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Item 7.01. Regulation FD Disclosure.
On December 14, 2023, Glaukos Corporation (the “Company”) issued a press release announcing the approval of its iDose® TR (travoprost intracameral implant) by the U.S. Food & Drug Administration. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
A presentation containing supplemental information on the iDose TR is furnished as Exhibit 99.2 to this Current Report on Form 8-K (the “Presentation”). The Presentation will also be available on the investor page of the Company’s website at http://investors.glaukos.com.
The information contained in this Item 7.01 and in the accompanying Exhibits 99.1 and 99.2 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press Release of Glaukos Corporation dated December 14, 2023 | |
99.2 | iDose TR FDA Approval Presentation dated December 14, 2023 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
GLAUKOS CORPORATION (Registrant) | |||
By: | /s/ Alex R. Thurman | ||
Name: | Alex R. Thurman | ||
Title: | Senior Vice President & Chief Financial Officer |
Date: December 14, 2023
Exhibit 99.1
FOR IMMEDIATE RELEASE
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
Glaukos Announces FDA Approval of iDose® TR (travoprost intracameral implant)
Revolutionary, micro-invasive, injectable treatment for the full range of glaucoma disease severity
iDose TR was designed to usher in a new era of interventional glaucoma by enabling a proactive approach with a safe, effective, and durable therapy for patients in need
FDA approval based on robust Phase 3 clinical program consisting of two pivotal studies that randomized 1,150 subjects across 89 clinical sites
Glaukos to host a conference call on December 14, 2023, at 8:30 a.m. ET / 5:30 a.m. PT
Aliso Viejo, CA –December 14, 2023 – 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 the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for a single administration per eye of 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).
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.
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“The FDA approval of iDose TR represents a significant milestone for Glaukos following an extensive pioneering journey since the inception of the original idea nearly 15 years ago. Today’s approval ushers in a new era of interventional glaucoma therapy by enabling a more proactive and reliable approach for patients in need,” said Thomas Burns, Glaukos chairman and chief executive officer. “We believe iDose TR can be a transformative, novel technology able to fundamentally improve the treatment paradigm for patients with open-angle glaucoma or ocular hypertension. We are grateful to the clinical investigators and study participants in the clinical trials for their instrumental roles in helping us reach this important advancement for glaucoma patient care. At Glaukos, we are relentlessly focused on delivering novel therapies for chronic eye diseases and now iDose TR has the potential to redefine the standard of care for patients in the U.S. affected by open-angle glaucoma and ocular hypertension.”
“With the next generation of procedural pharmaceutical solutions for glaucoma such as iDose TR, we now have a new tool that will confront the standard legacy practice of relying on topical drops, which are known to cause uncomfortable side effects and present a myriad of challenges such as treatment adherence, complex dosing regimens, and difficulty with self-administration,” said John Berdahl, MD, clinician and researcher at Vance Thompson Vision. “The clinical data suggest that iDose TR is not only effective with a favorable safety profile, but it has potential to relieve patients from the burdens of prescription eye drops for an extended period of time. I look forward to adding this novel therapy into my treatment toolbox for the benefit of my patients.”
The FDA approval is based on results from two prospective, randomized, multicenter, double-masked, Phase 3 pivotal trials (GC-010 and GC-012) designed to compare the safety and efficacy of a single administration of one of two iDose TR models with different travoprost release rates (referred to as the fast- and slow-release iDose TR models, respectively) to topical timolol ophthalmic solution, 0.5% BID (twice a day), in reducing IOP in subjects with open-angle glaucoma or ocular hypertension. In total, the Phase 3 trials randomized 1,150 subjects across 89 clinical sites. The FDA approval and Phase 3 data referenced below is for the slow-release iDose TR model, consistent with the company’s NDA submission and commercialization plans.
Both Phase 3 trials successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. IOP reductions from baseline over the first 3 months were 6.6-8.4 mmHg in the iDose TR arm, versus 6.5-7.7 mmHg in the timolol control arm (mmHg range represents IOP reduction means across the six U.S. FDA pre-specified timepoints of 8 a.m. and 10 a.m. at Day 10, Week 6 and Month 3). Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. The FDA also noted that subsequently iDose TR did not demonstrate non-inferiority over the next 9 months.
