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Glaukos Receives Permanent J-code for iDose® TR (travoprost intracameral implant)

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Glaukos (NYSE: GKOS) receives a new J-code, J7355, effective July 1, 2024, for iDose TR, a prostaglandin analog for reducing intraocular pressure. The code aims to enhance patient access in the U.S. and streamline billing processes. CMS also assigns CPT codes 0660T and 0661T for iDose TR.
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The assignment of a unique permanent J-code, J7355, for iDose TR by CMS is a significant development in the healthcare reimbursement landscape. This procedural code simplifies the billing process for healthcare providers and ensures that patients have improved access to this glaucoma treatment. From a policy standpoint, this move by CMS reflects an acknowledgment of the therapy's potential benefits and its acceptance into standard treatment protocols.

For stakeholders, specifically investors and Glaukos Corporation, the new J-code could lead to increased usage of iDose TR, as insurers are more likely to cover treatments with an assigned J-code. This can potentially drive up sales and market share for Glaukos, positively impacting its financial outlook. However, it's essential to monitor how the adoption of iDose TR progresses post-July 1, 2024, when the code becomes effective, to understand the actual impact on the company's revenue.

iDose TR's innovation lies in its ability to provide a long-duration, therapeutic level of travoprost for glaucoma patients, which could be a game-changer in terms of compliance and side effect management. The J-code could encourage more ophthalmologists to recommend iDose TR, knowing that the reimbursement process will be more straightforward. This can lead to a shift in treatment patterns within the field of ophthalmology, potentially improving patient outcomes.

However, the long-term success of iDose TR will depend on its clinical efficacy and safety profile compared to existing treatments. Should iDose TR demonstrate superior or equivalent outcomes with fewer side effects, it would likely become a preferred option for both clinicians and patients, further solidifying its market position.

The allocation of J-code J7355 to iDose TR is an indicator of the product's market readiness and potential for adoption. By analyzing the size of the glaucoma treatment market and the prevalence of ocular hypertension and open-angle glaucoma, one can infer that the addressable market for iDose TR is substantial. The streamlined billing facilitated by the J-code could lead to a competitive advantage for Glaukos, as ease of reimbursement is a critical factor in product adoption.

It's important to track how competitors in the space respond to this development, as they may seek similar coding approvals or adjust their strategies accordingly. The impact on Glaukos' stock will likely depend on the uptake of iDose TR post-J-code implementation and the overall market dynamics, including competitor actions and payer acceptance.

New J-code for iDose TR®, J7355, set to become effective July 1, 2024

ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for iDose® TR (travoprost intracameral implant) 75 mcg, a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) or open-angle glaucoma (OAG).

The new J-code for iDose TR, J7355, is set to become effective July 1, 2024. It is expected to increase patient access in the U.S. and has been published here on the CMS website.

“The receipt of a product-specific J-code for iDose TR supports our market access initiatives to enable broad access and coverage for patients suffering from open-angle glaucoma or ocular hypertension,” said Thomas Burns, Glaukos chairman and chief executive officer. “This new J-code, once effective, should provide more streamlined, consistent, and dependable coverage and payment for iDose TR as we advance and ultimately accelerate our initial commercial launch activities.”

J-codes are used by U.S. government and commercial payers, as well as surgeons, to streamline the billing and reimbursement process for procedural pharmaceuticals administered by a healthcare professional, such as iDose TR, along with other certain treatments.

In addition to the J-code, on March 21, 2024, CMS issued its April 2024 Update of the Hospital Outpatient Prospective Payment System (OPPS) transmittal published here on the CMS website, in which it assigned the CPT codes that are designed to be used to cover the procedural component of iDose TR, 0660T and 0661T, to ambulatory payment classification (APC) 5492 (Level 2 Intraocular Procedures), effective April 1, 2024.

iDose TR is a first-of-its-kind, long-duration, intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and continues to develop a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

About iDose® TR (U.S.)

iDose TR (travoprost intracameral implant) is a long duration prostaglandin analog approved for a single administration and indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Made from medical-grade titanium, iDose TR is implanted through the trabecular meshwork and back wall of Schlemm's canal, directly into scleral tissue. Once implanted, 75 mcg of a novel, preservative-free, proprietary formulation of travoprost continuously elutes into the anterior chamber via membrane-controlled diffusion, allowing for 24/7 release of medication.

Indication for Use: iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Dosage and Administration: For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.

Contraindications: iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.

Warnings and Precautions: iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.

Adverse Reactions: In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.

Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the extent to which the issuance of the J-code for iDose TR will provide more streamlined, consistent, and dependable coverage and payment for iDose TR, the timing and extent to which we obtain regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety profile of our products. These and other risks, uncertainties and factors related to Glaukos, and our business are described in detail under the caption “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 23, 2024. Our filings with the SEC are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Media Contact – Glaucoma:

Stefanie Tuck

(978) 390-1394

stefanie@jpa.com

Investor Contact:

Chris Lewis

Vice President, Investor Relations & Corporate Affairs

(949) 481-0510

clewis@glaukos.com

Source: Glaukos Corporation

The new J-code assigned to iDose TR by CMS is J7355, set to become effective on July 1, 2024.

The purpose of the J-code for iDose TR is to enhance patient access in the U.S. and streamline billing and reimbursement processes.

The CPT codes assigned to cover the procedural component of iDose TR are 0660T and 0661T.

iDose TR is a first-of-its-kind, long-duration intracameral procedural pharmaceutical therapy designed to deliver continuous therapeutic levels of travoprost inside the eye, aiming to improve patient compliance and reduce side effects associated with topical glaucoma medications.
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About GKOS

glaukos corporation is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures to transform the treatment of glaucoma, one of the world’s leading causes of blindness. glaukos has pioneered micro-invasive glaucoma surgery, or migs, to revolutionize the traditional glaucoma treatment and management paradigm. the company launched the istent trabecular micro-bypass stent, its first migs device, in the united states in 2012. glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of injectable micro-scale therapies designed to address the complete range of glaucoma disease states and progression. glaukos believes the istent is the smallest medical device ever approved by the food and drug administration, or fda, measuring 1.0 mm long and 0.33 mm wide. in june 2015, the company completed an initial public offering and its shares are now traded on the new york stock exchange unde