hefty fees for the 10,000 people it served before the suspension went into effect in July. If their prescriptions are found invalid, the company may have to make up for them by footing the bill for additional vision exams, Pamplona said.

“This would definitely create many issues if all those 10,000 people end up being legal cases for us,” he said.

In the meantime, EyeNetra has been selling its portable eyesight-measuring devices, spun out of the Massachusetts Institute of Technology, to other companies to use. Among them is Pupil, a newly launched startup that sends technicians to conduct in-home vision exams — which is pretty much exactly what Blink was doing.

So is Pupil co-founder Logan Beck worried about meeting Blink’s fate, too? He said that Pupil is compliant with the law in Colorado, which is the only place it’s operating right now.

Pupil has only been up and running for a few weeks, but Beck’s glimpse at the health-tech startup world has already instilled in him one noteworthy goal: “Partner with optometrists and expand the reach of optometry, instead of insulting them and making them feel like we’re taking market share.”

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