FDA Approves Glaukos' Eye Implant To Treat Eye Pressure In Glaucoma Patients

The FDA approved Glaukos Corporation's GKOS marketing application for a single administration per eye of iDose TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

iDose TR is a 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. 

The FDA approval is based on results from two 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 (referred to as the fast- and slow-release iDose TR models, respectively) to topical timolol ophthalmic solution, 0.5% BID (twice a day).

The Phase 3 trials randomized 1,150 subjects across 89 clinical sites.

Phase 3 trials achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. 

IOP reductions from baseline over the first 3 months were 6.6-8.4 mmHg in the iDose TR arm, versus 6.5-7.7 mmHg in the timolol control arm.

At 12 months, 81% of iDose TR subjects were free of IOP-lowering topical medications across both trials.

Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of Q1 of 2024. Glaukos has established a wholesale acquisition cost for iDose TR of $13,950 per dose (or implant).

The company reaffirms its 2023 net sales range of $307 million to $310 million versus the consensus of $309.09 million. It introduces a preliminary 2024 net sales guidance range of $350 million to $360 million compared to the consensus of $348.64 million.

Price Action: GKOS shares are up 7.58% at $65.00 during the premarket session on the last check Thursday.

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