An injectable therapy for glaucoma and different corneal issues has been granted US Meals and Drug Admiration (FDA) approval following profitable Section III trials.
California-based ophthalmic agency, Glaukos, confirmed that its iDose travoprost intracameral implant (TR) therapy indicated for the discount of intraocular stress in sufferers with ocular hypertension (OHT) or open-angle glaucoma (OAG), has obtained a brand new drug software authorised by the FDA.
The iDose TR is described as a slow-release intracameral procedural pharmaceutical remedy designed to constantly ship a therapeutic dose of travoprost inside the attention for prolonged intervals of time, with the intention of enhancing the usual or therapy in sufferers residing with glaucoma while avoiding the drawbacks of conventional topical drugs.
The approval comes off the again of two potential, randomised, multicentre, double-masked, Section III pivotal trials launched by the corporate in 2018, dubbed GC-010 (NCT03519386) and GC-012 (NCT03868124). The trials had been designed to match the security and efficacy of a single administration of iDose TR, in each a quick and slow-release type, with the intention of lowering the intraocular stress within the eyes of sufferers residing with open-angle glaucoma or ocular hypertension.
Each trials, randomised and involving 1,150 topics throughout 89 medical websites, had been in a position to meet their main efficacy endpoints throughout three months and had been in a position to reveal tolerability and security throughout 12 months. The trials had been additionally in a position to see 81% of sufferers cease utilizing conventional topical therapies for intraocular stress, with 98% of sufferers persevering with to make use of iDose TR after the trial’s preliminary year-long span.
Thomas Burns, CEO of Glaukos, stated: “We consider iDose TR is usually a transformative, novel know-how in a position to essentially enhance the therapy paradigm for sufferers with open-angle glaucoma or ocular hypertension. We’re grateful to the medical investigators and research contributors within the medical trials for his or her instrumental roles in serving to us attain this necessary development for glaucoma affected person care.
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“iDose TR has the potential to redefine the usual of look after sufferers within the U.S. affected by open-angle glaucoma and ocular hypertension.”
Glaukos intends to commercially launch the iDose TR within the first quarter of 2024 at a wholesale acquisition value of $13,950, per dose.
On the identical time, California-based SpyGlass Pharma has launched Phase I/II clinical trials to analyze its drug supply platform in sufferers with glaucoma, assessing the security and efficacy of the platform loaded with the drug bimatoprost throughout cataract surgical procedure in sufferers with open-angle glaucoma or ocular hypertension.
One other Californian competitor, Sight Sciences, recently announced results for a Phase I trial testing its TearCare know-how, already cleared by the FDA, therapy for dry eye illness. The research concluded it’s simpler than Allergan Restasis eyedrops produced by AbbVie.