Low Tension Glaucoma

A first-in-class product, QLS‑111 is designed to lower intraocular pressure (IOP) beyond currently achievable levels in patients with glaucoma by targeting episcleral venous pressure (EVP) DEDHAM, Mass.--(BUSINESS WIRE)-- Qlaris Bio, Inc. (“Qlaris”), a clinical-stage biotechnology company targeting unmet needs in debilitating ophthalmic diseases, today announced the initiation and dosing of two separate U.S. Phase II masked, randomized clinical trials investigating QLS‑111 in patients with ocular hypertension and glaucoma. “The start of these Phase II trials represents a key milestone in our goal of bringing QLS‑111 to glaucoma patients for whom consistent IOP lowering and control has been an unachievable goal,” said Thurein Htoo, Chief Executive Officer. “IOP remains the only modifiable risk factor for the treatment of glaucoma, and additional treatments are needed for patients. QLS‑111 has the potential to change the treatment paradigm by effectively reducing IOP by lowering EVP, an unaddressed component of IOP.” Qlaris is initiating the following studies: The Osprey study (NCT06016972) will assess the safety, tolerability, and optimal dose of QLS‑111 compared with vehicle alone in adult patients who have primary open-angle glaucoma (POAG) and/or ocular hypertension (OHT). The efficacy of QLS-111 in lowering IOP will be assessed as a secondary endpoint of the trial. The Apteryx study (NCT06249152) will evaluate the safety and tolerability, and measure the additive IOP-lowering efficacy, of QLS‑111 in combination with latanoprost versus latanoprost alone. Patients aged 12 years or older and who have open-angle glaucoma (OAG) and/or OHT currently on latanoprost will be enrolled in the trial. “We are very pleased to initiate these studies in support of QLS-111 clinical development,” said Barbara Wirostko, MD, FARVO, Chief Medical Officer. “Despite the number of therapies currently available to clinicians, there remains a critical unmet need for new drugs that target unique parameters within IOP regulation with a strong safety profile. With a novel mechanism of action that targets EVP, as well as early data demonstrating it may be used in combination with existing treatments, QLS‑111 has the potential to make a significant impact.” QLS‑111 is an ATP-sensitive potassium channel modulator that is designed to reduce IOP by reducing EVP and distal outflow resistance, making it potentially suitable for treating POAG, OHT, and normal tension glaucoma (NTG). Current medications fall into two categories, those that reduce aqueous humor production and those that target proximal outflow. However, none of the current medications directly address distal outflow and EVP. This is important as EVP contributes up to 50% of total IOP, often leaving patients unable to reach IOP reduction goals to slow their disease progression, despite currently available therapies. QLS‑111's complementary mechanism may offer a significant and synergistic advantage in managing IOP. “I’m very excited about the promise of QLS‑111, which in healthy, normotensive volunteers lowered pressure significantly from baseline,” said Shan Lin, MD, Co-Research Director at the Glaucoma Center of San Francisco — a QLS‑111 investigational site — and a member of the Qlaris Scientific Advisory Board. “This suggests that QLS‑111 will benefit patients who do not adequately respond to currently available drugs due to the IOP floor set by EVP. Importantly, this compound has demonstrated that it can work alone or in combination with several current glaucoma drug classes, indicating that its use with current medications will aid in the ability to achieve levels of IOP reduction that slow disease progression. With its strong safety pro no clinically meaningful hyperemia, QLS‑111 holds enormous promise for our patients.” About QLS‑111 QLS‑111 is a novel topical formulation using Qlaris Bio’s ATP-sensitive potassium channel modulator platform originally developed by Dr. Michael Fautsch, PhD, professor of ophthalmology, biochemistry, and molecular biology at Mayo Clinic, in Rochester, Minnesota. QLS-111 lowers IOP by relaxing vessels of the vascular and vascular-like tissues distal to the trabecular meshwork, thereby reducing distal outflow resistance and lowering EVP. Though multiple mechanisms of action exist to lower IOP in patients with glaucoma, these agents target only three of the four components of IOP as described by the Goldman equation for IOP: the aqueous humor inflow rate, the uveoscleral outflow rate, and the conventional