Glaukos Files PMA with US FDA for iStent Inject as Glaucoma Treatment

December 29, 2017: By Jon Swedien

Glaukos has submitted a premarket approval (PMA) application to the US FDA for the iStent Inject Trabecular Micro-Bypass Stent, the San Clemente, California, company announced Dec. 27.

The iStent Inject is designed to improve aqueous humor outflow into Schlemm’s canal and reduce intraocular pressure (IOP) in mild to moderate open-angle glaucoma patients undergoing cataract surgery, Glaukos said.

It includes two heparin-coated titanium stents preloaded in an auto-injection system that allows the surgeon to inject stents into multiple trabecular meshwork locations through a single corneal entry point, the company said.

The iStent Inject met its primary effectiveness endpoint—a 20 percent or greater reduction in IOP from baseline at 24 months—in a prospective, randomized, multicenter clinical trial that included 41 sites and 505 randomized subjects, the company said. Glaukos said it plans to release efficacy and safety data from the trial in the first half of 2018.

The iStent Inject is currently approved for use in the European Union, Armenia, Australia, Brazil, Canada, Hong Kong, Singapore, and South Africa, Glaukos said.

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

China’s Innovent Plans $500 Million IPO on Hong Kong Exchange

FDA Accepts Bausch + Lomb’s NDA Filing for Loteprednol Etabonate Ophthalmic Gel

Allergan Launches Refresh Repair Lubricant Eye Drops

US Federal Trade Commission Approves Takeda’s Bid for Shire

Nikon to Acquire Ophthalmic Distributor Chuo Sangio to Merge with Optos Subsidiary

Wills Eye Hospital to Use $5 Million Gift to Support Expansion

Pixium Vision’s PRIMA Implanted in Five Patients with Atrophic Dry AMD

Iuvo BioScience Acquires Oculos Clinical Research

Alcon Will Be Worth $20 Billion to $30 Billion After Spinoff, Novartis Chairman Says

Katena Acquires Blink Medical, Adding to String of Recent Purchases

Opthea’s Phase IIb Trial for Wet AMD Candidate Reaches Midway Point for Enrollment

Ocugen Starts Phase III Trial of OCU300 for Ocular Graft Versus Host Disease

Oculocare Medical Receives US FDA 510(k) Approval for ALLEYE, an Amsler Grid App

Santen Ventures Invests $1 Million in Qura’s QSmart System

Elsalys Biotech Says New Studies Confirm Anti-CD160 Potential in Ophthalmology

Eyedaptic Presents Augmented Reality Glasses for AMD at OCTANe Summit

Quantel Medical Launches Vitra 2 Photocoagulator

Novartis Announces Plans to Spin Off Alcon

Glaukos Announces FDA Approval of iStent Inject for Lowering IOP

Aerpio Prices $45M Public Offering, Moves to Nasdaq Capital Market

Coming soon

2018 Glaucoma Device Report: A Global Market Analysis for 2017 to 2023