Annual anti-inflammatory review: The most interesting market segment in eye care
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Sigh. I really thought we would have some new stuff to chat about now that it is September 2023. I mean, you know, besides Brent Saunders.
It is once again time for us to look at the state of anti-inflammatory treatment in the dry eye disease (DED) world. This category is simultaneously the cornerstone of both DED treatment and the commercial world that surrounds us and our DED patients. It has been this way since the approval of Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan) in the early aughts and for real pioneers who foresaw the dawn of treating the inflammation underlying a majority of DED with steroids since the approval of Lotemax (loteprednol etabonate ophthalmic gel 0.5%, Bausch + Lomb) in the ’90s. There has been enough interesting stuff going on in this domain since last September to devote a column once again to the anti-inflammatory landscape even though we are still pulling from the same quiver of Rx-tipped arrows.
And still waiting to see what is to come as the reproxalap story continues to unfold.
But by now, you know me. I am a dry eye geek at heart, and more than that, I find all the byzantine and Machiavellian machinations of the business side of the dry eye world to be fascinating. As a words guy, I can make “soup from stones” when necessary, and to be honest, even without a new chapter in the reproxalap saga, there were some interesting enough stones to pick up this year that our anti-inflammatory stew will still be pretty spicy.
Hmm, where should we start? How about the sample closet? It is actually a kind of crystal ball with a view of the world; you can learn a lot about what is happening in the pharma world in any specialty by opening up the closet. What do we have here? With the notable exception of branded immunomodulators, the cupboard is kind of bare. Let us start with what is there, and then we can dive into what has been going on with the rest of the stuff.
It turns out that the generification of the cyclosporine space has had almost no effect on how we start our patients on an immunomodulator. Our cabinet is filled to the brim with samples of Restasis, Cequa (cyclosporine ophthalmic solution 0.09%, Sun Pharmaceutical) and Xiidra (lifitegrast ophthalmic solution 5%, Novartis, soon to be Bausch + Lomb) but no Verkazia (cyclosporine ophthalmic emulsion 0.1%, Santen) (more on that in a little bit). Allergan, Sun and Novartis (at least for now) all have sales reps who visit our office and keep us apprised of coupon programs, cash-pay workarounds and traditional insurance. Good on all three companies for doing this. We write for whichever drug is best covered. Since three-quarters of the generic cyclosporine 0.05% is actually made by Allergan, we have a blanket policy that we do not care if our patients are put on a generic.
Until or unless we are forced to care because they actually got “Fauxstasis” and had intolerable side effects. When that happens, we switch them to Cequa and take advantage of Sun’s terrific cash-pay program. I honestly do not know if the details of these coupon/cash-pay programs are industry secrets, so I am not going to describe the details of the Sun program here. Let me just say that if you think you have a killer branded product that we should be prescribing instead of a kinda sorta comparable generic, well ... .
OK. I am back in the sample closet, this time looking for steroids. Not surprisingly, we are chockablock full of literally every version of Lotemax that Bausch + Lomb makes. You want Lotemax Gel? We got you. Lotemax SM? Bunch of boxes waiting for you. How about the topical steroids that have either “dry eye” or all of the signs of DED blepharitis on their label? Let me see. Now, where are all my samples of Flarex (fluorometholone acetate ophthalmic suspension 0.1%, Harrow) and Eysuvis (loteprednol etabonate ophthalmic suspension 0.25%, Alcon)? Each of these has an interesting backstory I have written on in the past. Flarex was compared with branded Pred Forte (prednisolone acetate ophthalmic suspension 1%, Allergan) in its pivotal phase 3 FDA study back in the ’80s, something unheard of for decades. Kala did an extraordinary job bringing to light the “phasic” nature of DED, with long periods of relative comfort interrupted by “flares”; Eysuvis is approved to treat those flares. Flarex? Eysuvis?
Bueller?
In recent years, Flarex has been sold twice, first to Santen and most recently to the compounding company formerly known as Imprimis and now going by the name Harrow. Flarex was part of a package of products including Tobradex ST (tobramycin and dexamethasone ophthalmic suspension 0.3%/0.05%), Zerviate (cetirizine ophthalmic solution 0.24%), Verkazia (cyclosporine ophthalmic emulsion 0.1%), Natacyn (natamycin ophthalmic suspension 5%) and FreshKote, none of which will be appearing on the stage in your sample closet. This is a whole new world for Harrow, dealing with branded drugs, and because of that, it should probably get a little bit of grace as it finds its way in a new world. Maybe if it goes “full Prince” and drops Harrow in favor of a “glyph,” it would get more traction, and we would get samples and write prescriptions.
It has been a year and a half since Alcon scooped up Eysuvis. Admit it — you forgot that happened, too. For a really big company with a really big footprint, Alcon has been really quiet on the pharmaceutical side of the business. No marketing. No samples. Maybe there is an online service where we can request Eysuvis, but who has time to do that? Once upon a time, you were hard-pressed to go a week without two visits from Alcon reps. I have said many times that our world is better for both doctors and patients with a healthy Alcon that is bigger rather than not. One that develops rookies like the Atlanta Braves and trades for big stars like the Yankees. It has been awfully quiet down there in Fort Worth.
Which brings us to the new reigning “Most Interesting Man in Eye Care,” the gift that keeps on giving to people like me who write about this stuff, Brent Saunders. Not gonna lie, I thought I would be writing that sentence about my new BFF Mark Cuban and his Cost Plus Drugs online pharmacy. You have to hand it to Brent; not only has he thrown the entire Bausch + Lomb pharma team behind the launch of Miebo (perfluorohexyloctane ophthalmic solution), but he also went out and picked up the only non-cyclosporine immunomodulator, Xiidra, to round out the most complete DED drug portfolio on the planet. And used someone else’s money to do so! This should keep Mr. Saunders on the “Most Interesting” throne, at least until reproxalap finds its way into our sample closets.
Or Bob Dempsey, the GOAT of “Most Interesting,” returns to the front of the eye. Come home, Bob. You know you miss us, too.
- For more information:
- Darrell E. White, MD, of SkyVision Centers in Westlake, Ohio, can be reached at dwhite@healio.com.
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