Remember when we all thought we were going to have three or four generic competitors for Restasis? And all of the changes we would see in the marketplace for immunomodulators because there was going to be true price competition? We all girded ourselves for more step (failure first) therapy, passing through the gauntlet of ineffective or intolerable generics before being “allowed” to write for Restasis. If you thought the Anthem step therapy program to get to Xiidra (Novartis) was tough ...
Never happened. Funny, eh?
Competition, such as it is, has come from a new branded cyclosporine A (CsA), Cequa (Sun Ophthalmics). As with all things CsA, the magic is in the mix, so to speak. CsA is hydrophobic; Restasis (Allergan) gets it to the ocular surface in an oil emulsion. Cequa makes the magic happen through micelle-encapsulation that presents a hydrophilic outer surface that “camouflages” the hydrophobic active ingredient. It looks like we may actually get another branded CsA with a unique mechanism of delivery before any of those long-promised generics hit our shores. At the American Society of Cataract and Refractive Surgery 2019 meeting, John Sheppard presented the data on CyclASol 0.1% (Novaliq), CsA in a water-free solution of perfluorohexyloctane.
The details of the Sheppard study will be familiar to anyone who’s been watching the recent FDA dry eye disease studies. Both signs and symptoms were evaluated; to be approved, the FDA is now asking for one of each. CyclASol was statistically superior to the vehicle alone for both primary endpoints, total corneal staining and OSDI. The treatment effect was seen at the first study visit at 4 weeks (conjunctival staining showed a similar improvement at 4 weeks as well). Both CyclASol and vehicle were well tolerated with very few patients experiencing any significant side effects.
Is this what we need? Do we need another branded CsA in the DED market? Will a third branded CsA be the straw that breaks the PBM camel’s back? I dunno. If this was the good old days of Marshalls’ style discounts by percent-off, we would have an old-fashioned Vigamox vs. Zymar price war, but we no longer live in that place. No, I think what happens is the space stays just as fuzzy and undefined as it is now, with no real differentiation between CsA brands, with medical decisions made by fiat from afar in the star chambers at CVS, Aetna and United Health.
For now, it’s the more the merrier in the immunomodulator mosh pit.
Disclosure: White reports he is a consultant to Allergan, Shire, Sun, Kala, Ocular Science, Rendia, TearLab, Eyevance and Omeros; is a speaker for Shire, Allergan, Omeros and Sun; and has an ownership interest in Ocular Science and Eyevance.