outflow facility. There are currently no approved drugs that selectively target the reduction of EVP. This leaves a significant gap in the potential to maximally lower IOP, since EVP can be the largest determinant of overall IOP. Studies have demonstrated that treatment with QLS‑111 provides persistent lowering of IOP, maintains normal vascular integrity of the venous system, is well-tolerated, and thus far has shown it does not cause hyperemia. About Qlaris Bio, Inc. Qlaris Bio, Inc. was founded in August 2019 with a singular focus: to develop novel, innovative therapies with first-in-class mechanisms of action to address serious and debilitating ophthalmic diseases. The company’s lead program, QLS‑111, uses ATP-sensitive potassium channel modulators that improve outflow through distal vascular tissues of the eye to reduce IOP. Qlaris Bio’s investors include Canaan and New Leaf Venture Partners, both of which were co-lead investors in the company’s $25 million Series A funding round in August 2019. Other investors include Correlation Ventures and Mayo Clinic, where the science behind QLS‑111 originated. For more information, please visit .

Optica Foundation Challenge provides grants for work on early-stage intervention in menopause and glaucoma Optica Foundation funds research to detect menopause and glaucoma more cost-effectively and efficiently Chip-integrated light sensor to uncover hormonal biomarkers of menopause Light-based system to detect undetectable glaucoma WASHINGTON, Dec. 4, 2023 /PRNewswire/ -- The Optica Foundation today released more detailed information on new women's health and vision research funded by the 2023 Optica Foundation Challenge. Researchers Samantha Grist, The University of British Columbia, Canada, and Fernando Zvietcovich, Pontificia Universidad Catolica del Peru, Peru, have proposed two separate light-based techniques to solve for challenges in diagnosing health-related concerns, specifically menopause and glaucoma. Continue Reading "As healthcare diagnostics advance, new opportunities for non-invasive, light-based techniques continue to emerge," said Alan Willner, chair of the Challenge Selection Committee. "Excitedly, both Dr. Grist and Dr. Zvietcovich are exploring novel, innovative ways of using light to address issues found in current modalities—precisely the kind of exemplary work the Optica Foundation Challenge strives to address." New opportunities for non-invasive, light-based techniques continue to emerge, -Alan Willner, chair, Selection Committee Post this Each research effort is supported by a USD$100,000 grant from the Optica Foundation, and Grist and Zvietcovich will use these funds to advance their research in the following ways: Light-based sensor to identify menopause markers Samantha Grist, The University of British Columbia, Canada Silicon photonic biosensors for low-cost, portable, data-rich measurements of hormone biomarkers relevant to women's health and the menopausal transition Research Executive Summary According to the World Health Organization, the average onset of menopause is between 45 and 55, and the World Bank reports women aged 50 to 54 now make up 6% of the total female population. Yet, despite the potential prevalence of menopause and its precursor perimenopause, physicians have limited tools and data to understand and predict symptoms or improve treatment.That's partly because today's diagnostics include centralized lab-based assays that are expensive, slow, and inconvenient for daily testing, and point-of-need solutions do not provide the required quantitative accurate data from the multiple hormone markers needed to understand symptoms, improve treatment, and predict the onset of menopause. However, new work from Samantha Grist, The University of British Columbia, Canada, offers promise in the form of a silicon photonic integrated circuit (PIC) with biosensors.Grist's silicon PIC approach introduces the potential for quantitative, accurate, data-rich measurements of hormones, with tens to hundreds of biosensors integrated on a single millimeter-scale chip in the future. However, PIC-based biosensor analysis has required costly and bulky systems that limit their applicability in clinical environments—until now. Grist and her team have invented a new sensor architecture that addresses this challenge by applying a tiny, inexpensive laser for readout."Our work focuses on validating a portable, low-cost technology for decentralized, multiplexed monitoring of hormone markers in urine," explained Grist. "We will build