Riboflavin 5'-Phosphate Sodium

Commencement of Subject Enrollment in Epioxa™ Phase 3 Confirmatory Trial Promising Phase 2a Results for GLK-301 (iLution – Dry Eye Disease) Support Planned Phase 2b Study to Commence in 2023 ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced positive clinical updates for several of its Corneal Health pipeline programs, including the commencement of subject enrollment in a second Phase 3 confirmatory trial for Epioxa™ (Epi-on™), and promising initial results from the company’s Phase 2a clinical trial for GLK-301 (iLution - Dry Eye Disease). “These clinical updates represent meaningful milestones for two of our key Corneal Health pipeline programs and we look forward to continuing to advance both of these important programs forward in 2023,” said Thomas Burns, Glaukos chairman and chief executive officer. “We continue to successfully invest in and advance our robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.” Glaukos commenced subject enrollment in its second Phase 3 confirmatory pivotal trial for Epioxa (Epi-on), its next-generation corneal cross-linking therapy for the treatment of keratoconus. Glaukos plans to randomize approximately 290 subjects in this trial and is targeting enrollment completion by the end of 2023. As a reminder, the U.S. Food and Drug Administration (FDA) has confirmed Glaukos’ first Phase 3 pivotal trial for Epioxa, which met the pre-specified primary efficacy endpoint, would be adequate to support the submission and review of an eventual New Drug Application (NDA), in conjunction with this second trial. As Glaukos continues to advance its clinical plans for Epioxa, it remains well-positioned to serve keratoconus patients with its first-generation corneal cross-linking therapy, Photrexa®, or Epi-off™, which remains the only FDA-approved treatment shown to slow and halt the progression of keratoconus. Glaukos also announced promising topline results from its Phase 2a first-in-human clinical trial for GLK-301 (iLution – Dry Eye Disease (DED)) for the signs and symptoms of DED. GLK-301 is a sterile ophthalmic topical cream to be applied to the eyelids for the treatment of signs and symptoms of DED. The trial’s endpoints included the evaluation of multiple signs and symptoms characteristic of DED. Topline Phase 2a outcomes for GLK-301 demonstrated improvement in the quality of tear film (tear break-up time) with corresponding improvement in quality of vision (reduction in blurred vision). Based on these encouraging observations, Glaukos plans to advance GLK-301 into a Phase 2b clinical trial targeted to begin in 2023. The Phase 2a multi-center, randomized, double-masked, placebo-controlled trial enrolled 218 subjects across clinical sites in the United States and was designed to evaluate the safety and efficacy of three different dose levels of GLK-301 administered twice daily (BID) to the eyelids versus placebo over 28 days, followed by a 14-day safety follow-up period, in subjects diagnosed with DED. GLK-301 is the first investigational drug candidate utilizing Glaukos’ iLution platform’s patented cream-based drug formulations that are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. The cream formulation acts as a depot allowing pilocarpine to be delivered through the dermis of the eyelid to the eye. About Glaukos Glaukos ( ) is an ophthalmic medical technology and pharmaceutical 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. 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 we obtain regulatory approval for investigational products such as Epioxa or GLK-301, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for this product, and the continued efficacy and safety pro this product as reported in the pivotal trials and other clinical studies. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on November 4, 2022. 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.

