BLOG: Do we really need another cyclosporine drop?
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Timing is everything.
Joe Tauber is all excited. I mean, jump up and down, shout it from the LinkedIn rooftop excited about Novaliq’s announcement that it has submitted a new drug application for CyclASol, a new water-free formulation of cyclosporine A (CsA) for dry eye disease (DED). In truth, Joe has been really excited about this particular formulation for quite a few years, and for good reason. The phase 3 FDA trial results recently reported by Novaliq are very impressive, and if our experiences with other immunomodulators in the wild hold true, CyclASol will be extremely effective in treating the signs and symptoms of DED we commonly encounter in our clinics.
That is, if our patients can actually get their hands on it.
We have been hearing Joe and others who have been involved in Novaliq’s development programs talk about water-free CsA for years. If it had made it to the market any time in the 20-teens, it probably would have been a huge success. Imagine having Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan), Xiidra (lifitegrast ophthalmic solution 5%, Novartis) and CyclASol battling it out in the Thunderdome in, say, 2017 when the Restasis patent story was heating up. That would have been epic.
Now? Man, the headwinds confronting a new branded CsA product are just enormous. Step edits in the commercial market driving patients to generics will be a given. As much as I’d like that to be different, like CyclASol, the insurance carriers are highly unlikely to see it that way. Every dry eye drug manufacturer is going to face increasing pressure to lower the effective cost of their drugs for the patient. Congress has gotten off the schneid and is making an effort to force companies to do this. Can you recoup the years-long investment in a truly new product in this environment? Can you charge enough to make a profit?
Whether you are a smaller developmental company like Novaliq or a large strategic looking to fill the holes in your pipeline, that is likely to be the crux of the problem. You are introducing the umpteenth CsA product into a generified market already chockablock full of immunomodulators. You still have to compete for space on formularies against entrenched foes. It’s a heavy lift.
Timing is everything.
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