FDA approve generic version of Restasis

FDA approve generic version of Restasis


Darrell E. White, MD

Amneal has entered the immunomodulator market. 

Where once this was a cauldron of complexity the modern market now pivots around two questions: Does your widget work as well as Restasis (cyclosporine ophthalmic emulsion 0.05%, AbbVie)? What is the direct cost to the patient? There are four branded immunomodulators — Restasis, Xiidra (lifitegrast ophthalmic solution 5%, Bausch + Lomb), Cequa (cyclosporine ophthalmic solution 0.09%, Sun Pharmaceutical), and Vevye (0.1% cyclosporine ophthalmic solution, Harrow) — and two generics (AbbVie and Viatris).

The effectiveness of cyclosporine is determined by the vehicle, regardless of concentration. Xiidra just works. If you wait long enough Restasis (and AbbVie generics), Cequa, and Vevye all have vehicles that effectively deliver enough cyclosporine A to the ocular surface to decrease dry eye signs and symptoms. In our experience the vehicle in the Viatris generic underperforms Restasis in the field; we regularly switch patients to another immunomodulator.

Nobody cares about list price. If you want to play in this space, and if your drug is at least as good as Restasis, the monthly out of pocket better be less than $100 and be easy to prescribe. One click in my E-Rx. Your competition isn’t in the managed market cage fight, it’s Mark Cuban CostPlusDrugs.

And I have my BFF on speed dial.

Darrell E. White, MD

  • SkyVision Centers, Westlake, Ohio


Disclosures: White reports no relevant financial disclosures.



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