Glaukos Says FDA Oks NDA For Single Administration Per Eye Of IDose TR 75 McgDecember 14, 2023
Pharmaceutical company Glaukos Corp. (GKOS) announced Thursday the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg.
iDose TR is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).
iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.
iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
The FDA approval is based on results from two prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials (GC-010 and GC-012) designed to compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates to topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing IOP in subjects with open-angle glaucoma or ocular hypertension.
In total, the Phase 3 trials randomized 1,150 subjects across 89 clinical sites.
Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of the first quarter of 2024. Glaukos has established a wholesale acquisition cost for iDose TR of $13,950, per dose (or implant).
The company also reaffirmed its 2023 net sales range of $307 million to $310 million and introduces preliminary 2024 net sales guidance range of $350 million to $360 million.
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