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
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.
“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.
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.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231214281849/en/
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
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