Glaukos (NYSE:GKOS) said today it won a nod from the FDA for an investigational new drug Phase II study of its Travoprost intraocular implant utilizing the company’s iDose delivery system for patients with glaucoma.
The iDose system is injected through a clear corneal incision and secured in the anterior chamber to continuously elute therapeutic levels of Travoprost medication within the eye over extended periods of time, Laguna Hills, Calif.-based Glaukos said.
The product and procedure is an alternative to chronic daily prescription eye drop treatments, which can be subject to high rates of non-compliance, Glaukos said. Travoprost is a prostaglandid analog that is used to reduce intraocular pressure.
“We are very pleased that the FDA is allowing this trial to begin several months in advance of our original target date. We believe the iDose platform has the potential to address important unmet clinical needs by overcoming the significant issue of patient non-compliance with chronic prescription eye drop regimens, and reducing risk of ocular surface damage and other side effects associated with repeated applications of topical drugs,” Glaukos CEO Thomas Burns said in a press release.
The Phase II trial follows Glaukos recent IND submission proposal for a randomized trial to assess the safety and efficacy of 2 different models of the iDose system with different travopost elution rates, compared against topical timolol maleate ophthalmic solution, the company said.
The IND application from the company included information on the drug’s history of safety and efficacy, as well as data from a 69-patient preclinical program of the drug which reported mean IOP lower in the treatment group than the topical medication group.