a tool that has the potential to drastically improve health and quality of life during the menopausal transition."Grist points to a two-fold approach to advance this concept: 1. A rigorous exploration of the new sensor architecture to quantify and optimize its performance; and 2. Assay design to appropriately evaluate hormone biomarkers. In six months, Grist hopes to be at the stage to start actively measuring hormone markers and evaluating the full scope of the application with an interdisciplinary team."I didn't realize there was such a profound lack of diagnostic and treatment options for perimenopause and menopause until I met with Herstasis Health, a Canadian nonprofit dedicated to addressing this issue," explained Grist. "Now, I'm really motivated to help people experiencing menopause diagnose and predict its stages and address its symptoms. This grant gives me the chance to do meaningful work and demonstrate how photonic innovation can address unmet needs." Detecting undetectable glaucoma Fernando Zvietcovich, Pontificia Universidad Catolica del Peru, Peru Development of a clinical multi-excitation optical coherence elastography system to interrogate corneal biomechanics for the detection and staging of normotensive glaucoma Research Executive Summary Globally, glaucoma is a leading cause of vision impairment and blindness, with 7.7 million people impacted by the disease. Unfortunately, more than half of cases are undiagnosed.In part, that can be attributable to current diagnostic standards, which require the monitoring of corneal pressure. The issue is that in normotensive glaucoma (NTG), corneal pressure levels remain in the normal range, making early detection and intervention difficult, if not impossible. In addition, corneas with softer biomechanics and high astigmatism may also lead to inaccurate pressure readings.To address these concerns, Fernando Zvietcovich, Pontificia Universidad Catolica del Peru, Peru, has proposed the development of a clinical multi-excitation optical coherence elastography system. This system will enable high-resolution structural images of the eye through optical coherence tomography (OCT). At the same time, the system will leverage air and ultrasonic pulses to excite the mechanical waves in the cornea, providing biomechanical information of the eye to help obtain corrected and adjusted intraocular pressure values, thus enabling the detection of NTG."This field of applying OCT with other imaging modalities and excitation sources is really just emerging," Zvietcovich shared. "We're measuring properties in the human eye and changes in biomechanics that were not possible to measure before, and we have entered a new dimension with the information that we can now see. We're in the early stages of new ways to monitor and propose treatments for the eye."As a first step, Zvietcovich plans to finalize designs and build a prototype optical coherence elastography system. Once it's created, he will initiate modeling tests to refine the approach, and ultimately, will take the system into clinical settings. In six months, Zvietcovich expects to have the first expression of the prototype, and ultimately, he plans to hold a preliminary patient study with 20 control patients, 20 patients with NTG, and 20 patients with high-tension glaucoma to generate biomechanically inspired biomarkers of the cornea."In the short term, the main benefit of this work will be that it enables researchers to apply these technologies and clinical studies will follow. In the long term, I can see this device in clinics, helping diagnose NTG and other eye diseases more efficiently and cost-effectively. Ultimately, I hope that patients will avoid vision loss because of this research," Zvietcovich summed up. Both research initiatives were made possible by grants awarded through the Optica Foundation Challenge. This challenge was designed to engage early-career professionals in out-of-the-box thinking and provide seed money to investigate hypotheses in the areas of environment, health and information. Each of the recipients received USD$100,000 to explore their ideas and take steps toward addressing critical global issues. Recipients have begun work on these projects and expect to report initial results later in 2024. For more information, visit optica.org/challenge. About Optica Optica (formerly OSA), Advancing Optics and Photonics Worldwide, is the society dedicated to promoting the generation, application, archiving and dissemination of knowledge in the field. Founded in 1916, it is the