Glaucoma Treatment Shows Positive Results in Phase 3 Trial
Researchers will submit a new drug application to the FDA after a phase 3 trial found that iDose TR slow- and fast-release models met their primary endpoint in patients with glaucoma.
Glaukos Corporation announced that the phase 3 iDose TR pivotal trials met their primary efficacy endpoint, as iDose TR was not found to be inferior to topical timolol 0.5% BID topical timolol ophthalmic solution. iDose TR had a favorable 12-month safety profile and up to 98% of patients treated with iDose TR had excellent tolerability.
“We are very pleased to announce these robust and replicative positive phase 3 pivotal data results for iDose TR, which mark a major milestone for our company and powerfully reaffirms our view that iDose TR can be a transformative novel technology able to fundamentally improve the glaucoma treatment paradigm for patients,” said Thomas Burns, Glaukos chairman and chief executive officer, in a press release.
The novel formulation of iDose TR contains travopost, which can reduce intraocular pressure (IOP). iDose TR is offered as an alternate solution to daily eye drops.
The iDose TR phase 3 programs consisted of 2 prospective, randomized, double-masked pivotal clinical trials. It was designed to compare the safety and efficacy of iDose TR treatment with twice-daily 0.5% BID. iDose TR contains 2 treatment options—fast-release and slow-release—and the treatment aims to reduce elevated IOP in patients suffering from ocular hypertension, or open-angle glaucoma (OAG).
Both trials enrolled 1150 participants across 89 clinical sites for 3 months. Trial 1, called GC-010, randomized 590 patients. Among the participants, 200 received slow-release iDose TR, 197 received fast-release iDose TR, and 193 patients took the comparative 0.5% BID.
In the second trial called GC-012, 183 participants were administered slow-release iDose TR,185 were administered fast-release iDose TR, and 193 patients took the timolol solution.
Over 3 months, the research team found that neither the fast- nor slow-release iDose TR arms were inferior to twice-daily 0.5% BID. In the first GC-010 trial, the slow-release iDose TR reduced IOP by 6.6-8.5 mmHG. The control treatment only decreased IOP by 6.6-7.7 mmHG.
In the GC-012 trial, the slow-release iDose TR reduced IOP from baseline to 3 months by 6.7-8.4 mmHG, compared to 6.8-7.2 mmHg in the timolol treatment.
In both phase 3 trials, 81% of participants who took the slow-release iDose TR were free of other IOP-lowering topical medications at 12 months. There were no severe adverse events, such as corneal endothelial cell loss or periorbital fat atrophy, in the iDose TR.
“We believe there is an important unmet clinical need and strong appetite within the ophthalmic community for safe, effective and sustained dropless pharmaceutical alternatives to traditional topical medications. These data leave us ideally positioned for an upcoming NDA submission and FDA review for iDose TR as we continue to advance our mission to transform vision for the benefit of patients around the globe suffering from chronic eye diseases,” Burns said in the press release.
Glaukos Corporation. Glaukos Announces Positive Topline Outcomes for Both Phase 3 Pivotal Trials of iDose TR, Achieving Primary Efficacy Endpoints and Demonstrating Favorable Tolerability and Safety Profiles. Business Wire. September 7, 2022. Accessed on September 8, 2022. https://www.businesswire.com/news/home/20220907005394/en