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Aerie Pharmaceuticals enters into collaboration agreement with DSM focused on technology to potentially deliver Aerie compounds to treat retinal diseases such as Wet AMD

Parsippany NJ, US, 31 Jul 2017 18:00 CEST

Aerie Pharmaceuticals, Inc. (NASDAQ:AERI), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, today announced that it has entered into a collaborative research, development and license agreement with DSM.

The research collaboration agreement includes an option to license DSM's bioerodible polymer implant technology for evaluating its application to the delivery of certain Aerie compounds, initially focused on retinal diseases. DSM's technology uses polyesteramide polymers (PEA) to produce an injectable, thin fiber that is minute in size. Preclinical experiments have demonstrated early success in conjunction with Aerie compounds, including demonstration of linear sustained elution rates over several months and achievement of target retinal drug concentrations.

Aerie previously reported data on Aerie-owned small molecule preclinical product candidate AR-13154, which inhibits Rho kinase and Protein kinase C and thus addresses vascular dysfunction, fibrosis, and inflammation. This molecule has generated lesion size decreases in a preclinical model of wet AMD (age-related macular degeneration) at levels similar to the market-leading wet AMD anti-VEGF product, and has generated meaningful incremental lesion size reduction when added adjunctively to the anti-VEGF product. Preclinical studies also demonstrated the promising potential of this molecule to reduce neovascularization in a model of proliferative diabetic retinopathy. Pending additional studies, AR-13154 and related compounds may have the potential to provide an entirely new mechanism and pathway to treat these diseases.

"A key to unlocking the potential of AR-13154 and related Aerie-owned compounds for the treatment of retinal diseases is the identification of the appropriate technology to achieve longer-term sustained delivery of our small molecules to the back of the eye. We are hopeful that DSM's PEA technology may prove to be that technology," said Vicente Anido, Jr., Ph.D., Chairman and Chief Executive Officer at Aerie.

The terms of the agreement with DSM were not disclosed and the agreement is immaterial to Aerie based on the level of current financial commitments.

About Aerie Pharmaceuticals, Inc.

Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in- class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie's two current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA (new drug application) for Rhopressa™ (netarsudil ophthalmic solution) 0.02% was submitted to the U.S. Food and Drug Administration (FDA) in February 2017, and, in May 2017, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA's review of the Rhopressa™ NDA for February 28, 2018. Aerie's second product candidate, Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa™ and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. The Roclatan™ NDA submission is expected to take place in the first half of 2018. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.