At 12 months, 81% of iDose TR subjects were completely free of IOP-lowering topical medications across both trials. In both trials, iDose TR demonstrated excellent tolerability and subject retention with 98% of iDose TR subjects continuing in the trial at 12 months, versus 95% of timolol control subjects. In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of iDose TR patients were increases in intraocular pressure, iritis, dry eye, and visual field defects, most of which were mild and transient in nature.
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iDose TR is also supported by positive results from a Phase 2b clinical trial, which were recently highlighted in a peer-reviewed publication in Drugs (link here). The study authors concluded, “The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile.”
Glaukos intends to commence initial commercial launch activities for iDose TR in the latter part of the first quarter of 2024. Glaukos has established a wholesale acquisition cost for iDose TR of $13,950, per dose (or implant).
Alongside the iDose TR approval announcement, Glaukos is proud to introduce the iDose Your Dose Initiative. For every iDose TR sold, Glaukos pledges to make available an equal number of iDose TR units for qualifying charitable donation requests in the U.S. and around the globe for recipients that satisfy independent eligibility requirements.
For more information about iDose TR and Full Prescribing Information, please visit www.iDoseTRhcp.com.
2023 and 2024 Revenue Guidance
The company reaffirms its 2023 net sales range of $307 million to $310 million and introduces preliminary 2024 net sales guidance range of $350 million to $360 million.
Webcast & Conference Call
The company will host a conference call and simultaneous webcast on December 14, 2023, at 8:30 a.m. ET (5:30 a.m. PT) to discuss the FDA approval of iDose TR. A link to the webcast is available on the company’s website at http://investors.glaukos.com. To participate in the conference call, please dial 888-210-2212 (U.S.) or 646-960-0390 (international) and enter Conference ID 7935742. A replay of the webcast will be archived on the company’s website following completion of the call.
About iDose TR
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.
About Glaukos
Glaukos (www.glaukos.com) 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.
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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.
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 are able to obtain regulatory approval for investigational products, our ability to successfully commercialize and generate sales of our products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, our ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in the use of our products, our ability to compete successfully in the pharmaceutical industry, which is highly competitive and rapidly changing, our compliance with federal and state laws and regulations for the approval, sale and marketing of our products and our manufacturing processes, the lengthy and expensive clinical trial process and the uncertainty of timing and outcomes from any particular clinical trial or regulatory approval processes, and the continued efficacy and safety profile of our products 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, 2023, which was filed with the Securities and Exchange Commission (SEC) on November 1, 2023. 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.
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Exhibit 99.2
© 2023 Glaukos Corporation Page 1 FDA Approval CONFERENCE CALL & WEBCAST December 14, 2023 (travoprost intracameral implant 75 mcg)
© 2023 Glaukos Corporation Page 2 © 2023 Glaukos Corporation Page 2 Glaukos Participants Tom Burns Chairman & CEO Joe Gilliam President & COO Alex Thurman Sr. VP & Chief Financial Officer Tomas Navratil, Ph.D. Chief Development Officer Chris Lewis VP, Investor Relations & Corporate Affairs
