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FDA Issues Warning Letter to Opternative

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The firm’s app lacks the required approval.

The U.S. Food and Drug Administration has issued a warning letter to Opternative for marketing its eye exam mobile app “without marketing clearance or approval.”

The agency requested that the company “immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.”

The letter was dated Oct. 30, 2017, and posted online last week.

The app is a device “because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body,” according to the agency.

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The letter instructed Opternative to respond within 15 days explaining how it would correct the violations described in the letter. Failure to correct the alleged violations could result in actions such as seizure, injunction and assessment of civil monetary penalties, according to FDA.

Buzzfeed News quoted Opternative’s Peter Horkan saying, “We have responded to the Warning Letter and we are working closely with FDA on this matter.”

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Eye Health Firm Plans Job Cuts

It will focus resources on Dextenza.

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BEDFORD, MA — Ocular Therapeutix Inc., a biopharmaceutical company focused on therapies for eye conditions and diseases, announced an operational restructuring plan.

The plan is expected to result in about $11 million in annualized savings through personnel reductions and $14 million in “one-time program deferrals,” according to a press release. The company did not say how many jobs would be cut.

With the restructuring, the company is looking to focus resources on Dextenza, an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.

“We have elected to restructure Ocular in order to maximize the opportunity we have with DEXTENZA and our pipeline,” said Antony Mattessich, president and CEO. “We will use a portion of the savings generated to increase the size of our commercial field force to broaden our national reach and increase DEXTENZA promotional capabilities. Additionally, the savings are anticipated to extend our cash runway through the end of 2020 and provide an improved financial position as we build the Company for the long term.”

According to the press release:

The restructuring represents a strategic realignment and commitment by the Company to allocate capital and resources to maximize the commercial opportunity of DEXTENZA® and focus resources on progressing key pipeline assets, including completion of its DEXTENZA Phase 3 trial in allergic conjunctivitis and completion of Phase 1 trials of OTX-TIC for the treatment of glaucoma and ocular hypertension and OTX-TKI for the treatment of wet age-related macular degeneration. The Company believes the savings, combined with projected sales of DEXTENZA and cash and cash equivalents, will result in an extension of the Company’s current cash runway through the fourth quarter of 2020.

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FTC Releases Disclosures Guidance for Social Media Influencers

It explains when and how influencers must disclose sponsorships to their followers.

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Enlisting social media “influencers” has become a popular way to promote a wide range of products, including eyewear.

Unfortunately, it’s not always obvious to consumers what is and isn’t an ad. The Federal Trade Commission wants to fix that.

The FTC has released a new publication for online influencers that lays out the agency’s rules of the road for when and how influencers must disclose sponsorships to their followers.

The new guide, “Disclosures 101 for Social Media Influencers,” provides influencers with tips from FTC staff about what triggers the need for a disclosure and offers examples of both effective and ineffective disclosures.

The guide and accompanying videos underscore that the responsibility to make disclosures about endorsements lies with the influencer. The guide outlines the various ways that an influencer’s relationship with a brand would make disclosures necessary, and it reminds influencers that they cannot assume that followers are aware of their connections to brands.

The guide includes tips for when and how influencers should tell their followers about a relationship. For example, it suggests the words influencers might use, as well as where in their social posts a disclosure should appear.

The new publication summarizes the FTC’s existing guidance in this area, including the FTC’s Endorsement Guides and a 2017 question-and-answer document produced by staff.

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$17M Grant to Support Research Linking Eye Health, Alzheimer’s

‘The eyes provide a lens to understand the health of the brain,’ says one researcher.

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(Press Release) In pursuit of changing the course of Alzheimer’s, support is growing to explore new avenues that might unlock mysteries of this brain disease. This includes investigating the link between aging eyes and aging brains.

Cecilia Lee, an assistant professor of ophthalmology at the University of Washington School of Medicine, recently received a $17.2 million grant from the National Institute on Aging to research eye diseases’ associations with Alzheimer’s.

“The eyes provide a lens to understand the health of the brain,” she said.

Lee was lead author of a 2018 study that found a significant link between Alzheimer’s disease and three degenerative eye diseases: age-related macular degeneration, diabetic retinopathy and glaucoma.

Alzheimer’s is complicated and expensive to diagnose. Lee hopes to identify novel eye-related biomarkers for Alzheimer’s disease that could lead to much easier and cheaper diagnostics to pinpoint people at risk of developing dementia due to Alzheimer’s, and perhaps expedite future treatments.

The research team comprises a large group of UW and Kaiser Permanente Washington Health Research Institute investigators with world-renowned expertise in dementia, neuropsychology, neuroimaging, ophthalmic imaging, big data, and artificial intelligence. They include Eric B. Larson, senior investigator and former vice president for research and healthcare innovation at Kaiser, and, from the UW: Paul Crane, professor of medicine, C. Dirk Keene, associate professor of pathology, Ruikang Wang, professor of bioengineering, and Aaron Lee, assistant professor of ophthalmology.

In 1994, while at the University of Washington, Larson started the Adult Changes in Thought (ACT) study, a prospective repository of health information of Kaiser Permanente Washington patients age 65 and over; it provides data for many studies, including this one. The ACT database also includes a rare autopsy cohort so researchers can see what happened to the brains of consenting participants after they die. The team will partner with the Laboratory on Neuro Imaging at the University of Southern California to make the ophthalmic imaging data from this project available to researchers around the world.

“This project will develop unique community-based and home-based data about the health of eyes in older adults, which has never been studied to this extent before,” said Crane. “It will be the largest such collection of data from any project anywhere, which is very exciting.”

Keene said the study is important because linking disease processes in the eye and the brain provides a window not only for diagnosis but also to understand mechanisms of Alzheimer’s disease development and progression.

“This will hopefully result in early intervention and prevention of neurodegeneration,” he said.

Lee said the grant is an endorsement of the ACT team’s work and of the National Institute on Aging’s investment in Alzheimer’s research involving the eye. As Larson said, the ACT team has had longstanding interest in the relationship of sensory functions with Alzheimer’s, but now they have much more sophistication and promise to understand it.

Credit: UW Medicine

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