Sept. 28, 2022 11:00 UTC ALISO VIEJO, Calif.--(BUSINESS WIRE)-- Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today that its technologies will be featured in various scientific programming at the American Academy of Ophthalmology (AAO) annual meeting, being held September 30 - October 3, 2022 in Chicago, IL. Key Glaucoma Presentations: Bryan CH Ang, MD Novel Use of the Intraoperative OCT in Trabecular Bypass Minimally Invasive Glaucoma Surgery Fritz H. Hengerer, MD Trabecular Micro-Bypass +/- Cataract Surgery Shows 5-Year Efficacy and Safety in Eyes Regardless of Prior Glaucoma Surgery Jed Lusthaus, MBBS Analysis of the Relationship Between IOP and Aqueous Outflow as Assessed by Hemoglobin Video Imaging After Trabecular Bypass Surgery With iStent Inject® Thomas W. Samuelson, MD Endothelial Safety Pro MIGS Stents Inder Paul Singh, MD Trabecular Micro-Bypass for IOP Reduction in Glaucoma Uncontrolled by Prior Surgical or Medical Therapy (Prospective Multicenter Pivotal Trial of iStent Infinite®) Key Glaucoma Course: Steven R. Sarkisian, MD MIGS: Devices and Incisional Techniques Key Glaucoma Symposium: Oluwatosin U. Smith, MD and Qi N. Cui, MD New Devices in Glaucoma Key Corneal Health Presentations: Eric Kim Effectiveness of CXL in Young Patients Katherin S. Peters, MD Racial Disparities in KC: Presentation Severity and Treatment Outcomes Key Corneal Health Courses: J. Bradley Randleman, MD Advanced Corneal Topographic Analysis Audrey R. Talley Rostov, MD Corneal Edema, Opacifications, Ectasia and Bacterial Keratitis: Diagnosis and Treatment Strategies from the Preferred Practice Pattern Guidelines Key Corneal Health Symposium: Loretta Szczotka-Flynn OD, Ph.D. and Mark A. Kontos, MD The Life Cycle of Keratoconus: From Diagnosis to Treatment and Lifetime Management (joint session with the American Academy of Optometry) Abstracts and full session details can be found at . Glaukos will also be exhibiting on the showroom floor throughout AAO at booth #4503. The AAO Annual Meeting is among the largest gatherings of ophthalmic physicians, medical personnel, and industry executives in the ophthalmic industry. All educational content of the AAO Annual Meeting is planned by its program committee, and AAO does not endorse, promote, approve or recommend the use of any products, devices or services. About Glaukos Glaukos ( ) is an ophthalmic medical technology and pharmaceutical 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 iStent inject W Trabecular Micro-Bypass System (U.S.) Indication for Use: The iStent inject W Trabecular Micro-Bypass System Model G2-W is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma. Contraindications: The iStent inject W is contraindicated in eyes with angle-closure glaucoma, traumatic, malignant, uveitic, or 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 of the angle that could lead to improper placement of the stent and pose a hazard. MRI Information: The iStent inject W 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. The safety and effectiveness of the iStent inject W have not been established as an alternative to the primary treatment of glaucoma with medications, in children, in eyes with significant prior trauma, abnormal anterior segment, chronic inflammation, prior glaucoma surgery (except SLT performed > 90 days preoperative), glaucoma associated with vascular disorders, pseudoexfoliative, pigmentary or other secondary open-angle glaucomas, pseudophakic eyes, phakic eyes without concomitant cataract surgery or with complicated cataract surgery, eyes with medicated IOP > 24 mmHg or unmedicated IOP < 21 mmHg or > 36 mmHg, or for implantation of more or less than two stents. Adverse Events: Common postoperative adverse events reported in the iStent inject randomized pivotal trial included stent obstruction (6.2%), intraocular inflammation (5.7% for iStent inject vs. 4.2% for cataract surgery only), secondary surgical intervention (5.4% vs. 5.0%) and BCVA loss ≥ 2 lines ≥ 3 months (2.6% vs. 4.2%). 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 . About Photrexa® Viscous and Photrexa Indications: Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL® System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Important Safety Information: Corneal collagen cross-linking should not be performed on pregnant women. Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects. The most common ocular adverse reaction was corneal opacity (haze). Other ocular side effects include punctate keratitis, corneal striae, dry eye, corneal epithelium defect, eye pain, light sensitivity, reduced visual acuity and blurred vision. These are not all of the side effects of the corneal collagen cross-linking treatment. For more information, go to to obtain the FDA-approved product labeling. Photrexa Viscous and Photrexa are manufactured for Avedro. The KXL System is manufactured by Avedro. Avedro is a wholly owned subsidiary of Glaukos Corporation. 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 AAO 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, which was filed with the Securities and Exchange Commission (SEC) on August 5, 2022. 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.