Eyeworld

87 EW CORNEA September 2017 Contact information Mah: Mah.Francis@Scrippshealth.org de Luise: vdeluisemd@gmail.com Yeu: eyeulin@gmail.com Sheppard: jsheppard@vec2020.com noted. While oral generics are often as effective as brand name ones, this is not usually the case with topical ophthalmic corticosteroids. "A host of differences can exist between the branded version of a topical oph- thalmic steroid and its generic com- petitors," Dr. de Luise said. "These differences can have a direct bearing on efficacy, potency, and side effect profile." Prednisolone acetate 1%, considered a standard of care as a topical steroid, is a classic example where the actual formulation of the branded Pred Forte (Allergan, Dub- lin, Ireland) has historically been superior to its generic equivalent, Dr. Yeu noted. "In my experience, it was superior to its competitor versions of branded prednisolone acetate 1% because of how the active ingredient was processed," Dr. Yeu said. "The molecule size of the active ingredi- ent in Pred Forte allowed for better penetration, and thus, superior efficacy as a steroid." Concerns with generics stem from Food and Drug Administration requirements that are limited to using the same ingredients and bio- equivalence of the active ingredient. That concentration has traditionally been allowed to vary plus or minus 20%, and does not determine the vehicle, the concentration of the preservative, and the bioavailabili- ty of the preparation when placed on the ocular surface, Dr. Sheppard noted. Illustrating those concerns about inactive ingredients, called excipients, was a study of a generic form of prednisolone acetate that found it had a greater tendency for particles to agglomerate, which sub- sequently led to inconsistent dosage concentration, Dr. de Luise noted. The larger particle sizes in the gener- ic may potentially clog the tip of the medication bottle during instillation and further alter dosage consisten- cy and concentration. In contrast, the particle sizes in Pred Forte were smaller and more uniform, which allowed them to stay longer in suspension and gave a more precise dosage of the drop. 1 EW Reference 1. Roberts CW, et al. Comparative analysis of prednisolone acetate suspensions. J Ocul Pharmacol Ther. 2007;23:182–7. Editors' note: Drs. Mah and Sheppard have financial interests with Alcon (Fort Worth, Texas), Novartis, Allergan, and Bausch + Lomb (Bridgewater, New Jersey). Dr. Yeu has financial interests with Alcon. Dr. de Luise has no finan- cial interests related to his comments. EACH WEEK, OIS INTERVIEWS THE LEADERS OF OPHTHALMIC INNOVATION The conversations continue between the bi-annual OIS meetings. Subscribe for free, and listen in on weekly one-on-one candid conversations between Tom Salemi and the innovators changing the face of ophthalmology. VISIT OUR WEBSITE FOR OUR COMPLETE LINEUP OF PODCASTS WWW.OIS.NET/PODCASTS

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