Eye Drop Déjà Vu

HOT TOPIC

This week, the FDA issued warning letters to eight companies for violating federal law by marketing, selling, or manufacturing unapproved ophthalmic drug products. Some of the warning letters also cite the companies involved for quality issues related to product sterility. The warning comes on the heels of increased OTC drop issues, including side effects as severe as death. According to the FDA, this move is “to protect Americans from potentially harmful ophthalmic products.”

The FDA’s press release states that the products being addressed are “illegally marketed to treat conditions such as conjunctivitis (pink eye), cataracts, glaucoma, and others.” The FDA went on to state that the concern is heightened because these illegally marketed, unapproved ophthalmic drug products pose an increased risk of harm to users, as ophthalmic drugs applied to the ocular surface bypass some of the body’s natural defenses.

Of particular note is the presence of “silver” in some of the products, which could be characterized as silver sulfate, silver sulphate, or argentum. It is accepted in medicine that long-term use of drugs containing silver can cause patients to develop argyria, a condition resulting from excessive exposure to chemical compounds of the element silver that causes the skin to permanently turn gray or a blueish gray hue.

A list of the products can be found below, with the FDA stating that it was “especially concerned from a public health perspective” and the products are “not generally recognized as safe and effective (GRASE) for referenced uses and therefore are a new drug.” (Read more here.)

Boiron: Optique 1 Eye Drops

CVS Health: CVS Health Pink Eye Relief Drops

DR Vitamin Solutions: Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and Longevity Science Visual Ocuity

Natural Ophthalmics: Women’s Tear Stimulation Dry Eye Drops, Allergy Desensitization Eye Drops, Ortho-K Thin (Daytime) Eye Drops, Ortho-K Thick (Night) Eye Drops, Tear Stimulation, Forté Dry Eye Drops, and Cataract Eye Drops with Cineraria

OcluMed: OcluMed Eye Drops

Similasan AG/Similasan USA: Similasan Dry Eye Relief, Similasan Complete Eye Relief, Similasan Allergy Eye Relief, Similasan Kids Allergy Eye Relief, Similasan Red Eye Relief, Similasan Pink Eye Relief, Similasan Kids Pink Eye Relief, Similasan Aging Eye Relief, Similasan Computer Eye Relief, Similasan Stye Eye Relief, Similasan Pink Eye Nighttime Gel, Similasan Dry Eye Nighttime Gel

TRP Company: Dryness Relief, Pink Eye Relief, Allergy Eyes Relief, Red Eye Relief, Eye Strain Relief, Eye Lid Relief, Aging Eye Relief, Blur Relief, Floaters Relief, Twitching Relief, Stye Relief, Dryness Relief PF

Walgreens Boots Alliance: Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, Walgreens Pink Eye Drops

My Two Cents

Great job FDA! I can’t tell you how often I have had patients with ocular surface issues who have tried to self-medicate with these exact drops. The patients rarely improve and often state that their disease process is worse. Here’s to hoping that the FDA can use this momentum to go after all the shady direct-to-consumer contact lens companies more aggressively.

OUTSIDE THE LANE

Can an Eye-Tracking Tool Help Diagnose Autism Earlier?

As public knowledge and awareness about autism grows, the race is on to provide faster and more precise ways to diagnose the condition. Unfortunately, with current methods, many families of children on the autism spectrum face long wait times to diagnose their child. Even when that diagnosis is made, it may not be definitive.

Just a few weeks ago, twostudieswere released that suggest a rapidly developed eye-tracking tool could help doctors diagnose children as young as 16 months with autism and be more confident in that diagnosis. The developers have expressly stated that this eye-tracking–based technology is not aimed to replace clinicians, but rather the hope is that “by providing objective measurements that objectively measure the same thing in each child it can help inform the diagnostic process.”

In traditional medicine, children are diagnosed with autism based on the clinician’s assessment of their behavior, parental reports, and developmental history. EarliPoint Evaluation is cleared by the FDA to help clinicians diagnose and objectively assess autism.  

How does the technology work? EarliPoint Evaluation tracks children's eye movements as they watch videos of other children’s social interactions. A child without autism will typically focus their attention on the hand gestures of one child in the video who’s pointing toward something for another child in the video to look at. The non-autistic child may also choose to focus on the face of another child who looks sad or is actively smiling, while a child with autism would typically not pay attention to the hand gestures or facial expressions at all. Using this methodology, the studies found that the children’s eye-tracking measurements had a 71% sensitivity and 80.7% specificity. (Read more here.)

My Two Cents

Boy, this sounds a lot like an autorefractor, doesn’t it? It is a great piece of technology that we use to get an objective starting point for a diagnosis. To me, this seems like a huge leap in the ability to diagnose autism for our medical peers. According to Kristin Sohl, MD, chair of the Autism subcommittee for the American Academy of Pediatrics, this could allow children of underserved communities to benefit, as autism care is “really, really suboptimal” for them. She believes that “the equity issue in autism is very significant.”

CAN YOU RELATE  

Last weekend, I was a part of four different lectures at the MOD Live conference. One of the fun things about lecturing is seeing what information perks the audience up the most and what they genuinely seem the most interested in. This year, the information I presented that garnered the most response (by far) was on how we can help our patients who need meibomian gland expression and other dry eye treatments but can't afford them.

Simply put, many of our worst dry eye case also happen to be our most economically challenged patients. Why should only those with financial means be able to get their meibomian glands heated and expressed? During one of my lectures, I described my process for heating and expressing the glands of these patients. To do so, I use the single-use Eyedration Air Activated Steam Mask (Bruder). No microwave or any other items are needed for this. The doctor (or patient) simply opens the individual packet and puts the mask on. It slowly heats up on its own (similar to a hot hands hand warmer) and I let the patient sit in the exam room for about 15 minutes. Then I return to the room to give their glands a quick expression with a Collins expression (my favorite).

The clinic can choose to charge whatever they deem fair for the heating and expression—anywhere from a couple of bucks to a few hundred dollars—and patients genuinely appreciate the service and are ecstatic with the result. These masks can also be sold in office for patients to wear at night (obviously they would skip the expression step).

Check it out, and remember: All of our patients deserve options, no matter their financial situation!

Disclosure: I am one of the developers of the Eyedration Air Activated Steam Mask.

QUOTE OF THE WEEK

“Today is your opportunity to build the tomorrow you want.”

—Ken Poirot, Author, Entrepreneur, and Public Speaker