© 2023 Glaukos Corporation Page 3 All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward - looking statements . These statements are based on management’s current expectations, assumptions, estimates and beliefs . 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 presentation . These potential risks and uncertainties that could cause actual results to differ materially from those described in forward - looking statements include, without limitation, uncertainties regarding the duration and severity of the COVID - 19 pandemic and its impact on our business or the economy ; the impact of general macroeconomic conditions including foreign currency fluctuations ; the reduced physician fee and ASC facility fee reimbursement rate finalized by CMS for 2022 and 2023 for procedures utilizing the Company’s iStent family of products and its impact on our U . S . combo - cataract glaucoma revenue ; our ability to continue to generate sales of our commercialized products and develop and commercialize additional products ; our dependence on a limited number of third - party suppliers, some of which are single - source, for components of our products ; the occurrence of a crippling accident, natural disaster, pandemic or other disruption at our primary facility, which may materially affect our manufacturing capacity and operations ; securing or maintaining adequate coverage or reimbursement by government or third - party payors for procedures using the iStent ®, the iStent inject® W , iAccess , iPRIME, iStent infinite, iDose® TR, our corneal cross - linking products or other products in development ; our ability to properly train, and gain acceptance and trust from, ophthalmic surgeons in the use of our products ; our ability to compete effectively in the highly competitive and rapidly changing medical device industry and against current and future technologies (including MIGS technologies) ; our compliance with federal, state and foreign laws and regulations for the approval and sale and marketing of our products and of our manufacturing processes ; the lengthy and expensive clinical trial process and the uncertainty of timing and outcomes from any particular clinical trial or regulatory approval processes ; the risk of recalls or serious safety issues with our products and the uncertainty of patient outcomes ; our ability to protect, and the expense and time - consuming nature of protecting, our intellectual property against third parties and competitors and the impact of any claims against us for infringement or misappropriation of third party intellectual property rights and any related litigation ; and our ability to service our indebtedness . These and other known risks, uncertainties and factors are described in detail under the caption “Risk Factors” and elsewhere in our filings with the Securities and Exchange Commission (SEC), including our Quarterly Report on Form 10 - Q for the quarter ended September 30 , 2023 , which was filed with the SEC on November 1 , 2023 . 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 presentation 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 presentation, 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 . Disclaimer
© 2023 Glaukos Corporation Page 4 iDose® TR is approved by the FDA Revolutionary, micro - invasive, injectable treatment for the full range of glaucoma disease severity First - ever long duration procedural pharmaceutical designed to deliver up to 3 years of glaucoma drug therapy
© 2023 Glaukos Corporation Page 5 iDose TR: Groundbreaking Glaucoma Advancement Insertion System Precision - engineered to facilitate straightforward implantation Fixed and Stable Securely anchored into scleral tissue for drug elution directly into the anterior chamber Unique Drug Formulation 75 mcg of a novel, proprietary, preservative - free travoprost formulation; ~25,000x more concentrated than leading PGA medications (0.004% in Travatan Z) Novel Membrane Nanoporous, ethylene - vinyl acetate (EVA) membrane designed for continuous drug elution Designed to provide 24/7, continuous, long - duration drug therapy to address ubiquitous patient non - compliance with topical medications <0.5mm 1.8mm
