Glaukos’s iDose, as seen implanted in the eye

Glaukos has announced positive clinical updates for its iDose sustained release procedural pharmaceutical platform.

The tech company’s 36-month follow-up analysis of its two phase 3 iDoseTR (travoprost intracameral implant) 75μg showed sustained substantial intraocular pressure (IOP) reductions in approximately 70% of treated subjects versus 58% of timolol control subjects.

It said iDose TR also demonstrated excellent tolerability and a favourable safety profile at 36 months. The titanium minimally invasive glaucoma surgery (MIGS) device contains a preservative-free proprietary formulation of travoprost and is designed for a single administration for patients with open-angle glaucoma or ocular hypertension.

Glaukos also said it has commenced a phase 2b/3 clinical programme for iDose TREX, which is designed to be similar to the original iDose TR but has nearly twice the drug capacity.

In related news, the company announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for Epioxa – a corneal crosslinking iLink therapy for the treatment of keratoconus. If approved, it will be the first such non-invasive therapy to not require removal of the corneal epithelium.

The submission includes data from two phase 3 pivotal trials of Epioxa, which both achieved their primary efficacy endpoints and demonstrated favourable tolerability and safety profiles.

Epioxa is designed to reduce procedure times, improve patient comfort and shorten recovery time, said Thomas Burns, Glaukos chair and CEO. “This represents a potentially meaningful advancement in the treatment paradigm for patients suffering from keratoconus,” he said.