leading organization for scientists, engineers, business professionals, students and others interested in the science of light. Optica's renowned publications, meetings, online resources and in-person activities fuel discoveries, shape real-life applications and accelerate scientific, technical and educational achievement. Discover more at: Optica.org About Optica Foundation Optica Foundation donors believe that by attracting, supporting and retaining the most capable young scientists and engineers in optics, we can drive breakthroughs that shape our future. By investing in student and early-career professionals and fostering their interest, we ensure the continued advancement of our field. For over 20 years, the Optica Foundation has been dedicated to this endeavor. optica.org/foundation SOURCE Optica Foundation

Galimedix eligible for upfront payment plus various success-based milestone payments and royalties on future net salesEquity investment by Théa Open Innovation into Galimedix supports further Galimedix pipeline development In parallel, Galimedix will continue to extend its pipeline, particularly in Alzheimer’s disease CLERMONT FERRAND, France and KENSINGTON, Md., March 29, 2023 (GLOBE NEWSWIRE) -- Théa Open Innovation (“TOI”), a sister company of ophthalmic specialty pharmaceutical company Laboratoires Théa, and Galimedix Therapeutics, Inc. (“Galimedix”), a clinical-stage biotechnology company addressing the cause of neurodegenerative diseases of the eye and central nervous system, announced today that they have signed a licensing agreement. Galimedix will grant TOI exclusive rights for the development and commercialization of GAL-101, Galimedix’s lead disease-modifying compound, for the topical and oral treatment of dry age-related macular degeneration (AMD), glaucoma and other ophthalmic indications with high unmet medical need, in Europe, the Americas, the Middle East and Africa. Under the terms of the agreement, Galimedix will receive an upfront technology access fee and is eligible to receive further success-based milestone payments as well as royalties on net sales. While TOI will fully fund the remaining development of GAL-101 in dry AMD and take charge of the registration and commercialization of the drug, Galimedix will remain responsible for the mid-stage clinical trials, leveraging their respective expertise and familiarity with the compound, which has a unique first-to-market mechanism of action. Furthermore, TOI will invest into Galimedix, thereby demonstrating its strong interest in the Galimedix pipeline, including in Alzheimer’s disease (AD). “Through the partnership with Galimedix, Thea will be among the few companies globally that are working on an innovative drug for the treatment of dry AMD patients who are currently at risk of going blind,” said Jean-Frédéric Chibret, President of the Théa Group. “We are excited to be working with Galimedix, as this collaboration supports our continued commitment to building a strong cutting-edge and diversified ophthalmological portfolio for eye care specialists around the world and their patients.” GAL-101: Eye drops and tablets – the first drug candidate for disease-modification of dry AMD is also designed to be patient friendlyGAL-101 is Galimedix’s most advanced compound, ready to enter clinical Phase 2/3 trials. Delivered topically as an eye drop, it is expected to provide a convenient and safe treatment for two of the leading causes of blindness – dry AMD and glaucoma, including normo-tension glaucoma, an indication not addressed by any of the approved glaucoma drugs. GAL-101 was designed to target β-amyloid (Aβ) aggregates, the underlying cause of distinct neurodegenerative diseases of the eye and the central nervous system (CNS). Preclinically, GAL-101 demonstrated compelling efficacy, protecting neuronal retinal cells from toxic damage in relevant ophthalmic models. In clinical Phase 1 testing, Galimedix has successfully demonstrated GAL-101’s excellent safety and tolerability profile. Also, the company has received supportive FDA feedback to continue the development through Phase 2 or Phase 2/3. The first patient is planned to be enrolled in 2024, with initial clinical efficacy results expected about 18 months later. Based on convincing results in animals, it is also planned to develop GAL-101 as an oral formulation to offer another convenient treatment alternative to patients. “We are excited to partner our front-runner program, GAL-101, in ophthalmology with TOI, a company highly respected in and fully dedicated