© 2023 Glaukos Corporation Page 6 © 2023 Glaukos Corporation Page 6 iDose TR Prescribing Information iDose TR is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open - angle glaucoma (OAG) or ocular hypertension (OHT) INDICATIONS AND USAGE CLINICAL TRIALS – EFFICACY In the first 3 months following administration, iDose TR demonstrated an IOP change from baseline of - 6.6 to - 8.4 mmHg in the study eye of patients with a mean baseline IOP of 24 mmHg. iDose TR demonstrated non - inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. Subsequently, iDose TR did not demonstrate non - inferiority over the next 9 months. CLINICAL TRIALS – SAFETY The most common ocular adverse reactions reported in 2% to 6% of patients were increases in IOP, iritis, dry eye, and visual field defects. DOSAGE FORMS AND STRENGTHS Intracameral implant containing 75 mcg travoprost, pre - loaded in a single - dose inserter. GENERAL DOSING INFORMATION iDose TR is a travoprost delivery system consisting of a travoprost releasing implant pre - loaded in a sterile, single - dose inserter. iDose TR is administered intracamerally through a small, clear corneal incision and is anchored into the sclera at the iridocorneal angle. iDose TR should not be readministered to an eye that received a prior iDose TR. 1 1 The company intends to engage with the FDA in the near - future to explore label expansion opportunities to include repeat admini stration over time
© 2023 Glaukos Corporation Page 7 iDose TR: Addresses Important Clinical Needs Topical medications are the dominant treatment plan for the roughly 18M US eyes 1 affected by glaucoma and ocular hypertension Research 2 shows that >90% of patients are non - compliant with medication use ~50% purposely discontinue their medication(s) within 6 months & High rates of non - compliance and non - adherence to topical medications contribute to disease progression Complex dosing regimens, instillation difficulties and chronic side effects associated with topical meds undermine patient compliance and quality of life • Hyperemia • Periorbital fat atrophy • Ocular surface disease • Hyperchromia 1 Based on company analysis of Market Scope, Medicare Claims and IMS Health Compliance data 2 Nordstrom BL, Friedman DS, Mozaffari E, Quigley H, Walker AM. Persistence and adherence with topical glaucoma therapy. Am J O ph thalmol. 2005;140(4): 598 - 606
© 2023 Glaukos Corporation Page 8 iDose TR: Phase 3 Data Validates Game - Changing Potential IOP Reductions from Baseline (mmHg) 8.5 6.6 7.7 6.5 6.7 8.4 6.8 7.2 Timolol 0.5% BID iDose TR 1 mmHg range represents IOP reduction means across the 6 US FDA pre - specified timepoints of 8AM and 10AM at Day 10, Week 6 and Month 3 In 2 pivotal trials (1,150 subjects randomized across both trials), iDose TR achieved pre - specified primary efficacy endpoints as agreed upon with US FDA (non - inferiority to topical timolol through 3 months) Statistically significant superior IOP - lowering vs pre - study PGAs in sub - group analysis of combined Phase 3 trials IOP VALUES ON PRE - STUDY PGAs, AFTER PGA WASHOUT, AND AT 3 MONTHS OF iDOSE TR IOP (mmHg) 10 12 14 16 18 20 22 24 Pre-Study PGA After Washout (Remove pre- study PGA) 18.0 mmHg 16.7 mmHg 23.8 mmHg Pre - study PGAs: - 5.8 mmHg In - Study iDose TR: - 7.1 mmHg ( Δ 1.3 mmHg vs pre - study PGAs, p = 0.0003) • 125 subjects across both Phase 3 trials were on a single PGA IOP - lowering med at screening • After 4 - week washout (PGAs removed), IOP rose to 23.8 mmHg, showing pre - study PGA efficacy of - 5.8 mmHg • After iDose TR administration, IOP decreased to 16.7 mmHg at 3 months, showing iDose TR in - study efficacy of - 7.1 mmHg • iDose TR demonstrated 1.3 mmHg statistically significant superior IOP - lowering vs pre - study PGAs (p = 0.0003) Month 3 IOP REDUCTIONS FROM BASELINE OBSERVED DURING FIRST 3 MONTHS 1
© 2023 Glaukos Corporation Page 9 iDose TR: Phase 3 & Phase 2b Data Confirm Long Duration AT 12 MONTHS AT 24 MONTHS AT 36 MONTHS PH 3 93% PH 2B 92% 72% 69% of iDose TR subjects in the Phase 3 trials were completely free of IOP - lowering topical medications at 12 months 81% % OF iDOSE TR SUBJECTS WELL - CONTROLLED 1 ON THE SAME OR FEWER IOP - LOWERING TOPICAL MEDICATIONS % PATIENTS WELL CONTROLLED 1 ON THE SAME OR FEWER TOPICAL IOP - LOWERING MEDS IN PHASE 2B TRIAL AT 3 YEARS 69% 45% Timolol 0.5% BID 1 Well - controlled patients were prospectively defined in the clinical study protocol as those with IOP was ≤ 18 mmHg in the Phase 2B trial. In the Phase 3 trials, they were defined as those with IOP ≤ 22 mmHg, or > 22 and ≤ 25 mmHg with a reduction of ≥20% from baseline. Patients above these values were treated with the addition of a topical IOP - lowering medication .
