An injectable treatment for glaucoma and other corneal disorders has been granted US Food and Drug Admiration (FDA) approval following successful Phase III trials.
California-based ophthalmic firm, Glaukos, confirmed that its iDose travoprost intracameral implant (TR) treatment indicated for the reduction of intraocular pressure in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG), has received a new drug application approved by the FDA.
The iDose TR is described as a slow-release intracameral procedural pharmaceutical therapy designed to continuously deliver a therapeutic dose of travoprost inside the eye for extended periods of time, with the aim of improving the standard or treatment in patients living with glaucoma whilst avoiding the drawbacks of traditional topical medicine.
The approval comes off the back of two prospective, randomised, multicentre, double-masked, Phase III pivotal trials launched by the company in 2018, dubbed GC-010 (NCT03519386) and GC-012 (NCT03868124). The trials were designed to compare the safety and efficacy of a single administration of iDose TR, in both a fast and slow-release form, with the aim of reducing the intraocular pressure in the eyes of patients living with open-angle glaucoma or ocular hypertension.
Both trials, randomised and involving 1,150 subjects across 89 clinical sites, were able to meet their primary efficacy endpoints across three months and were able to demonstrate tolerability and safety across 12 months. The trials were also able to see 81% of patients stop using traditional topical treatments for intraocular pressure, with 98% of patients continuing to use iDose TR after the trial’s initial year-long span.
Thomas Burns, CEO of Glaukos, said: “We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension. We are grateful to the clinical investigators and study participants in the clinical trials for their instrumental roles in helping us reach this important advancement for glaucoma patient care.
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“iDose TR has the potential to redefine the standard of care for patients in the U.S. affected by open-angle glaucoma and ocular hypertension.”
Glaukos intends to commercially launch the iDose TR in the first quarter of 2024 at a wholesale acquisition cost of $13,950, per dose.
At the same time, California-based SpyGlass Pharma has launched Phase I/II clinical trials to investigate its drug delivery platform in patients with glaucoma, assessing the safety and efficacy of the platform loaded with the drug bimatoprost during cataract surgery in patients with open-angle glaucoma or ocular hypertension.
Another Californian competitor, Sight Sciences, recently announced results for a Phase I trial testing its TearCare technology, already cleared by the FDA, treatment for dry eye disease. The study concluded it is more effective than Allergan Restasis eyedrops produced by AbbVie.