Aerie Pharmaceuticals Announces Positive Phase 2a Clinical Results for a Fixed Combination of its Rho Kinase Inhibitor, AR-12286, with Travoprost for the Treatment of Glaucoma
Combination therapy achieves significant improvement in efficacy and offers convenience of once-daily dosing
Company advancing fixed combination to Phase 2b
BEDMINSTER, N.J. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Nov 1, 2012 - Aerie Pharmaceuticals, a biotechnology company focused on the discovery and development of novel treatments for glaucoma, today announced positive top-line results from its Phase 2a study evaluating a fixed combination of the Company's Rho kinase (ROCK) inhibitor, AR-12286, with a commercially available prostaglandin, travoprost, for the treatment of glaucoma. Patients treated with the higher of two dose levels of the fixed combination product demonstrated a statistically significantly greater lowering of intraocular pressure (IOP) compared to travoprost monotherapy. Further, patients maintained their low IOP throughout the day with once-daily evening dosing of the AR-12286/travoprost combination. In addition, Aerie's investigational product was well-tolerated. There were no serious side effects reported in the study; mild to moderate and transient hyperemia (eye redness) was observed in a minority of patients and was consistent with that seen for the individual components alone. Based upon these results, Aerie is advancing the fixed dose combination to a Phase 2b study.
AR-12286 is a selective ROCK inhibitor designed to lower intraocular pressure by improving outflow of fluid via the trabecular pathway. Unlike currently available glaucoma medications, it targets the defective tissue responsible for elevated IOP. AR-12286's novel mechanism of action allows for stand-alone therapy, as well as combination therapy with commonly used glaucoma treatments.
Dr Richard L Lindstrom, Founder and attending surgeon, Minnesota Eye Consultants and Adjunct Professor Emeritus, University of Minnesota Department of Ophthalmology, commented, “Approximately half of individuals diagnosed with glaucoma receive multiple medications to control IOP. Having to administer multiple drops in the eye each day reduces patient compliance which can increase the risk of disease progression. Currently, in the U.S., there is no FDA-approved fixed combination product with prostaglandins. A once-daily product that combines a new mechanism of action with the current standard of care would offer patients a convenient treatment option that is very effective and easy to use.”
Thomas van Haarlem, M.D., President and Chief Executive Officer of Aerie Pharmaceuticals, commented, “We are very encouraged by the results of the Phase 2a study, which showed that our first fixed dose combination of AR-12286 has the potential to become a leading single drop therapy for the treatment of glaucoma. Based on these results, we are advancing the fixed combination to Phase 2b as well as continuing development of AR-12286 as monotherapy in an ongoing Phase 2/3 study.”
The seven-day, double-masked Phase 2a study enrolled 93 people in the U.S. with primary open angle glaucoma or ocular hypertension and randomized them to receive either one of two doses of Aerie's fixed combination product (0.25% or 0.5%) or travoprost. Patients were dosed once-daily in the evening and evaluated at four different time points during the day. The study was designed to evaluate the safety, tolerability and efficacy of AR-12286 in fixed combination with travoprost. Patients in the 0.5% cohort achieved a maximal reduction in mean IOP of 45% from baseline. Further, when compared to pivotal data for historical fixed dose combinations of travoprost and timolol, Aerie's AR-12286/travoprost combination achieved the lowest mean diurnal IOP.
About Aerie Pharmaceuticals
Aerie Pharmaceuticals is a privately held, clinical-stage biotechnology company dedicated to the discovery and development of novel treatments for glaucoma. Aerie's internal research and development engine has generated an innovative glaucoma pipeline. The Company's lead product candidate, AR-12286, is a highly selective Rho kinase (ROCK) inhibitor designed to lower intraocular pressure by improving outflow of fluid via the trabecular pathway with the potential of restoring normal function. Aerie currently is evaluating AR-12286 in multiple Phase 2 clinical studies as a standalone therapy and in combination with a commercially available prostaglandin. In addition, the Company is in Phase 2 clinical development for AR-13324, a novel product candidate with a dual mechanism of action that represents the first of a new proprietary class of glaucoma drugs. The Company is located in Bedminster, New Jersey and Research Triangle Park, North Carolina.
For more information on Aerie, please visit the Company's website at www.aeriepharma.com.
Contact: Aerie Pharmaceuticals
Thomas van Haarlem, 908-470-4320
President and Chief Executive Officer
Burns McClellan, Inc.
Michelle Szwarcberg, 212-213-0006
Kathy Galante, 212-213-0006
Posted: November 2012