Aerie and DSM in Eye Diseases Pact
US clinical stage pharmaceutical company Aerie Pharmaceuticals has entered into a research, development and license agreement with Dutch life sciences group DSM. The agreement includes an option to license DSM’s bio-erodible polymer implant technology for evaluating its application to deliver certain Aerie compounds that are initially focused on retinal diseases.
DSM’s technology uses polyesteramide (PEA) polymers to produce a tiny injectable thin fiber. Preclinical experiments have shown early success in conjunction with Aerie compounds, including sustained elution rates over several months and the achievement of target retinal drug concentrations.
One of Aerie’s preclinical product candidates is AR-13154, which addresses vascular dysfunction, fibrosis and inflammation. The molecule has reduced the size of lesions in a preclinical model of wet AMD (age-related macular degeneration) at levels similar to the market-leading anti-VEGF (anti vascular endothelial growth factor) product. It has also generated a “meaningful” reduction in lesion size when added adjunctively to the anti-VEGF product, the company said.
Pending additional studies, AR-13154 and related compounds may have the potential to provide an entirely new mechanism and pathway to treat these diseases, Aerie believes.
“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, Aerie Pharmaceuticals’ chairman and CEO.
Aerie currently has two product candidates for treating patients with glaucoma or ocular hypertension. The Irvine, California-based company filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Rhopressa (netarsudil ophthalmic solution) in February. The FDA is set to complete its review by Feb.
An NDA submission for its second candidate, Roclatan (netarsudil/latanoprost ophthalmic solution), which is a fixed dose combination of Rhopressa and widely prescribed latanoprost, is expected to take place in the first half of 2018.