Glaukos announced that its travoprost Intraocular Implant with the iDose delivery system continued to provide sustained reduction in IOP in a 12-month interim cohort of patients in its U.S. investigational new drug (IND) phase 2 clinical trial.
Implanted during a micro-invasive procedure, the iDose Travoprost is filled with a special formulation of travoprost, a prostaglandin analog used to reduce IOP, and designed to continuously elute therapeutic levels of the medication from within the eye for extended periods of time. When depleted, the iDose Travoprost can be removed and replaced in a similar, subsequent procedure.
The 154-patient, multicenter, randomized, double-blind phase 2 trial was designed to evaluate two models of the iDose delivery system with two different travoprost elution rates, compared to topical timolol ophthalmic solution, 0.5% and with a primary efficacy endpoint of noninferiority to topical timolol. The latest phase 2 results are from an available interim cohort of 74 patients, 49 of whom have been implanted with one of the iDose Travoprost implant models, with 25 patients in the timolol comparator group. Average IOP reductions observed in this cohort of implant patients during the first 12 months shows that iDose Travoprost achieved an approximate 30% reduction in mean IOP vs. baseline IOP. In addition, the mean number of glaucoma medications ranged from 0.54 to 0.56 at 12 months in the fast and slow iDose Travoprost elution implant groups, respectively, compared to 0.72 mean medications in the timolol group. The most-recent phase 2 data also continued to reveal a favorable safety profile for iDose Travoprost, with no adverse events of hyperemia reported to date in either elution group.
Glaukos also announced that the company conducted a productive end-of-phase 2 meeting with the FDA in late 2017 and is currently making preparations to initiate a phase 3 IND clinical trial in the first half of 2018. The design of the prospective, randomized, double-blind phase 3 iDose Travoprost trial will be similar to the phase 2 trial and will enroll approximately 1,000 ocular hypertensive or open-angle glaucoma subjects at clinical sites in the United States and various international locations.
“These latest phase 2 results further underscore the potential of iDose Travoprost to provide many months of sustained glaucoma pharmaceutical therapy and tackle the significant problem of patient non-adherence to topical medication regimens,” Thomas Burns, Glaukos president and chief executive officer, said in a company news release. “We are pleased to be working cooperatively with the FDA as we prepare for the phase 3 trial, which will mark another critical step forward in the advancement of our novel and comprehensive product pipeline designed to transform glaucoma therapy.”
In addition, the company announced today that it has begun the processes to seek regulatory approvals for the iDose Travoprost in European markets and in Japan. Today’s announcement is the latest in a series of recent Glaukos pipeline milestone achievements, which also included:
- Planned initiation of U.S. investigational device exemption (IDE) pivotal clinical trial for the iStent SA Trabecular Micro-Bypass System, a standalone, two-stent procedure designed to reduce IOP in pseudophakic, mild-to-moderate open-angle glaucoma patients.
- Submission of the final clinical module of a pre-market approval application to the FDA for the iStent inject Trabecular Micro-Bypass System, a two-stent procedure designed to reduce IOP in mild-to-moderate open-angle glaucoma patients undergoing cataract surgery.
- Submission of an IDE application to the FDA, seeking authorization to study the iStent infinite Trabecular Micro-Bypass System, a standalone, three-stent procedure, in reducing IOP in refractory open-angle glaucoma patients or those with uncontrolled IOP on maximally tolerated medical therapy.