© 2023 Glaukos Corporation Page 10 iDose TR shown to deliver therapeutically relevant and durable drug concentrations through 24 months iDose TR Pharmacokinetic Clinical Study Results Open label, single - center study to determine in - patient drug elution rate and aqueous humor (AH) exposure to travoprost free acid (TFA) 210 iDose TR patients were followed for 3 - 24 months At pre - determined timepoints, iDose TR was removed and analyzed for remaining levels of travoprost in the implants. AH was collected and analyzed for TFA concentrations 5 3.7 5.6 2 2.2 3.8 3.3 3 Months 6 Months 12 Months 15 Months 18 Months 21 Months 24 Months ng/mL MEAN TFA CONCENTRATIONS Mean TFA levels were above C MAX concentration of TFA (1.78 ng/mL) determined after the dosing of topical travoprost; levels were also above efficacious TFA level (95 pg/mL) estimated after intracameral implant dosing of travoprost 79% 70% 50% 39% 35% 28% 16% 3 Months 6 Months 12 Months 15 Months 18 Months 21 Months 24 Months AVG AMOUNT OF TRAVOPROST REMAINING FOLLOWING EXPLANTATION % Of Travoprost At 24 months, iDose TR implants still contained 16% of the travoprost drug product Data abstract submitted for presentation at ARVO 2024 Annual Meeting
© 2023 Glaukos Corporation Page 11 Ph 3 Trials 1 Year Ph 2b Trial 3 Years Topical PGAs No adverse events of periorbital fat atrophy Up to 70% incidence Very low conjunctival hyperemia 30% - 50% incidence No adverse events of corneal endothelial cell loss Very low or no incidence of iris color change ~20% incidence iDose TR: Phase 3 & Phase 2b Results Show Excellent Safety PHASE 3 AND PHASE 2B SAFETY DATA FDA APPROVAL: PRESCRIBING SAFETY INFORMATION In controlled studies, the most common ocular adverse reactions in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, and visual field defects.
© 2023 Glaukos Corporation Page 12 iDose TR: Building a Robust Body of Published Clinical Evidence 1 12 16+ Planned peer - reviewed articles to cover wide range of relevant data, including: • iDose TR efficacy and safety in managing IOP and reducing topical medication burden • Comparison of iDose TR to twice - daily timolol regimen • Efficacy and safety of iDose TR in diverse subpopulations • Efficacy and safety in iDose TR subjects with and without prior SLT • In - office administration of iDose TR submissions to leading medical journals currently accepted, under review or in process external authors actively engaged in data analysis and manuscript preparation Article published and available online ahead of print at https://pubmed.ncbi.nlm.nih.gov/38060092 (iDose TR Ph2b 3 - year follow up results)
© 2023 Glaukos Corporation Page 13 iDose TR: Major Addition to Interventional Glaucoma Arsenal GLAUCOMA THERAPY Designed to provide 24/7 long - duration sustained release of travoprost directly into the anterior chamber; for full range of disease progression Up to 240 of powerful outflow coverage for patients who failed prior medical and surgical therapy COMBO - CATARACT ONLY Creates 2 pathways for fluid outflow; wider flange enhances ease of use and visibility Glaukos is uniquely positioned to lead development of the Interventional Glaucoma opportunity
© 2023 Glaukos Corporation Page 14 iDose TR Extensive Development Journey – Major Milestones 2008 - 2013 2014 - 2018 2019 - 2023 Dedicated 15+ years from ideation to commercialization Formulated unique, potent, long - lasting prostaglandin to achieve therapeutic index and stability Developed micro - scale EVA membrane to achieve predictable, targeted elution rate Commenced development of next - generation iDose platform technologies, including iDose TREX Conducted foundational Proof of Concept (POC) and Phase 2 clinical trials Int’l pilot, POC, prospective study led to open IND; Phase 2 randomized study provided preliminary safety and efficacy results to progress to Phase 3 Began fortifying in - house pharmaceutical expertise Ongoing expansion of experienced pharma research, development, clinical and regulatory teams charged with advancing iDose TR and the iDose platform Invested over $500 million in new innovations Total R&D investment (2018 - 2023) to advance iDose TR and other innovations, representing 30%+ of revenues Enrolled 1,150 subjects in rigorous Phase 3 clinical trials Overcame numerous logistical challenges related to implementing major trials during COVID pandemic Submitted ~100,000 - page NDA for iDose TR approval Comprehensive filing to CDRH and CDER resulted in FDA approval Built state - of - the - art nanomanufacturing capabilities Highly specialized facilities, equipment and expertise created from the ground up, followed by completion of the required PAI with no 483 observations
