Investor Presentation
May 2024
Disclaimer
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 March 31, 2024, which was filed with the SEC on May 3, 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 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.
© 2024 Glaukos Corporation 2
The iDose® TR Journey
Nearly two decades of investment and commitment
134K
15+
YEARS
of research and development to bring iDose TR from ideation to commercialization
$600+
MILLION
invested in R&D
since 2018 to
advance iDose TR
and other
innovations,
representing 30%+
of revenues
1150
SUBJECTS
studied in Phase 3
FDA iDose TR
clinical trials that
met both CDRH
and CDER
requirements
SQ FEET
build-out of
iDose TR
manufacturing
facilities that meet
appropriate
regulatory, CMC and
ISO 7 guidelines
100K+
PAGES
in NDA
submission to
CDRH and CDER for FDA approval of iDose TR
© 2024 Glaukos Corporation 3
iDose TR is FDA-approved
Our pioneering journey is just beginning
Revolutionary, micro-invasive, injectable treatment for the full range of glaucoma disease severity
First-everlong-duration procedural pharmaceutical designed to deliver up to 3 years of glaucoma drug therapy
© 2024 Glaukos Corporation 4
iDose TR: Groundbreaking Glaucoma Advancement
INDICATIONS AND USAGE
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)
<0.5mm
1.8mm
Unique Drug Formulation
75 mcg of a novel, proprietary, preservative-freetravoprost 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
Insertion System | Fixed and Stable |
Precision-engineered to facilitate | Securely anchored into scleral |
straightforward implantation | tissue for drug elution directly |
into the anterior chamber |
© 2024 Glaukos Corporation 5
iDose TR: Addresses Important Clinical Needs
High rates of non-compliance and non-adherence to topical medications contribute to disease progression
Topical medications are the dominant treatment plan for the roughly 18M US eyes1 affected by glaucoma and ocular hypertension
Research2 shows that | & ~ 5 0 % |
> 9 0 % | |
of patients are non-compliant | purposely discontinue their |
with medication use | medication(s) within 6 months |
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 | © 2024 Glaukos Corporation 6 |
glaucoma therapy. Am J Ophthalmol. 2005;140(4): 598-606 | |
iDose TR: Phase 3 Data Validates Game-Changing Potential
IOP REDUCTIONS FROM BASELINE OBSERVED DURING FIRST 3 MONTHS1
iDose TR
Timolol 0.5% BID
Baseline (mmHg) | 8.5 | 8.4 | |
7.7 | |||
from | |||
IOP Reductions | 7.2 | ||
6.6 | 6.7 | 6.8 | |
6.5 | |||
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)
IOP VALUES ON PRE-STUDY PGAs, AFTER PGA WASHOUT AND AT 3 MONTHS OF iDOSE TR
24 | In-Study iDose | ||||
Pre-study | 23.8 | • 125 subjects across both Phase 3 trials | |||
22 | TR: | were on single PGA IOP-lowering med | |||
PGAs: | mmHg | -7.1 mmHg | |||
at screening | |||||
-5.8 mmHg | (Δ 1.3 mmHg | ||||
20 | vs pre-study | • After 4-week washout, IOP rose to 23.8 | |||
PGAs, | mmHg, showing pre-studyPGA | ||||
p = 0.0003) | |||||
18 | efficacy of -5.8 mmHg | ||||
(mmHg) | 18.0 | ||||
16.7 | • After iDose TR administration, IOP | ||||
IOP | 16 | mmHg | decreased to 16.7 mmHg at 3 months, | ||
mmHg | showing iDose TR in-study efficacy of | ||||
14 | -7.1 mmHg | ||||
12 | • iDose TR demonstrated 1.3 mmHg | ||||
statistically significant superior IOP- | |||||
lowering vs pre-study PGAs (p = | |||||
10 | Pre-Study PGA | After Washout (Remove | 0.0003) | ||
pre-study PGA) | Month 3 |
Statistically significant superior IOP-lowering vs pre-study PGAs in sub-group analysis of combined Phase 3 trials
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 | © 2024 Glaukos Corporation 7 |
iDose TR: Phase 3 & Phase 2b Data Confirms Long Duration
81% of iDose TR subjects in the Phase 3 trials were completely free of IOP-lowering topical medications at 12 months
- OF iDOSE TR SUBJECTS WELL-CONTROLLED1 ON THE SAME OR FEWER IOP-
LOWERING TOPICAL MEDICATIONS
AT 12 MONTHS | AT 24 MONTHS | AT 36 MONTHS | |
PH 3 | 93% | ||
PH 2B | 92% | 72% | 69% |
- PATIENTS WELL CONTROLLED1 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 ≤ 18 mmHg in the Phase 2B trial. In the Phase 3 trials, they were defined as those with | © 2024 Glaukos Corporation 8 |
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 | |
iDose TR: Pharmacokinetic Clinical Study Results
iDose TR shown to deliver therapeutically relevant and durabledrug concentrations through 24 months
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
MEAN TFA CONCENTRATIONS
5.0 | 3.7 | 5.6 | 3.8 | 3.3 |
ng/mL | 2.0 | 2.2 | ||
3 Months | 6 Months 12 Months 15 Months | 18 Months 21 Months | 24 Months |
AVG AMOUNT OF TRAVOPROST REMAINING FOLLOWING EXPLANTATION
TravoprostOf | 79% | 70% | 28% | |||
50% | 39% | 35% | ||||
16% | ||||||
% | ||||||
3 Months 6 Months 12 Months 15 Months | 18 Months 21 Months 24 Months |
Mean TFA levels were above CMAX 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
At 24 months, iDose TR implants still contained 16% of the travoprost drug product
Data abstract accepted for presentation at ARVO 2024 Annual Meeting | © 2024 Glaukos Corporation 9 |
iDose TR: Phase 3 & Phase 2b Results Show Excellent Safety
PHASE 3 AND PHASE 2B SAFETY DATA
Ph 3 Trials | Ph 2b Trial | Topical PGAs | |
1 Year | 3 Years | ||
No adverse events of | Up to 70% incidence |
periorbital fat atrophy | |
Very low conjunctival | 30%-50% incidence |
hyperemia | |
No adverse events of corneal | |
endothelial cell loss | |
Very low or no incidence of | ~20% incidence |
iris color change | |
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.
© 2024 Glaukos Corporation 10
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Glaukos Corporation published this content on 20 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 May 2024 11:22:04 UTC.