BLOG: Guidelines for new dry eye drugs: What DED doctors need
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As I took a break from packing for my first major meeting in 2 years, I got to thinking about all of the new dry eye disease drugs that would be on stage for the first time in NOLA.
Companies new and old are chomping at the bit to send off their newbie medicines and devices and set them free in the wild jungle that is clinical medicine. It’s not just a dry eye phenomenon, of course. Allergan has once again launched a product, Vuity (pilocarpine HCl ophthalmic solution 1.25%), that is not only new to the market but also creates an entirely new category: presbyopia-treating eye drops.* In the spirit of my advice to dry eye disease (DED) device makers, allow me to offer up some suggestions about how companies should be thinking about supporting newly and soon-to-be released medicines.
You can make an argument that the single most successful new medication launch in eye care in the last 20 years was executed by Shire and Xiidra (lifitegrast ophthalmic solution 5%, now Novartis).** The challenge with this launch was multifactorial, beginning with the fact that a large part of the prescribing population of ophthalmologists and optometrists were skeptical about whether dry eye was, in fact, a disease at all. Shire was up against an established medication, Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), that created a new class of treatment (kinda like Vuity). Making matters more challenging, Restasis had several years of patent protection remaining and would therefore be handsomely supported in the marketplace. Tough task.
What we got was arguably the fastest uptake of a new medication since Xalatan (latanoprost, now Viatris). Even with a couple of major mistakes (eg, not dissuading doctors from giving samples to Medicare patients who would then be unable to afford the uncovered medication), Xiidra grew at a breakneck pace. The key element? Intense research into the prescribing characteristics of doctors who were likely to see DED patients whose treatment would be on label, and months of preparation for a barrage of education directed toward them. Like 12 months of preparation before receiving FDA approval. If you are launching your new medicine or talking about a medicine you expect to be approved sometime in 2022 and you haven’t done this, you’ve put the commercial success of your product at risk.
How do we know this? Let’s go back to Allergan and Restasis. Allergan did not do this prior to launching Restasis way back in 2003. Without much information about what prescribing doctors faced when treating DED in the clinic, it launched a highly effective product that was very difficult to use. Only dogged determination and a refusal to quit on the medication saved Restasis from the junk heap. If there had been another effective DED drug out there at the time, I can’t imagine Restasis surviving to become the $1.4 billion behemoth it is today.
Bottom line: If you are launching a new medicine any time over the next 12 months and you don’t know who’s gonna write your scripts, what their daily challenges will be in doing so (side effects, coverage, etc) and how you will address them, you face a terribly steep uphill climb. Sale staff should have been hired as soon as your pivotal phase 3 trial succeeded. Your sample strategy should already be in place, and there should be a stockpile warehoused and ready to go. Managed market stuff should roll off the tongues of your reps with confidence; be honest about whether you can sell into the Medicare market. In general, you get 18 months after launch to gain a toehold on the treadmill to success. The race starts long before you get your FDA approval. Allergan and Shire have given you road maps to follow.
It will be fascinating to see who was paying attention.
*I continue to consult/speak for Allergan in the DED space. I do not do so for Vuity/presbyopia.
**I was involved with this project and continue to be a consultant for Novartis, which now owns Xiidra.
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