Glaukos beats path to FDA after eye implant trials hit goals

Glaukos has reported wins in a pair of late-phase clinical trials, teeing it up to seek FDA approval of its travoprost intraocular implant next year. The studies found the implant was noninferior to the active control, twice-daily topical timolol ophthalmic solution, in glaucoma and ocular hypertension patients. 

California-based Glaukos is built on the idea that the nonadherence associated with eye drops can make the incumbent drug delivery format ineffective. To address the problem, the company has developed a biocompatible titanium implant, iDose TR, that releases a proprietary formulation of travoprost inside the anterior chamber. As an implant, iDose TR tackles the adherence issues associated with eye drops. 

The outstanding question was whether the implant could achieve comparable ocular outcomes to eye drops. To answer that question, Glaukos ran a pair of phase 3 trials that randomized patients with open angle glaucoma or ocular hypertension to receive one of two forms of iDose TR or a control therapy. The participants in the control arm underwent a sham surgery and received active eye drops, while people in the iDose TR arm received the drug-eluting implant and then took placebo eye drops. 

Across the first three months of the GC-010 trial, intraocular pressure reductions in the slow-release iDose TR arm ranged from 6.6 to 8.5 mmHg, compared to a 6.6- to 7.7-mmHg range in the timolol control arm. The ranges for the second trial, which was nearly identical to GC-010, were 6.7 to 8.4 mmHg in the slow-release iDose TR arm and 6.8 to 7.2 mmHg in the timolol control cohort.

The results caused the studies to meet their primary noninferiority endpoints. By other measures, iDose TR beat the control. Most, 93%, of slow-release iDose TR subjects remained well controlled on the same or fewer pressure-lowering topical medications at 12 months compared to screening, versus 67% of timolol control subjects in both phase 3 trials. 

Glaukos is now beating a path to the FDA. The company plans to seek approval for the slow-release iDose TR candidate and receive a decision from the FDA by the end of next year. Shares in Glaukos climbed around 17%, rising toward $60 a pop, in the wake of the data drop.