Aerie Pharmaceuticals will use GrayBug's microparticle-based technologies to deliver its candidates to the front and back of the eye under a just-announced one-year research collaboration and licensing agreement. In particular, Aerie ($AERI) is seeking to add sustained-release capabilities to its arsenal.
Spun out of Johns Hopkins' Wilmer Eye Institute in 2011, GrayBug's fortunes are now partially tied to Aerie's clinical trial results, which have taken investors on an emotional roller coaster of late. Aerie's shares fell 70% when its lead glaucoma eye drop disappointed in Phase III but rocketed 50% when the FDA let it change the endpoint of a second Phase III study, making approval more likely. The company hopes to submit the candidate for FDA approval in the second half of 2016.
But the three-pronged partnership will initially center on evaluating the ability of GrayBug's polymer-based delivery technology to provide multimonth release capabilities to Aerie's preclinical wet AMD candidate. The companies say the candidate (AR-13154) cut wet AMD lesion size more than Regeneron's ($REGN) market-leading Eylea.
In addition, Aerie now has the ability to test long-term sustained delivery of the active ingredient in that Phase III eye drop, dubbed Rhopressa, to the front of the eye. Aerie says it expects once-a-day dosing to improve patient compliance, leading to better outcomes. The candidate works by lowering intraocular pressure, according to the company website.
Finally, the partnership gives Aerie the exclusive option to obtain a license to use GrayBug's delivery tech to make sustained-release versions of its ophthalmic products.Aerie CEO Vicente Anido
"We are delighted to collaborate with GrayBug, and we believe their technologies will provide Aerie with the ability to make excellent progress in understanding the potential of Aerie's small molecules to provide new treatment approaches to serious diseases of the eye," said Aerie CEO Vicente Anido, Jr., in a statement. "AR-13154 has shown impressive results preclinically, and we believe the best way to provide sustained delivery of this product to the back of the eye is through GrayBug's unique delivery platform."
Aerie's third candidate is Roclatan, a single-drop fixed-dose combination of Rhopressa and Pfizer's ($PFE) Xalatan. The glaucoma-fighting med is expected to begin Phase III trials soon, according to the company's website.
GrayBug interim CEO Jeffrey Cleland said the company's drug delivery technology can result in various release profiles and achieve sustained delivery to the front and back of the eye. It achieves that feat via a biodegradable polymer microsphere/nanoparticle matrix and is also compatible with intravitreal injections, which are used to deliver drugs to the back of the eye.
GrayBug has an early-stage preclinical wet AMD candidate of its own, with plans to file an Investigational New Drug application in 2016.
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