AR-13324 Found to Lower Episcleral Venous Pressure (EVP) in Preclinical In Vivo Model, Providing Further Insight into Differentiated Efficacy Profile

BEDMINSTER, NJ & RESEARCH TRIANGLE PARK, NC & NEWPORT BEACH, CA, USA I February 24, 2014 I Aerie Pharmaceuticals, Inc. (AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, today announced the results of preclinical in vivo research demonstrating the ability of AR-13324 to reduce episcleral venous pressure (EVP) in the eye. AR-13324 previously has been shown to lower intraocular pressure (IOP) by increasing fluid outflow through the trabecular pathway, the eye’s primary drain, and by reducing the production of fluid in the eye. The present study, sponsored by the Company and conducted by Jeffrey Kiel, Ph.D., and his team at the University of Texas Health Science Center, San Antonio, affirmed the hypothesis that AR-13324 also can lower IOP through a third mechanism of action, the reduction of EVP. This may represent a breakthrough in the lowering of IOP in patients with glaucoma and ocular hypertension.

According to the study results, administration of AR-13324 eye drops once daily demonstrated statistically significant reductions in EVP and IOP in an in vivo model following the third daily dose. EVP decreased by 35% relative to baseline, and IOP was reduced by 39%. Based on these results, the researchers estimated that up to 42% of the reduction in IOP caused by AR-13324 was due to the reduction in EVP. The study results will be presented at the 2014 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in May.

Casey Kopczynski, Ph.D., Aerie’s Chief Scientific Officer, commented, “These data support an additional mechanistic explanation for the activity and clinical efficacy profile of AR-13324, distinguishing this compound from currently available glaucoma drugs, which typically have been found to have no effect on EVP. As expected in a drug that lowers EVP, AR-13324 previously demonstrated consistent IOP lowering irrespective of baseline IOP in our Phase 2b clinical study, whereas the comparator agent, latanoprost, demonstrated reduced efficacy at lower baseline IOPs. AR-13324 also achieved large IOP reductions in normotensive subjects in our previous Phase 1 pharmacokinetics study. The current preclinical research adds further evidence of the differentiated profile of AR-13324.”

IOP is determined by the contributions of four distinct mechanisms of action within the eye: aqueous humor (eye fluid) production, resistance to aqueous outflow via the trabecular meshwork and uveoscleral pathways, and EVP. Historical studies have shown that EVP accounts for approximately half of IOP in normotensive subjects and approximately one-third of IOP in patients with elevated pressures of 24 – 30 mmHg. Drugs that lower IOP without lowering EVP are most effective at high IOPs, where EVP is believed to contribute less to IOP, and are less effective at lower IOPs, where EVP is seen to constitute a larger portion of IOP.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies. The Company is preparing for two Phase 3 registration trials, where the primary efficacy endpoint will be to demonstrate non-inferiority of IOP lowering for AR-13324 (dosed once daily) compared to timolol (dosed twice daily). In addition, the Company is conducting a Phase 2b clinical trial of its fixed-dose combination product PG324, where the primary efficacy endpoint will be to demonstrate superiority of PG324 to each of its components.

SOURCE: Aerie Pharmaceuticals