Glaukos (NYSE:GKOS) said it submitted an Investigational New Drug application to the FDA for its Travoprost intraocular implant delivered with the company’s iDose delivery system to reduce elevated intraocular pressure in patients with glaucoma.
The Travoprost intraocular implant is injected through a clear corneal incision and secured in the anterior chamber, where the iDose system provides continuously elutes therapeutic levels of medication for an extended period of time, Glaukos said.
“This IND submission represents a seminal milestone, which the Glaukos team achieved well ahead of our original 2016 timeline. We believe this micro-scale implant may be a viable answer to the ubiquitous and long-standing problem of patient non-compliance with prescription eye drops and we look forward to working cooperatively with the FDA as they review our IND submission,” CEO Thomas Burns said in a press release.
Travoprost is a prostaglandid analog that is used to reduce IOP, and Glaukos intends to conduct a randomized Phase II clinical trial to assess the safety and efficacy of 2 models of the iDose system with Travoprost, compared against topical treatment with timilol maleate ophthalmic solution.
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.
Earlier this month, Glaukos released data from a 3-year study of its iStent travecular micro-bypass stent, touting sustained reductions in intra-ocular pressure after treatment with 2 of the devices.
The study was published in the November issue of the Clinical Ophthalmology journal, the company said.
The iStent trabecular micro-bypass stent is a tiny titanium stent designed to alleviate intra-ocular pressure caused by glaucoma and indicated for use in conjunction with cataract surgery.