• Organizations: Glaukos
FDA scrutiny of unapproved CXL trials reveals critical lapses in patient safety and regulatory adherence
Legal

FDA scrutiny of unapproved CXL trials reveals critical lapses in patient safety and regulatory adherence

Clinicians’ failure to follow federal regulations with unapproved drugs sparks discussion on legal and ethical concerns.
Glaukos and RadiusXR partner with Topcon on VF testing platform
Products

Glaukos and RadiusXR partner with Topcon on VF testing platform

Collaboration involves the launch of RadiusXR’s new wearable vision testing platform, the first tech of its kind to combine visual fields correlated to the clinical standard.
FDA accepts NDA submission for Glaukos's Epioxa
Pipeline

FDA accepts NDA submission for Glaukos's Epioxa

Epi-on CXL iLink therapy could become the first noninvasive procedure with no need for corneal epithelium removal to treat keratoconus eyes.
Glaukos reports positive IOP-lowering clinical data on iDose platform
Pipeline

Glaukos reports positive IOP-lowering clinical data on iDose platform

Latest update includes 36-month follow-up; phase 4 results on iDose TR with cataract surgery; and a new phase 2b/3 study on a next-gen implant.
Glaukos submits Epioxa NDA for keratoconus
Pipeline

Glaukos submits Epioxa NDA for keratoconus

Next-gen corneal cross linking therapy could become the first to not require removal of the corneal epithelium.
Glaukos reports phase 3 topline data on Epioxa for keratoconus
Pipeline

Glaukos reports phase 3 topline data on Epioxa for keratoconus

Findings will support an anticipated NDA submission for the second-generation iLink therapy by the end of 2024.
Nicox and Glaukos sign global licensing option for glaucoma and retinal candidate
Business

Nicox and Glaukos sign global licensing option for glaucoma and retinal candidate

Agreement includes preclinical research for NCX 1728, the lead compound of a new class of nitric-oxide-donating molecule class.
J-Code for Glaukos' iDose TR takes effect
Products

J-Code for Glaukos' iDose TR takes effect

Permanent reimbursement code is intended to simplify and ensure consistent coverage for OAG and OHT patients across the U.S. 
Sight Sciences reports real-world data on leading MIGS devices, including OMNI Surgical System
Research

Sight Sciences reports real-world data on leading MIGS devices, including OMNI Surgical System

Large-scale, comparative study also evaluated the Hydrus Microstent and iStent inject for lowering IOP in 100,000+ glaucoma patients’ eyes.
Travoprost implant shows robust IOP-lowering in phase 3 study
Pipeline

Travoprost implant shows robust IOP-lowering in phase 3 study

Phase 3 trial finds travoprost implant as safe and effective alternative to topical IOP-lowering meds.
Glaukos' iDose TR implant assigned permanent J-code
Products

Glaukos' iDose TR implant assigned permanent J-code

Effective July 1, the micro-invasive and injectable treatment will have a permanent reimbursement.
iStent inject with cataract surgery may reduce glaucoma meds
Research

iStent inject with cataract surgery may reduce glaucoma meds

iStent Inject demonstrates clinically and statistically significant reduction in glaucoma medications at 2 years.
Glaukos' iDose TR intracameral launches in the US
Products

Glaukos' iDose TR intracameral launches in the US

MIGS sustained-release device is designed as a longer duration treatment indicated to reduce IOP in OHT and OAG patients.
 FDA approves Glaukos' iDose TR intracameral implant
Products

FDA approves Glaukos' iDose TR intracameral implant

With long-term durability, the micro-invasive and injectable treatment is indicated to reduce IOP in OHT and OAG patients.
Glaukos acquires global rights to Stuart Therapeutics' neuroprotection glaucoma asset
Pipeline

Glaukos acquires global rights to Stuart Therapeutics' neuroprotection glaucoma asset

Proprietary therapeutic has been shown to function independently of IOP control.
iDetective campaign targets early keratoconus diagnosis
Research

iDetective campaign targets early keratoconus diagnosis

Optometrist-focused initiative advocates for game-changing patient care.
Glaukos partners with Radius XR on wearable diagnostic system
Business

Glaukos partners with Radius XR on wearable diagnostic system

The portable vision diagnostic and patient engagement system is designed to detect and manage eye diseases.
Glaukos campaign targets keratoconus prevention among young adults
Events

Glaukos campaign targets keratoconus prevention among young adults

“The Rub” aims to raise awareness of keratoconus and its link to eye rubbing.
Glaukos completes enrollment of phase 3 corneal CXL trial for keratoconus
Pipeline

Glaukos completes enrollment of phase 3 corneal CXL trial for keratoconus

Secondary phase 3 pivotal trial is assessing Epioxa (Epi-on); data will support an eventual NDA submission.
FDA accepts NDA for Glaukos’s  iDose TR
Products

FDA accepts NDA for Glaukos’s iDose TR

A PDUFA target action date has been set for December 2023.