Learning about Tyrvaya: Education in the wild
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Dry eye disease doctor friend: “What’s your take on the new dry eye spray?”
Me: “None.”
Doc: “What do you mean? You always know everything first.”
Me: “No one has talked to me about it.”
Doc: “...”
Me: “True story.”
It has been a long time since a new medication or device in which I had an interest made it to the market and I knew so little when it made landfall. Perhaps since the days of the fluoroquinolone wars of the aughts when it seemed like a new variant, er, variety came onto the market on a monthly basis. I mean, when I was the first patient to put a drop of Restasis (cyclosporine ophthalmic emulsion 0.05%) in my eye in Cleveland, I met the Allergan representative in the parking lot and told them how cool their medication was. I courted the Eyeonics rep so aggressively, trying to get on the early adopter list, that they openly wondered if I was a stalker.*
In all seriousness, it is pretty rare for me to not be “in the know” about a new product in the dry eye disease (DED) space. For whatever reason, when Tyrvaya (varenicline solution 0.03 mg, Oyster Point Pharma) was approved and hit the market, I had minimal knowledge about it as a product. The mechanism of action is similar to the late, much lamented TrueTear (Allergan): activate the fibers of the trigeminal nerve in the nose in order to induce tear production. Beyond that, I was the proverbial blank slate.
So, I thought I would make good on the promise that I make to every new rep who visits us at SkyVision: tell us whatever it is that we need to know about your product, but only tell us once. We will give you as much time as you need to do so, whether that is 5 minutes or 55 minutes. As it turns out, we had been introduced to our Oyster Point rep weeks before approval. Let us call her “Emilie.”** An experienced pharma rep, she is new to eye care. On her first visit, she was accompanied by her regional manager, an Inspire vet who was returning to our world after a sojourn elsewhere in the body. We will call him “Scott.”** We invited them to “detail” the doctors and staff at our office on all things Tyrvaya.
Here is our experience and what we learned.
We had offered to provide Emilie an “intro to dry eye” experience to help get her eye care career off on the right foot, so everyone already knew her. Emilie and Scott asked for an hour so that they could spend some time with each tech and doctor. As an aside, our group has a rather eclectic collective diet (vegetarian, pescatarian, keto, no cheese), but the Oyster Point team nailed lunch.*** Three of the four docs in our group were there, as were all of the techs and coordinators; the front desk staff came in shifts.
Scott and Emilie came armed with enough printed information on Tyrvaya that each person had their own copy. While this may sound trivial, it actually led to quicker absorption of the information by everyone and generated faster, better questions. Likewise, they brought enough samples so that each of us had our own when it was time to try the spray. Think about that for a minute. You can easily share a bottle of eye drops. Even in non-COVID times, who wants to share a nasal spray sample with someone else? Ew! Subsequent to this meeting, I learned that these tiny details were Emilie’s and Scott’s ideas. Memo to Oyster Point No. 1: Make these standard operating procedures.
Before you use the spray, the bottle needs to be primed. Seven pumps and you are good to go. Think you know how to properly administer a nasal spray? Probably not! Most people shove the tip of their nasal spray as far up their nose as possible. Think of the “sweet spot” for TrueTear and then push further! Tyrvaya, and likely all nasal sprays, is actually designed to be delivered just below the inferior meatus, about 0.5 inch in, with the tip angled toward the ear on the same side as the nostril you spray. Perfect form would include pushing your tongue against the roof of your mouth to slow down flow in the back of your throat.
Tyrvaya is a nicotinic activator of muscarinic receptors. When it is properly applied in the nose, it activates the trigeminal nerve, which in turn sends signals to all three elements of the lacrimal functional unit (lacrimal gland, goblet cells, meibomian glands). This leads to a nearly instantaneous increase in basal tear production. All of us experienced this. And then you sneeze! Oh yeah, you really do. In the pivotal phase 3 trial, 82% of subjects sneezed. We batted 1.000 — every SkyVision staff member sneezed. This is a side effect you gotta, musta, hafta tell every patient about. We had a bit of burning in the nose and back of the throat, but that was pretty much it for side effects in our group.
The “sig” is one spritz in each nostril twice daily. A prescription is for two bottles, enough Tyrvaya to produce 45 days of treatment, give or take. If there is a “pause” in treatment for more than 2 days, the bottle needs to be primed again. There are no special storage requirements for either samples in the office or at home. As expected, Oyster Point has a generous program to help patients with commercial insurance get the first year of treatment at a low cost (ask your Emilie for details). Also as expected, there is no coverage for Medicare patients. Emilie and Scott received no instruction from the company on how to deal with this so memo No. 2: Do not prescribe for Medicare patients. You force doctors and staff to discuss how much it costs and how Medicare does not cover it.
Other than that, for whom should you prescribe Tyrvaya? Frankly, I have no idea. While the “science” side of the Tyrvaya team headed up by Dr. Marian Macsai aggressively sought input from an all-star team of DED doctors before approval, I can find no evidence of a similar effort on the commercial side. No guidance on who the optimal patients might be had been provided. Is Tyrvaya an alternative to artificial tears in a patient with early-stage DED? Should we wait for clearance of surface inflammation as we often do before using punctal plugs in aqueous-deficient DED? Can we use Tyrvaya as an alternative to immunomodulators, and if so, is there a symptom/sign combination in which that makes best sense?
These are the kinds of questions I get asked whenever a new drug hits the streets, the kinds of questions that the commercial side of the industry typically vets before approval so that frontline docs like me do not have to figure it out on the fly. Memo No. 3: This is different from retina; how DED medications are used is not lifted directly from the “methods and materials” section of the phase 3 trial.
At the end of the day, it felt right for us to make good on our pledge to give reps all of the time they need to teach us something new. We give Emilie and Scott grades of A+ for the education we received, with bonus points for the forethought and initiative they showed in making their presentation. Every new medicine has a Medicare challenge when it comes to coverage; I encourage you to cut your reps and their company all the slack they need in this regard.
However, senior management on the commercial side only gets a B; when you hit the market with a new product, you need to be prepared to tell us who to treat and how this will fit into our protocols.
No worries, though. If Tyrvaya is as good out in the wild as it was in trials, DED docs in the trenches will figure it out and let you know what we discover.
*Neither one of those stories is actually true.
**These may or may not be their real first names. You know, to protect the innocent and all.
***We do not require food to be brought if we are meeting industry reps.
- For more information:
- Darrell E. White, MD, can be reached at SkyVision Centers, 2237 Crocker Road, Suite 100, Westlake, OH 44145; email: dwhite@healio.com.
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