Back to top

Image: Bigstock

Glaukos (GKOS) Announces PMA Submission, Boosts iStent Platform

Read MoreHide Full Article

Glaukos Corporation (GKOS - Free Report) recently submitted a supplemental pre-market approval (PMA) application to the FDA with respect to its iStent infinite Trabecular Micro-Bypass System. It is worth mentioning that the iStent infinite is similar to the company’s two-stent iStent inject W Trabecular Micro-Bypass System that has received the FDA approval for lowering intraocular pressure (IOP) in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery.

The iStent infinite is an investigational device developed for utilization in a standalone procedure to lower elevated IOP in patients having open-angle glaucoma, which could not be controlled by previous surgical or medical therapy.

This submission is likely to provide a boost to Glaukos’ iStent platform.

More on the News

Per management, this filing represents an important achievement for Glaukos as it is in line with the company’s commitment toward its broad pipeline of novel glaucoma surgical devices and continued pharmaceuticals.

Zacks Investment Research
Image Source: Zacks Investment Research

On the back of solid pivotal data indicating favorable safety and effectiveness, management is optimistic about iStent infinite being beneficial for ophthalmic surgeons as it brings a compelling new treatment. This treatment is an alternative in a standalone procedure for patients with open-angle glaucoma that could not be controlled by previous surgical or medical therapy.

Market Prospects

Per a report by Verified Market Research, the glaucoma treatment market was worth 7.90 billion in 2020 and is estimated to reach $13.54 billion by 2028, witnessing a CAGR of 6.9% during the forecast period (2021-2028). Increasing cases of glaucoma worldwide, and innovation in technology and new drug developments are anticipated to fuel this market’s growth. Hence, this submission is well-timed for Glaukos.

Recent Developments

In June, the company announced the completion of patient enrollment and randomization in its FDA New Drug Application (NDA) Phase 3 clinical trials for the iDose TR sustained-release travoprost implant.

In the same month, Glaukos announced that the Therapeutic Goods Administration (TGA) of Australia has granted regulatory approval for the PRESERFLO MicroShunt. The PRESERFLO MicroShunt is intended for the reduction of intraocular pressure (IOP) in eyes of patients with primary open-angle glaucoma where IOP remains uncontrollable while on maximum tolerated medical therapy and/or where glaucoma progression warrants surgery.

Price Performance

Shares of the Zacks Rank #3 (Hold) company have gained 19.7% in a year’s time, compared with the industry’s rally of 19.5%.

Key Picks

Some better-ranked stocks from the broader medical space are Henry Schein, Inc. (HSIC - Free Report) , Envista Holdings Corporation (NVST - Free Report) and Merit Medical Systems, Inc. (MMSI - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

Henry Schein’s long-term earnings growth rate is estimated at 13.9%.

Envista Holdings’ long-term earnings growth rate is estimated at 27.4%.

Merit Medical’s long-term earnings growth rate is projected at 13.6%.