How generic cyclosporine might affect optometry

The views expressed here belong to the author. They do not necessarily represent the views of Optometry Times or UBM Medica.

Recent court rulings are paving the way for generic cyclosporine (Allergan), more sooner than later.¹ Whether it comes to fruition remains to be seen.

My initial reaction to this development was positive because I thought such a move would lead to lower drug prices.

However, manufacture of generic cyclosporine won’t come without a cost. 

Previously from Dr. Hom: Using neurostimulation to treat dry eye

The cost of generics

I foresee every dry eye script I write to be “changed” to generic cyclosporine. This means optometrists will be straddled with more already burdensome prior authorizations and delays for the patients.

And speaking of delays, what about the efficacy of a generic cyclosporine? We have already seen what generic formulations have done to steroids like Pred Forte (prednisolone, various manufacturers) and glaucoma meds like Xalatan (latanaprost, Pfizer). There has been poor efficacy with generic Pred Forte because of poor quality uniformity in the suspension particles.² Studies have shown poorer pressure control with generic Xalatan.^3,45

Restasis has a complicated manufacturing process, involving the highly efficient emulsion vehicle.^6,7 You know this vehicle-Refresh Optive Advanced. This vehicle took years to develop, so it’s positive that it stands as itself as a dry eye treatment.

So, with generic cyclosporine, optometrists and patients will be at the mercy of a generic formulation with the only requirement inclusion of the active ingredient. Will excipients and vehicles be formulated at the generic manufacturer’s pleasure with a focus on cost?

We know Restasis takes time to work.⁸ In my opinion, a good part of the efficacy is due to the emulsion vehicle. Emulsions stay on the eye longer, increasing bioavailability of the drug, in this case cyclosporine.⁹

Related: Reduce dropout in patients with dry eye

Substituting a different vehicle in a generic formulation will likely worsen efficacy.

Restasis takes time to work. Would generic cyclosporine take years to work?

References

1. Thomas K. Patents for Restasis Are Invalidated, Opening Door to Generics. NY Times. Available at: https://www.nytimes.com/2017/10/16/health/allergan-restasis-patent-.html. Accessed 11/2/17.

2. Roberts CW, Nelson PL. Comparative analysis of prednisolone acetate suspensions. J Ocul Pharmacol Ther. 2007 Apr;23(2):182-7.

3. Golan S, Rosenfeld E, Shemesh G, Kurtz S. Original and generic latanoprost for the treatment of glaucoma and ocular hypertension: are they really the same? Clin Exp Pharmacol Physiol. 2015 Feb;42(2):220-4.

4. Kahook MY, Fechtner RD, Katz LJ, Noecker RJ, Ammar DA. A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography-tandem mass spectrometry. Curr Eye Res. 2012 Feb;37(2):101-8.

5. Wadhwani M, Mishra SK, Angmo D, Velpandian T, Sihota R, Kotnala A, Bhartiya S, Dada T. Evaluation of Physical Properties of Generic and Branded Travoprost Formulations. J Curr Glaucoma Pract. 2016 May-Aug;10(2):49-55.

6. Ames P, Galor A. Cyclosporine ophthalmic emulsions for the treatment of dry eye: a review of the clinical evidence. Clin Investig (Lond). 2015;5(3):267-285.

7. Sarker DK. Manufacture. Pharmaceutical Emulsions: A Drug Developer's Toolbag. Chichester, UK: John Wiley & Sons, Ltd, 2003. doi: 10.1002/9781118648384.ch4

8. Williamson JF, Huynh K, Weaver MA, Davis RM. Perceptions of dry eye disease management in current clinical practice. Eye Contact Lens. 2014 Mar;40(2):111-5.

9. Mitra AK, editor. Ophthalmic drug delivery systems. Informa Health Care; 2003 Mar 25.

Read more from Dr. Hom here