December 21, 2022

4 min read

Disclosures:
White reports consulting for Aldeyra, Avellino, Bausch + Lomb, Johnson & Johnson, Novartis, Orasis, Rendia, Santen, Sight Sciences, Sun, Tarsus and Trukera Medical; speaking for Novartis, Santen and Sunlight; and having ownership interest in Orasis.


Business was not supposed to be the topic of my last column of 2022.

Nope, what I planned to write about was maybe the kind of practice culture that I feel is best suited for a dry eye clinic. If I had been able to complete my interviews of the players involved sooner, it would have been awfully tempting to talk about how cool it is that the National Eye Institute just announced six related grants totaling $50 million to study eye pain associated with dry eye disease. Both of these are important topics worthy of their own column, and I promise to give them their due in upcoming months.






Darrell E. White, MD
Source: Healio Interviews

But there is nothing more interesting going on in all of eye care than the crazy mad frenzy taking place on the industry side of our little fairy world.

I mean, come on, this is just nuts! “Don’t let the door hit you in the behind on the way out” departures and fabulous, hair-on-fire grand entrances have been balanced by major companies seemingly making an “Irish goodbye” while others have kind of snuck in the side door and joined the party. Not all of this is dry eye stuff, of course, but many of the companies involved have been, or might become, dry eye companies.

The biggest deal, of course, is the resurrection of Alcon, the 800-pound gorilla of eye care. Think Jack Nicholson in The Shining peeking around the wall and sing-songing, “I’m baaaaack!” Why start with Alcon? Two reasons. First, no matter how you feel about Alcon the company, our eye care ecosystem is better for both patients and doctors if we have a healthy and vibrant Alcon in the game. Second, Alcon made the first significant moves when it bought the commercial assets of Kala and purchased Aerie. In two fell swoops (can you have more than one “fell” swoop?), Alcon entered the dry eye disease pharmaceutical arena and was back in the glaucoma game.

How about those “sneak out the back, Jack” moves by Allergan/AbbVie and Novartis I talked about in my recent blog posts? After literally years of “is you is or is you ain’t” from all of the potential manufacturers of a generic cyclosporine 0.05%, the concentration found in Restasis (Allergan), the Hamlet of the group was finally able to declare “to be.” Mylan won approval of its version of cyclosporine 0.05%, launching “Fauxstasis” this past spring and triggering “sleeper” contracts between Allergan and at least three other companies to sell so-called authorized generics made by Allergan itself. In response, Allergan/AbbVie has pulled back, still selling Restasis (and the generics, of course) but no longer marketing it or providing samples to offices.

Despite the fact that Xiidra (lifitegrast ophthalmic solution 5%) still has some legs left on its patent, it has not performed in the marketplace as Novartis had hoped. Coupled with the problematic launch of Beovu (brolucizumab), this has apparently shaken the company’s resolve. Where once eye care was recognized as one of the pillars of the Novartis business plan, a recent investor communication made no mention of eye care in the forward-going guidance regarding the company’s priorities. Novartis has been quite transparent in its goals; it plans to prioritize divisions that contain multiple drugs with billion dollar-plus in sales. At this time, none of the eye care arrows in the Novartis quiver meet those criteria.

In August, I noted that there is lots of “ dry powder ,” bundles of cash sitting in the coffers of the big “strategics” looking for something to buy. But is that really meaningful any longer? Who is really in the market for a new drug to add to their collection (think The Little Mermaid and Sebastian)? If you were Novartis and you wanted to unload Xiidra, for instance, who would buy it? Not Allergan or Sun, both of whom already have an immunomodulator of their own — Restasis and three authorized generics, and Cequa (cyclosporine ophthalmic solution 0.09%), respectively. Would Bausch + Lomb like an immunomodulator to fill out a dry eye portfolio anchored by NOV03 (perfluorohexyloctane) if it gets approved? Is Alcon still hungry enough to land a fish as big as Xiidra?

Your guess on all of that is as good as anyone’s.

All of which brings us to something truly new in eye care, the appearance of a big strategic pharmaceutical company, Viatris. Viatris was formed by the marriage of the big generic drug company Mylan and the Pfizer spin-off of Upjohn. Those with as many gray hairs as yours truly will remember Upjohn as the company that brought us Xalatan (latanoprost), the original prostaglandin analogue for glaucoma. If memory serves, Upjohn/Pfizer left the eye care space when Xalatan’s patent ran out, spawning a host of generic forms of latanoprost. Mylan is most famous in our world as the company that finally broke through all of the byzantine maneuvers by Allergan to delay the arrival of generic Restasis; it is the manufacturer of the mysterious Fauxstasis, the only nonauthorized generic 0.05% cyclosporine A on the market as I write this.

What makes Viatris so interesting and cool is it is openly saying that its ambition is to be “a leading ophthalmology franchise.” Because it already has an immunomodulator (Fauxstasis), it is unlikely to be in the Xiidra market, but it has literally been putting its money where its mouth is otherwise. In November, Viatris announced the purchase of Oyster Point, obtaining Tyrvaya (varenicline solution) and the rest of the Oyster Point pipeline. At the same time, Viatris entered into a licensing agreement with Ocuphire, giving it several products, including a dry eye pipeline. It is important to note that with the purchase of Oyster Point, Viatris has also acquired a fully developed national sales team, as well as senior management that will stay on to manage the franchise.

2022 has been quite a year for eye care. Two major companies, Allergan/AbbVie and Novartis, have sent signals that they may be stepping back a bit. Bausch + Lomb has quietly upped its dry eye game with the hoped for coming of NOV03 while continuing its excellence on the surgical side. Alcon has bought its way back into pharmaceuticals while also maintaining its position as a surgical leader. Viatris is a brand-new player that entered the arena with a big splash and big plans. Théa is quietly building its position; we eagerly await the third coming of AzaSite (azithromycin). Aldeyra? Tarsus? The two quiet elephants in the room, Johnson & Johnson and Zeiss? Fasten your seatbelts! 2023 figures to be pretty interesting, too.

Happy New Year!

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