Tomas Navratil on clinical trials
From Glaukos - Tomas Navratil, Chief Development Officer · · OIS: Ophthalmology Innovation Source
“I would like to highlight the strength of the iDose infinite pivotal results based on this clinical trial that supported the 510k clearance of this first standalone administration of a mixed device.”
On , Tomas Navratil, Chief Development Officer at GLAUKOS CORP, spoke about clinical trials during Glaukos - Tomas Navratil, Chief Development Officer on OIS: Ophthalmology Innovation Source.
About Tomas Navratil
Tomas Navratil, Chief Development Officer at Glaukos, presented an update on the company’s research and development strategy at an industry event in September 2023. He discussed recent regulatory clearances and clinical trial results, including the 510(k) clearance of the iStent infinite, which he described as the first standalone administration of a trabecular bypass device. Navratil also highlighted positive Phase 3 results for the iDose TR travoprost implant, noting that in two studies involving over 1,100 patients, 93% were well controlled at 12 months after a single dose on the same or fewer topical medications, and 81% were medication-free. He characterized the safety profile as showing no serious corneal adverse events and a hyperemia rate of 3%, which he said was more than tenfold lower than that associated with topical travoprost. Navratil stated that Glaukos’s R&D strategy is based on five therapeutic platforms, which he said are capable of generating therapies for glaucoma, dry eye disease, presbyopia, keratoconus, age-related macular degeneration, diabetic macular edema, retinal vein occlusion, and other ophthalmic conditions. He noted that the company’s near-term pipeline includes the iDose TR in a pre-NDA stage and a second-generation product, iDose TREX, with twice the payload. Navratil attributed the company’s progress to support from patients and clinicians, and said Glaukos is preparing for future growth following recent approvals and positive study results.