© 2023 Glaukos Corporation Page 15 iDose TR Extensive Development Journey – Manufacturing Buildout State - of - the - art nanomanufacturing facilities and equipment, meeting appropriate regulatory, CMC and ISO 7 guidelines Manufacturing Facilities San Clemente, CA Multi - year effort to establish approximately 134K sq ft of manufacturing, warehouse and office space dedicated to iDose TR commercialization
© 2023 Glaukos Corporation Page 16 iDose TR – Preparing for Commercialization Glaukos has become a leader in micro - scale manufacturing, with +20 years of experience , and using ISO 7 manufacturing environment with terminal sterilization
© 2023 Glaukos Corporation Page 17 © 2023 Glaukos Corporation Page 17 iDose TR Commercial Launch Strategy * Market opportunity estimate based on Glaukos algorithm of physician preference, utilization; assumes up to 3 - year iDose TR therapy duration Apply for permanent J - Code Methodical, controlled launch commences Surgeon training begins, focused on glaucoma specialists Establishment of Cat III CPT code (0660T) for facility (APC classification) Anticipate permanent J - code in 2H 2024 Accelerate marketing investments as universe of trained surgeons expands and market access is established Annual Opportunity of ~1M eyes* Establishment of Cat III CPT code (0660T) for pro fees (MAC by MAC)
© 2023 Glaukos Corporation Page 18 © 2023 Glaukos Corporation Page 18 iDose TR Commercial Launch Strategy Initially positioned for patients who can receive strong clinical benefit from this unique therapy: x Non - compliant glaucoma patients x Glaucoma patients who are intolerant to topical glaucoma drops x Glaucoma patients with underlying co - morbidities (e.g., dry eye) x Glaucoma patients who have physical limitations that impede their ability to utilize eye drops x Glaucoma patients who are seeking to reduce drug burden and/or have experienced decreased quality - of - life related to topical drug use Leverage large, well - established US glaucoma commercial organization Regional business and academic managers ~ 70 Total US glaucoma commercial personnel 100+
© 2023 Glaukos Corporation Page 19 Procedural Pharmaceuticals – Range of Annual WAC Pricing (Per Eye) $3,000 and below $5,000 $10,000 $15,000 $20,000 and higher GLAUCOMA RETINAL DISEASES OTHER At a WAC price of $13,950, iDose TR is among the most cost - effective procedural pharmaceuticals in ophthalmology when annualized based on its design to deliver up to 3 - years of drug therapy 1 1 Berdahl, JP et al, Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP - Lowering Medication Burden in Patients with Op en - Angle Glaucoma or Ocular Hypertension, Drugs December 2023; https://pubmed.ncbi.nlm.nih.gov/38060092
© 2023 Glaukos Corporation Page 20 Enabling Patient Access is Critical REIMBURSEMENT LIAISON • Patient Counseling • Benefit Verification • Denials and Appeals • BV Portal • Billing and Coding Support • Policy Reviews CO - PAY ASSISTANCE PROGRAM SPECIALTY PHARMACY BILLING & CODING SUPPORT
© 2023 Glaukos Corporation Page 21 PROGRAM We created the iDose Your Dose philanthropic initiative. For every iDose TR sold, Glaukos pledges to make available an equal number of iDose TR units for qualifying charitable donation requests around the globe.* Corporate Philanthropy – iDose Your Dose MISSION Provide broad patient access to transformative, dropless therapy that can meaningfully impact the lives of all patients living with glaucoma. * Recipients of Glaukos product donations must satisfy independent eligibility requirements.
© 2023 Glaukos Corporation Page 22 © 2023 Glaukos Corporation Page 22 2023 and 2024 Revenue Guidance $350 - $360 MILLION Highly preliminary FY2024 revenue guidance that factors in iDose launch plans, MIGS combo - cataract and iStent infinite landscape, as well as International Glaucoma and Corneal Health expectations Expect to refine guidance range and provide incremental commentary during our 4Q23 earnings call in February 2024 $307 - $310 MILLION Affirmed FY2023 revenue guidance range
Innovation is at the core of everything we do. At Glaukos, we push the limits of science and technology to solve unmet needs in chronic eye diseases.
© 2023 Glaukos Corporation Page 24
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