Glaukos, an ophthalmic medical technology company, has signed a licensing agreement with Intratus, for a drug delivery platform designed to treat dry eye disease, glaucoma and other corneal disorders.
Under the agreement, Glaukos obtains an exclusive license to research, develop, manufacture and commercialize Intratus’ patented, non-invasive drug delivery platform.
Intratus’ cream-based drug formulations are applied to the outer surface of the eyelid for transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders.
Intratus co-founder and chief executive officer Aaron Dyer said: “Intratus’ drug delivery platforms aim to provide an efficacious, safe and durable treatment option for ophthalmic diseases through a simple, non-invasive and patient-friendly method of application.
“We believe Glaukos’ proven track record in pioneering new treatment paradigms makes them the perfect partner to help bring our novel treatment options, if approved, to patients and physicians in the most effective and timely manner possible.”
Glaukos said that the early human studies using the advanced delivery system, with drugs delivered as topical eye drops have showed that the platform works effectively without side effects.
Financial terms of the agreement were not disclosed.
In April 2019, Glaukos signed a collaboration and distribution agreement with Santen Pharmaceutical’s US subsidiary for exclusive distribution of MicroShunt (DE-128) in the US market.
Under the agreement, Glaukos is given exclusive rights to supply MicroShunt, which is a novel, minimally-invasive and ab-externo surgical device, designed for primary open-angle glaucoma (POAG).
Glaukos said that the device is being evaluated in a pivotal trial of the US Food and Drug Administration (FDA) for intraocular pressure (IOP) reduction in patients with POAG where intraocular pressure is uncontrolled with maximum tolerated medical therapy or where the progression of the disease warrants surgery.
Santen is expected to pursue US FDA PMA following the completion of the premarket approval (PMA) submission anticipated this year, and to launch the products in the US in 2020, if approved.
MicroShunt is manufactured using biocompatible material called SIBS, and marks the first glaucoma device to be compared with trabeculectomy in a randomized, masked, multicentre study.
The device is commercialized in Europe as InnFocus MicroShunt under CE mark, and is currently under the process of rebranding under the new global commercial name of Preserflo MicroShunt.