Glaukos seeks to ‘transform glaucoma therapy’

Thomas W. Burns

Four new iStent devices are in the product pipeline, along with an intraocular drug delivery device, according to Thomas W. Burns, president and CEO of Glaukos, at the 36th Annual J.P. Morgan Healthcare Conference.

Glaukos is using an algorithm to transform glaucoma therapy with products planned to treat the full range of glaucoma, Burns said in the conference webcast.

“Glaukos now has five distinct products that we are targeting to become commercially available within the next 5 years. For a newly christened IPO company, that is an impressive font for growth. Most newly public medical device companies develop a single commercial product and quickly look for ways to profitably exit the business. We are in this to build an entirely new class within ophthalmology and, in so doing, build a formidable business,” he told Ocular Surgery News.

Patient algorithms drive products

Glaukos designs products with its patient algorithm in mind, with glaucoma separated into progressive stages, from ocular hypertension with no manifestation of glaucomatous disease, to mild and moderate open-angle glaucoma, to advanced and then refractory, representing patients who have tried all medications, exhausted their therapeutic alternatives and, in many cases, had surgeries, Burns said.

“Each of these stages of progression needs clearly defined treatment goals and desired target pressures. That’s why we’re creating a portfolio of products that can provide the best patient benefit-to-risk calculus that we can deliver at each one of these stages,” Burns elaborated to OSN.

The original iStent, indicated for use with cataract surgery to reduce IOP in adult patients with mild to moderate openangle glaucoma, was approved in 2012. Burns said each upcoming product will treat one of the stages of glaucoma. For example, the iStent inject, which could be approved by the latter part of this year, is two stents for use in conjunction with cataract surgery for the reduction of IOP in patients with mild to moderate open-angle glaucoma. Glaukos filed a premarket approval application for the product in December 2017.

The iStent SA, intended as a stand-alone procedure, would be used in pseudophakic patients with mild to moderate open-angle glaucoma. The product could be approved by 2020 or 2021, Burns said.

Glaukos finished enrollment in the pivotal phase of an FDA investigational device exemption trial for the iStent Supra in 2017, and data should be available for a PMA submission by mid to late 2019, with approval possible in 2020. Glaukos believes this product will ultimately be used as a second-line or enhancement therapy for more moderately advanced or progressive open-angle glaucoma.

Glaukos recently submitted an IDE for the iStent infinite, which is intended for use in refractory glaucoma patients, and expects approval by 2020 or 2021. For the iDose, which is designed to address a full range of glaucoma disease states, the company is targeting approval by 2022 or 2023.

“[We have created] a cascade of evolving, commercial products that will continue to give us more fulsome and deeper penetration into this large glaucoma marketplace,” Burns said.

iDose clinical data announced

Phase 2 clinical trial data for the iDose travoprost intraocular drug delivery device were reported in January, Burns said, and the system continued to provide sustained reduction of IOP in a 12-month interim cohort of patients. The iDose travoprost achieved an approximate 30% reduction in mean IOP compared with baseline IOP, according to a Glaukos press release.

Glaukos is evolving into a hybrid surgical pharmaceutical/medical device company that can drive significant shareholder value in the future, Burns said.

“We’re evolving. We’re now validating our iDose system, and we continue to pioneer and lead the MIGS market class. The narrative of our company is that we are using revenue generated in our initial beachhead MIGS combo-cataract market to fund, drive and commercialize new indications and new products in order to further penetrate this growing glaucoma marketplace and potentially advance the care of glaucoma patients worldwide,” he told OSN. – by Robert Linnehan

Disclosure: Burns reports he is the president and CEO of Glaukos.

Thomas W. Burns

Four new iStent devices are in the product pipeline, along with an intraocular drug delivery device, according to Thomas W. Burns, president and CEO of Glaukos, at the 36th Annual J.P. Morgan Healthcare Conference.

Glaukos is using an algorithm to transform glaucoma therapy with products planned to treat the full range of glaucoma, Burns said in the conference webcast.

“Glaukos now has five distinct products that we are targeting to become commercially available within the next 5 years. For a newly christened IPO company, that is an impressive font for growth. Most newly public medical device companies develop a single commercial product and quickly look for ways to profitably exit the business. We are in this to build an entirely new class within ophthalmology and, in so doing, build a formidable business,” he told Ocular Surgery News.

Patient algorithms drive products

Glaukos designs products with its patient algorithm in mind, with glaucoma separated into progressive stages, from ocular hypertension with no manifestation of glaucomatous disease, to mild and moderate open-angle glaucoma, to advanced and then refractory, representing patients who have tried all medications, exhausted their therapeutic alternatives and, in many cases, had surgeries, Burns said.

“Each of these stages of progression needs clearly defined treatment goals and desired target pressures. That’s why we’re creating a portfolio of products that can provide the best patient benefit-to-risk calculus that we can deliver at each one of these stages,” Burns elaborated to OSN.

The original iStent, indicated for use with cataract surgery to reduce IOP in adult patients with mild to moderate openangle glaucoma, was approved in 2012. Burns said each upcoming product will treat one of the stages of glaucoma. For example, the iStent inject, which could be approved by the latter part of this year, is two stents for use in conjunction with cataract surgery for the reduction of IOP in patients with mild to moderate open-angle glaucoma. Glaukos filed a premarket approval application for the product in December 2017.

The iStent SA, intended as a stand-alone procedure, would be used in pseudophakic patients with mild to moderate open-angle glaucoma. The product could be approved by 2020 or 2021, Burns said.

Glaukos finished enrollment in the pivotal phase of an FDA investigational device exemption trial for the iStent Supra in 2017, and data should be available for a PMA submission by mid to late 2019, with approval possible in 2020. Glaukos believes this product will ultimately be used as a second-line or enhancement therapy for more moderately advanced or progressive open-angle glaucoma.

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Glaukos recently submitted an IDE for the iStent infinite, which is intended for use in refractory glaucoma patients, and expects approval by 2020 or 2021. For the iDose, which is designed to address a full range of glaucoma disease states, the company is targeting approval by 2022 or 2023.

“[We have created] a cascade of evolving, commercial products that will continue to give us more fulsome and deeper penetration into this large glaucoma marketplace,” Burns said.

iDose clinical data announced

Phase 2 clinical trial data for the iDose travoprost intraocular drug delivery device were reported in January, Burns said, and the system continued to provide sustained reduction of IOP in a 12-month interim cohort of patients. The iDose travoprost achieved an approximate 30% reduction in mean IOP compared with baseline IOP, according to a Glaukos press release.

Glaukos is evolving into a hybrid surgical pharmaceutical/medical device company that can drive significant shareholder value in the future, Burns said.

“We’re evolving. We’re now validating our iDose system, and we continue to pioneer and lead the MIGS market class. The narrative of our company is that we are using revenue generated in our initial beachhead MIGS combo-cataract market to fund, drive and commercialize new indications and new products in order to further penetrate this growing glaucoma marketplace and potentially advance the care of glaucoma patients worldwide,” he told OSN. – by Robert Linnehan

Disclosure: Burns reports he is the president and CEO of Glaukos.