Amendment Adds Presbyopia as a New Investigational Application for Patented, Non-Invasive, Topical Eyelid Drug Delivery Platform
Presbyopia Expands Upon Already Established Investigational Applications for Dry Eye Disease, Glaucoma and Other Corneal Disorders
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 that it has entered into an amended licensing agreement with Intratus, Inc. under which Intratus has granted Glaukos a global exclusive license to research, develop, manufacture and commercialize Intratus’ patented, non-invasive drug delivery platform (the Eyelid Drug Delivery Platform) for application in the treatment of presbyopia.
The addition of presbyopia expands upon the existing agreement between the two parties announced on July 22, 2019, under which Glaukos secured a global exclusive license to research, develop, manufacture and commercialize the Eyelid Drug Delivery Platform for use in the treatment of dry eye disease, glaucoma and other corneal disorders, such as allergy, blepharitis, conjunctivitis and related conditions. Additionally, the amendment includes a mechanism to further expand the existing agreement to other indications, applying the active pharmaceutical ingredients being advanced by Glaukos in glaucoma, corneal disorders and presbyopia to new ophthalmic fields.
“We are excited to expand our partnership with Intratus by adding presbyopia as a new investigational application for this novel drug delivery platform and build upon the promising R&D work we’ve completed thus far in dry eye disease, glaucoma and other corneal disorders,” said Thomas Burns, Glaukos president and chief executive officer. “The Eyelid Drug Delivery Platform uses a differentiated, non-invasive, patient-friendly, transdermal approach and is highly complementary to our expanding portfolio of sustained pharmaceutical platforms in glaucoma, corneal health and retinal disease.”
“Intratus is pleased to have our platform technology continue its expansion through a second license with Glaukos,” said Aaron Dyer, Intratus president and chief executive officer. “We look forward to the progress Glaukos will continue to make and ultimately the restoration of sight we hope to provide for patients.”
Presbyopia is a natural part of aging due to the hardening of the eye’s crystalline lens over time, resulting in a loss of lens elasticity or the ability of the lens to change shape in order to focus incoming light on the retina. With this loss of flexibility, eyes are less able to adjust properly to focus on near objects. Presbyopia usually becomes noticeable around the age of 40 and there is no proven way to stop or reverse the progression of presbyopia.
The Eyelid Drug Delivery Platform’s patented cream-based drug formulations are applied to the outer surface of the eyelid for transdermal delivery of pharmaceutically active compounds for the treatment of eye disorders. Early human studies with this novel delivery system have demonstrated efficacy without the side effects often associated with drugs delivered as topical eye drops.
Under the expanded agreement, Glaukos will obtain an exclusive global license to Intratus’ drug delivery technology for use in the treatment of presbyopia, in addition to glaucoma and corneal disorders, including dry eye disease, allergy, blepharitis, conjunctivitis and related conditions. Financial terms of the agreement were not disclosed.
About Intratus, Inc.
Intratus, Inc. is a privately held, clinical-stage life sciences company dedicated to the development of its patented, novel, non-invasive drug delivery platform technologies focused on the treatment of ophthalmic diseases. Intratus is headquartered in San Diego, California.
Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012, its next-generation iStent inject® device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.
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 continued efficacy and safety profile of our products, the extent to which we may obtain regulatory approval for the Eyelid Drug Delivery Platform therapies or other investigational products, our ability to successfully commercialize such products, and the continued efficacy and safety profile of our products when commercially marketed as compared to their pre-approval clinical trial results. 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 Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission on March 1, 2021. Our filings with the Securities and Exchange Commission 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.