■ Both phase 3 pivotal trials of Glaukos’ iDose TR — a novel formulation of travoprost administered during a microinvasive procedure — successfully achieved prespecified primary efficacy endpoints through 3 months, demonstrating excellent tolerability and a favorable safety profile through 12 months, according to the company. After the medication is released, the product is removed and replaced with a new iDose TR.
For each of the trials, GC-010 and GC-012, both the fast-release and slow-release iDose TR arms achieved the prespecified primary efficacy endpoint of noninferiority to the comparator arm of twice-daily topical timolol 0.5% through 3 months. In GC-010, IOP reductions from baseline during the first 3 months were 6.6 mmHg to 8.5 mmHg in the slow-release iDose TR arm vs 6.6 mmHg to 7.7 mmHg in the timolol arm. For GC-012, IOP reductions from baseline during the first 3 months were 6.7 mmHg to 8.4 mmHg in the study arm vs 6.8 mmHg to 7.2 mmHg in the control arm.