Corneal Endothelial Cell Loss

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.

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 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.

SAN DIEGO--(BUSINESS WIRE)-- Trefoil Therapeutics, a clinical-stage biotechnology company focused on restoring sight to people with corneal diseases, today announced multiple presentations providing evidence for clinical and preclinical efficacy of the company’s investigational medicine TTHX1114 for improving visual outcomes and protection against corneal endothelial damage at the Annual Association for Research in Vision and Ophthalmology (ARVO) Meeting in New Orleans, April 23-27, 2023. “We aim to address an unmet clinical need with TTHX1114 by offering the potential to restore vision by stimulating and protecting the cornea’s own endothelial cells,” said David Eveleth, Ph.D., President and CEO of Trefoil Therapeutics. “We're excited to share the growing body of research that supports TTHX1114 as an important and unique approach to corneal disease.” The details of the presentations are as follows (all times local, CT): Protection of endothelial cells by TTHX1114 in patients with Fuchs endothelial corneal dystrophy (FECD) undergoing Descemet’s Stripping Only (DSO) in combination with cataract surgery: evidence from the STORM study Presenter: David Eveleth Location: Room 244 Date and Time: Monday, April 24, 2023; 11:30-11:45 am The engineered fibroblast growth factor TTHX1114 mediates enrichment of proliferative and wound healing pathways in wounded human corneal endothelium Poster Number: 618 - B0255 Date and Time: Sunday, April 23, 2023; 12:00-1:45 pm Factors Affecting Recovery Following Descemet Stripping Only (DSO) with TTHX1114 Poster Number: 631 - B0268 Date and Time: Sunday, April 23, 2023; 12:00-1:45 pm TTHX1114 Protects Primary Rabbit Corneal Endothelial Cells from Oxidative Stress Poster Number: 621 - B0258 Date and Time: Sunday, April 23, 2023; 12:00-1:45 pm David Eveleth will be a panelist in a symposium titled “Emerging Therapeutics to Maintain Corneal Health” on April 25, 2023, from 8:45-10:30 am in the La Nouvelle C room. His topic will be: The Role of Fibroblast Growth Factor derivatives in corneal endothelial regeneration which will be presented from 9:13-9:27 am. Trefoil will also be present at booth #1156. About TTHX1114 TTHX1114 is an investigational engineered variant of the naturally occurring molecule Fibroblast Growth Factor-1 (FGF1), which stimulates cell proliferation and migration as well as protecting cells from stress and injury. Trefoil is conducting clinical trials for TTHX1114 as an intracameral injection into the eye for patients susceptible to corneal edema due to endothelial damage, including Fuchs Endothelial Corneal Dystrophy (FECD) and other corneal endothelial dystrophies (CED) and patients with other risk factors undergoing ocular surgeries. The drug is aimed at protecting and regenerating corneal endothelial cells lost due to disease and thereby improving vision. The topical formulation of TTHX1114 is designed to accelerate corneal ulcer wound healing by stimulating epithelial cell growth, potentially reducing common complications associated with corneal ulcers, such as pain, inflammation, and loss of vision due to corneal scarring. The Phase 1 safety study for the topical product was completed in March of 2023. About Trefoil Therapeutics San Diego-based Trefoil Therapeutics is a clinical-stage biotechnology company focused on leveraging its engineered FGF1 protein technology platform to develop first-in-class pharmacologic treatments for serious corneal endothelial diseases and epithelial disorders. Trefoil’s lead product candidate is TTHX1114, an investigational engineered form of naturally occurring FGF1 designed to stimulate corneal cell protection, proliferation and migration, thereby reversing vision loss. The technology underlying Trefoil’s platform was developed by co-founders Michael Blaber, Ph.D., and David Eveleth, Ph.D., and is licensed from Florida State University. Trefoil investors include Bios Partners, Hatteras Venture Partners, Access Biotechnology, Solasta Ventures, InFocus Capital Partners, Correlation Ventures, ExSight Ventures and FemHealth Ventures. Learn more at . Safe Harbor Statement The clinical research discussed in this press release is preliminary and the outcome of such studies may not be predictive of the outcome of later clinical trials. Future clinical trial results may not demonstrate safety and efficacy sufficient to obtain regulatory approval related to the clinical research findings discussed in this press release.