Eyenovia Celebrates First FDA Approval

HOT TOPIC

The FDA has accepted Eyenovia’s New Drug Application (NDA) for MydCombi, its product candidate for inducing mydriasis for diagnostic procedures and conditions where short-term pupil dilation is warranted.

MydCombi is a fixed combination of tropicamide 1.0% and phenylephrine 2.5%, which are used to dilate the pupil and represent the first approved fixed-dose combination of these two drugs in the United States. Combining these medications provides rapid and sustained pupil dilation, eliminating the need for multiple eye drops. MydCombi is contraindicated and should not be used in patients with known hypersensitivity to any component of the formulation.

The FDA had set a Prescription Drug User Fee Act (PDUFA) target action date of May 8th. If approved, MydCombi would be the first product using the clinical-stage ophthalmic biopharmaceutical company’s propriety Optejet device.

OUTSIDE THE LANE

On the Injured List Due to Dry Eye

New York Mets catcher Tomás Nido was recently placed on a 10-day injured list due to dry eye syndrome. 

Nido has been experiencing symptoms of dry eye syndrome for several weeks and has been using numerous eye drops in an attempt to manage the condition. However, the Mets decided to place Nido on the injured list to give him time to recover fully. “He just needs to get [the vision] corrected,” manager Buck Showalter said before the Mets beat the Reds 2–1. “We have got some people that feel they can help him, and if it was an infielder where you thought you could get through the next 3 or 4 days … obviously with catcher, I know we were thinking about pinch-running [Tuesday] night, and I didn’t feel comfortable with him in the game.” Showalter said he expects Nido’s issue to be resolved within 3 or 4 days.

My Two Cents

I’ve shared this story with countless patients, as it’s good for them to understand that dry eye syndrome affects millions of people, including professional athletes. Dry eye syndrome is a disease—and one that can be improved with proper care!

CAN YOU RELATE

I recently had a patient come in for a scleral lens fitting. At his initial visit a few weeks prior, before any hands were shaken or formal introductions were made, he said, “I need to warn you about me, doctor. I ask a lot of questions.” I joked that this was totally understandable, told him I love questions, and even kiddingly challenged him to try to stump me on the specialty lens or dry eye space.

As the exam continued, it became clear as to why he’s “never found his forever eye doctor” and “never had a good exam at the eye doctor.” After about an hour of rapid-fire Q&A, a general eye exam, an explanation of his Pentacam images, and an overview of keratoconus and how scleral lenses will help him, we went our separate ways. Not before, however, I gave him my scleral lens patient handouts, including a roughly 20-page document with the most common questions thoroughly answered.

Fast forward to his fitting. Insurance has approved the lenses, and we should be good to go. The patient starts off telling my staff he has some questions he wants to ask me. That’s not too unusual, so I obliged. After being in the room for 20 minutes answering a seemingly endless string of the exact same questions we discussed extensively at the last visit, I told him that we were going to hold off on doing the fit today, as I could tell he wasn’t quite comfortable with things. He immediately became agitated and disgruntled.

I call this type of patient an “askhole”—someone who asks question after question with no real desire to listen to the answer. Sometimes, just as with relationships, you’ll be partnered up with a patient whom you don’t mesh with. In cases like this, it may be more prudent to end that relationship early and encourage the patient to seek care elsewhere. That’s what I’ll be doing with this patient. In my 10 years of practice, this is the first patient I’ll be “firing” after only two visits; however, my experience tells me it’s best to end this relationship now before it causes everyone unnecessary stress.

QUOTE OF THE WEEK

“You may not think you’re going to make it. You may want to quit. But if you keep your eye on the ball, you can accomplish anything.”

—Hank Aaron