to the challenging field of ophthalmology already for several generations. This collaboration is an important milestone for Galimedix, as it further validates our technology and is critical to bringing GAL-101 through clinical development and approval to help patients who are currently at risk of gradually going blind,” said Alexander Gebauer, MD, Executive Chairman of Galimedix Therapeutics, Inc. “In addition, we are gratified by the strong support TOI has shown towards Galimedix by way of its equity investment in the company. This will enable us to move forward with our development plans for GAL-201, our next-generation oral compound for Alzheimer’s disease.” Age-related macular degeneration (AMD) – leading cause of adult blindnessAMD is a neurodegenerative disease of the retina and is classified as either “wet” or “dry”. Dry AMD is the most common form of the condition. In dry AMD, toxic Aβ aggregates cause retinal cells in the central area (the macula) to slowly degenerate and die. The result is progressive loss of vision. Currently, there is no approved treatment for dry AMD. AMD affects about one in four adults over the age of 65. It is estimated that there are currently around 200 million patients globally suffering from AMD, which is the leading cause of adult blindness in the U.S. and other industrialized countries. Additional information About β-amyloid (Aβ) aggregation and GAL-101β-amyloid (Aβ) aggregations occur when Aβ monomers are misfolded. These aberrant structures form toxic Aβ oligomers and protofibrils, and finally insoluble Aβ aggregates which are deposited. Comprehensive scientific evidence has shown that Aβ aggregations can be highly toxic to retinal cells and brain neurons and are likely to play an important role in the progressive loss of neurons. Striking similarities link the underlying neurodegenerative pathology in ocular neurodegenerative diseases, such as glaucoma and age-related macular degeneration (AMD), with the central nervous system disorder, Alzheimer’s disease (AD). This suggests that elimination of toxic Aβ oligomers and protofibrils could be a promising therapeutic approach to slowing or halting retinal neurodegeneration. GAL-101 is designed to bind to a specific motif from Aβ, which is only exposed in the misfolded form of the Aβ monomer and can, therefore, be targeted. This ultimately leads to the elimination of all toxic species of Aβ from the retina while leaving normal Aβ intact and could potentially slow, halt or even reverse neurodegeneration and progression in AMD and glaucoma. About Galimedix Therapeutics, Inc.Galimedix Therapeutics, Inc. was founded by bio-entrepreneur Dr. Andrew Pearlman, neuroscientist Prof. Hermann Russ, Dr. Alexander Gebauer and others based on technology invented by Prof. Ehud Gazit and licensed from Tel Aviv University, Israel. Galimedix is a clinical-stage biotechnology company focused on developing innovative small molecule medicines addressing the cause of Alzheimer's disease, glaucoma, dry AMD, and other neurodegenerative disorders. The Company’s pipeline includes the pre-clinical candidate GAL-201 for the treatment of patients with Alzheimer’s disease and GAL-101 for patients with glaucoma and dry AMD. GAL-101 is about to enter Phase 2/3 clinical development. Galimedix is a U.S. Delaware corporation with operations in Europe, Israel, and the U.S. The company’s neuropharma team has extensive experience in successful industrial drug development. They and their global network of collaborators are among the world leaders in the field of Aβ toxicity and Aβ aggregation modulation. Galimedix’s success was facilitated by seed funding from InFocus Capital Partners and Rimonci Capital, two VC investors highly specialized in vision science technologies. About Théa and Théa Open InnovationThéa is the leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, this family-owned company has continued to expand by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, the Middle East. Its products are available in 75 countries. Théa Open Innovation (TOI) is a sister company of Théa. TOI's mission is to set up partnerships with companies and universities to help bring the most innovative products in ophthalmology to the market. Contact Colin FrancouAlexander GebauerThéa Open InnovationGalimedix Therapeutics, Inc.Managing director Executive Chairmancolin.francou@theaopeninnovation.com agebauer@galimedix.com For media enquiries: Anne Hennecke / Lydia Robinson-Garcia MC Services AG galimedix@mc-services.eu Tel.: +49-(0) 211-529252101