THE PHARMACOLOGY OF AGN 192024 (LUMIGAN), A NOVEL OCULAR HYPOTENSIVE AGENT.

Achim H.-P. Krauss, June Chen, David F. Woodward

Department of Biological Sciences, Allergan, Inc., Irvine, CA, USA

Purpose: AGN 192024 (Lumigan) is a novel, potent, and long-acting ocular hypotensive agent.  In order to elucidate the pharmacology of AGN 192024, an extensive series of in vitro studies was performed.

Methods: The in vitro methods involved functional and radioligand binding studies on recombinant and natural receptors. IOP was determined by pneumatonometry in dogs (5 days, qd) and in laser-induced ocular hypertensive monkeys (single drop).

Results and Discussion: AGN 192024 exhibited no meaningful pharmacological activity (IC50/EC50 > 10 microM) at a panel of greater than 100 drug targets.  These included receptors that are known anti-glaucoma drug targets as follows: adenosine (A1-3), adrenergic (alpha-1, alpha-2, beta-1, beta-2), cannabinoid (CB1, CB2), dopamine (D1-5), muscarinic (M1-5), prostanoid (DP, EP1-4, FP, IP, TP). AGN 192024 exhibited activity only in a prostamide-sensitive preparation, namely the feline iris-sphincter. Thus, AGN 192024 appears to mimic the activity of recently discovered endogenous substances called prostamides which are naturally occurring in the eye. AGN 192024 was a potent and efficacious ocular hypotensive agent in Beagle dogs and cynomolgus monkeys; at a 0.03% concentration, the maximal IOP decreases were 37% and 35%, respectively. It was long-acting and a single dose produced substantial decreases in IOP at 24 hours post-administration.