APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension) for the Treatment of Inflammation and Pain after Cataract Surgery

Jeffrey Levenson¹, Thomas Walters², Joseph Martel³, Laurene Wang⁴, Derek Nunez⁴

¹Levenson Eye Associates; ²Keystone Research; ³Martel Eye Medical Group; ⁴AimMax Therapeutics, Inc.

ARVO Session: Anti-inflammatory agents, antibiotics, and antivirals
Presenter:  Jeffrey Levenson, M.D.

Date:  May 2, 2022

APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension) is an ophthalmic nanosuspension that is prepared by dispersing nanomilled clobetasol propionate, a corticosteroid, with a mixture of excipients in a multi-dose preserved aqueous formulation. The proprietary nanomilling technology allows clobetasol propionate to be formulated as an aqueous suspension. This suspension of clobetasol propionate nanoparticles in APP13007 is designed to enable efficient penetration of clobetasol propionate into the eye upon ocular surface instillation and deliver therapeutically relevant concentrations of clobetasol propionate to the target tissues within the eye. APP13007 is being developed for the treatment of postoperative inflammation and pain following ocular surgery.

Clobetasol propionate is a corticosteroid with a potent activity at the glucocorticoid receptor and only slight degree of mineralocorticoid activity. It has very potent anti-inflammatory properties and it is classified as a Class 1 – Superpotent corticosteroid in the United States.

Clobetasol propionate formulations have been approved and used for over 30 years to treat the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses such as psoriasis, eczema and atopic dermatitis. However, clobetasol propionate has not been formulated for use in ophthalmic products, and therefore there is no previous human experience with ocular instillation of clobetasol propionate.

Download this Poster to Discover:

• Efficacy in clinical study of  different dosing regimen.
• Anti-inflammatory and pain reduction ability compared with placebo in post-cataract surgery recovery.
• Safety profile and IOP risks for  this novel ophthalmic nanosuspension.

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