Corneal Endothelial Cell Loss

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 ( ) 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 pro 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 or at . In addition, information about the risks and benefits of our products is available on our website at . 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. View source version on businesswire.com: Contacts 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 View this news release online at:

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, announced today that it will present multiple scientific abstracts at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting, being held April 5-8, 2024 in Boston, MA. Glaukos will be exhibiting onsite at booth #631. In addition, Glaukos is sponsoring an educational symposium in conjunction with ASCRS and EyeWorld entitled, “The Catalysts to Advance the Interventional Glaucoma Revolution: iDose® TR (travoprost intracameral implant) 75 mcg and iStent infinite®” on Friday, April 5, 2024, at 12:00-1:00 p.m. ET in Room 252AB at the Boston Convention & Exhibition Center. The faculty includes Ike Ahmed, MD (Moderator); Sahar Bedrood, MD; John Berdahl, MD; Manjool Shah, MD; and Blake Williamson, MD. Go here for more information and to register. Key Glaucoma Presentations: Saturday, April 6, 2024 10:28-10:33 a.m., I. Paul Singh, MD Efficacy of Travoprost Intraocular Implant in Diverse Subpopulations of Patients with Open-Angle Glaucoma or Ocular Hypertension 10:33-10:38 a.m., Christy Benson, MD Early Outcomes After Third-Generation Trabecular Micro-Bypass with/without Goniotomy in Eyes with Failed Prior Glaucoma Intervention 10:33-10:38 a.m., Cristos Ifantides, MD, MBA Two-Year Comparison of 2 Trabecular MIGS Devices in Patients with Mild to Severe Open-Angle Glaucoma 10:38-10:43 a.m., Steven Sarkisian, MD Standalone Procedure of Administration of Travoprost Intraocular Implant is Safe and Effective in Phakic Eyes 10:43-10:48 a.m., Rom Kandavel, MD 12-Month Efficacy Results of Trabecular Micro-Bypass in Patients Stratified by Prior Laser or Incisional Glaucoma Surgery 10:51-10:56 a.m., John Berdahl, MD Travoprost Intraocular Implant in Eyes with Prior Selective or MicroPulse Laser Trabeculoplasty Sunday, April 7, 2024 8:50-8:55 a.m., Ali Salimi, MD A Decade-Long Outcomes of Two First-Generation Trabecular Micro-Bypass Stents with Cataract Surgery in Primary Open-Angle Glaucoma 9:05-9:10 a.m., Mitchell Schultz, MD Preliminary Outcomes of 3 Microstents as Trabecular MIGS Device with or without Canaloplasty in Mild and Moderate Open-Angle Glaucoma Key Glaucoma Posters: Jason Bacharach, MD Travoprost Intraocular Implant: Analysis of Topical Prostaglandin Analog-associated Adverse Events Fritz Hengerer, MD 7-Year Outcomes after Second-Generation Trabecular Micro-Bypass in Eyes with or without Prior Glaucoma Surgery Brittany Long Comparison of Two Different MIGS Devices with Combined Canaloplasty in Moderate Glaucoma at the Time of Cataract Surgery Deborah Ristvedt, DO Third-Generation Trabecular Micro-Bypass in Eyes Failing Prior Surgical and/or Medical Glaucoma Therapy Valerie Trubnik, MD Usage of Three Trabecular Mico-Bypass Stents Combined with Phacoemulsification in Surgically Naïve Glaucoma Patients Zachary Vest, MD Early Outcomes After Third-Generation Trabecular Micro-Bypass Performed with Phacoemulsification in Patients with Open-Angle Glaucoma Edward Yung, MD Outcomes after Viscoelastic Delivery in Patients with Glaucoma Key Corneal Health Presentations: Friday, April 5, 2024 9:13-9:21 a.m., Michael Raizman, MD Cross-Linking – Now and What’s Coming Saturday, April 6, 2024 3:31-3:41 p.m., Brandon Ayres, MD Keratoconus – Surgical Innovations Sunday, April 7, 2024 10:00-10:05 a.m., Kenneth Beckman, MD Safety of a Scanning Laser-based Bioactivation System for Corneal Cross-Linking in Keratoconus Abstract information can be found at . The ASCRS Annual Meeting is among the largest gatherings of anterior segment physicians, medical personnel and industry executives in the ophthalmic industry. All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve or recommend the use of any products, devices or services. About Glaukos Glaukos ( ) 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. About iStent infinite® Trabecular Micro-Bypass System (U.S.) Indication for Use: The iStent infinite Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. Contraindications: The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. Warnings: Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI Information: The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. Precautions: The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. Adverse Events: The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). Caution: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events. For more information, visit . 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 timing and extent to which 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 pro our products as might be suggested in the presentations at the ASCRS meeting. 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 or at . In addition, information about the risks and benefits of our products is available on our website at . 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.

DALLAS--(BUSINESS WIRE)-- Celanese Corporation (NYSE: CE), a global specialty materials and chemical company, announced the launch of iDose® TR by Glaukos Corporation using Celanese’s VitalDose® EVA to provide sustained drug release for the treatment of glaucoma. The majority of glaucoma and ocular hypertension patients are non-compliant with topical medication use due to complex dosing regiments, side effects, and eye-drop intolerance. Sustained delivery of therapeutics provides an important approach in addressing non-compliance and improving treatment outcomes. With iDose® TR and the VitalDose® EVA, there is now the opportunity to provide continuous dosing which can improve patient compliance and address adherence issues. iDose® TR was approved by the Food and Drug Administration (FDA) in December 2023 and 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 was approved on the basis of two pivotal trials (1,150 subjects randomized across both trials), which demonstrated safety and efficacy. Glaukos used the VitalDose® EVA to create a nanoporous membrane for travoprost delivery in iDose® TR. The VitalDose® EVA is a platform that can be formulated into a wide range of form factors to suit drug delivery needs for various conditions. “A clear unmet need exists in ophthalmology for therapies that address non-compliance and reduce the treatment burden for patients,” says Cyonna Holmes, global business strategy leader for Ophthalmology and RNA at Celanese. “Our team is excited to support Glaukos as they transform the landscape of glaucoma treatment for millions of patients.” The VitalDose® EVA Drug Delivery Platform provides reliable, controlled-release performance and has a long history of use in approved parenteral drug products in the United States and Europe. For more information on Celanese VitalDose® technology, visit . About Celanese Celanese is a global leader in chemistry, producing specialty material solutions used across most major industries and consumer applications. Our businesses use our chemistry, technology and commercial expertise to create value for our customers, employees and shareholders. We are committed to sustainability by responsibly managing the materials we create for their entire lifecycle and are growing our portfolio of sustainable products to meet increasing customer and societal demand. We strive to make a positive impact in our communities and foster inclusivity across our teams. Celanese is a Fortune 500 company that employs approximately 12,400 employees worldwide with 2023 net sales of $10.9 billion. iDose TR Indication and Important Safety Information INDICATIONS AND USAGE 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.