Glaucoma 1, Open Angle, A

Glaucoma is leading cause of irreversible blindness worldwide, projected to affect 112 million people by 2040 SAN DIEGO, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Amydis Inc., a privately held clinical-stage company pioneering a platform of ocular tracers to enable imaging of disease biomarkers in the eye, today announced it has launched a Phase 2 clinical program for its novel retinal tracer, AMDX-2011P, to detect amyloid-beta in glaucoma patients. Glaucoma is an age-related neurodegenerative disease associated with the loss of retinal ganglion cells and characteristic vision loss. It is the leading cause of irreversible blindness worldwide, projected to affect 112 million people by 2040. The rate of glaucoma progression can vary across patients; and diagnosis, defining prognosis, establishing progression, and developing optimal interventions can be challenging. Multiple diagnostic tests detect structural and vascular changes in the retina associated with glaucoma while visual function tests can evaluate visual loss associated with the disease. However, the relationship between and time of onset of these structural, vascular and visual function changes are not well established. The addition of another in-vivo diagnostic modality such as detection of molecular changes would add significant clarity to the pathogenesis of the disease. Converging data indicate that amyloid beta, best known for its association with Alzheimer’s disease, is a key factor in glaucoma pathogenesis. The extensive links between Alzheimer’s disease and glaucoma have prompted the notion that glaucoma is an “ocular Alzheimer’s disease”. The Amydis patented retinal tracer, AMDX-2011P, is a small molecule designed to enable detection and quantification of amyloid beta deposits in the retina using imaging devices already incorporated as part of a patient’s standard office visit. Thus, as a widely adoptable, simple and accessible technology, the Amydis test will greatly increase the capture rate of glaucoma while improving clinical management through earlier intervention and, potentially, facilitation of amyloid beta targeted neuroprotective therapies. In collaboration with the University of California-San Diego (UCSD), Amydis completed critical proof-of-concept studies demonstrating the Amydis tracers detect amyloid beta in post-mortem human eyes of glaucoma patients, but not healthy subjects. The results have been submitted for publication. “We are thrilled to launch a new clinical program for an eye disease. Enabling micron-level in-vivo tracking of retinal amyloid beta formation in glaucoma patients will add a gain-of-function test to current loss-of-function testing, empowering doctors to deliver better patient care,” said Dr. Stella Sarraf, Amydis founder and chief executive officer. “Our goal is to also facilitate the development of neuroprotective agents to help provide more therapeutics for patients.” Amydis has launched a Phase 2 open label, blinded endpoint assessment study of AMDX-2011P as a retinal tracer in subjects with primary open angle glaucoma. This trial is being conducted at three sites in Southern California to collect multi-modal retinal imaging data on 40 subjects. This multi-modal data will include optical coherence tomography (OCT) and OCT Angiography (OCT-A), enabling Amydis to map retinal amyloid beta, retinal structure (OCT), and retinal vascular (OCT-A) signatures and monitor their relative changes to better understand the pathophysiology of glaucoma. “If successful, the creation of a molecular endpoint with the Amydis technology has the potential to enhance standard of care for glaucoma patients by enabling improved diagnostic and prognostic evaluation, as well as being used as an endpoint to develop neuroprotective therapies,” said Dr. Robert N. Weinreb, Chair of the Amydis Scientific Advisory Board, Chair and Distinguished Professor of Ophthalmology at UCSD and Director of Shiley Eye Institute. About Amydis, Inc. Amydis is developing novel, patent-protected molecules, “ocular tracers”, which enable direct visualization of central nervous system disease-related molecular changes (biomarkers) in the eye. With this first-in-class capability, Amydis is poised to revolutionize the ability of physicians and researchers to explore the eye for a broad spectrum of diseases, which have to date required long-term clinical evaluation and the use of invasive testing for definitive diagnosis. The company has a discovery platform and proprietary know-how that position it as first mover and a global leader in developing ocular tracers for human diseases. The future of effective, sustainable healthcare depends on knowledge gained through early diagnostics. Contact: info@amydis.com

The ViaLase Laser combines the precision of femtosecond laser technology and the accuracy of micron-level image guidance to deliver the world's first femtosecond laser image-guided high-precision trabeculotomy (FLigHT) ALISA VIEJO, Calif., Oct. 30, 2023 /PRNewswire/ -- ViaLase, Inc., a clinical-stage medical technology company focused on addressing unmet needs in the conventional glaucoma treatment paradigm, today announced it has completed enrollment of VIA-002, the company's pivotal trial of the ViaLase® Laser to treat adult patients with primary open angle glaucoma (POAG). The ViaLase Laser combines the precision of femtosecond laser technology and the accuracy of micron-level image guidance to deliver a noninvasive glaucoma treatment called femtosecond laser image-guided high-precision trabeculotomy, or FLigHT. "We are delighted to have our pivotal trial fully enrolled with a total of 152 patients," said Tibor Juhasz, PhD, Founder and Chief Executive Officer, ViaLase, Inc. "There is a significant unmet need for a noninvasive, nonpharmacological treatment for glaucoma patients who are not ready for cataract surgery or who have already had cataract surgery and are struggling on medical therapy. We are optimistic that our pivotal trial will demonstrate the safety and efficacy of the first-ever FLigHT treatment performed by the ViaLase Laser. Ultimately, it is our greatest wish to be able to provide an effective noninvasive treatment to the millions of people living with glaucoma, one of the leading causes of irreversible blindness worldwide." "VIA-002 is a non-inferiority efficacy study comparing the ViaLase Laser to selective laser trabeculoplasty (SLT)," said Richard Lewis, MD, Chief Medical Officer, ViaLase, Inc. "We are hopeful the results of this trial will be consistent with our first-in-human study, which published data of patients followed out to 24 months. ViaLase believes our technology will give doctors the opportunity to intervene earlier in the treatment paradigm with a potentially safe and effective noninvasive procedure." VIA-002 is a prospective, randomized, controlled, multi-center trial of the use of the ViaLase Laser versus SLT in adult patients with POAG. In the study, 152 subjects were randomized to either the ViaLase Laser or SLT. The primary effectiveness endpoint is a reduction in mean unmedicated intraocular pressure (IOP) from baseline to 6 months and 12 months. Secondary effectiveness endpoints are the percentage of eyes with a >20% reduction in unmedicated IOP at 6 months and 12 months with no secondary surgical intervention to treat glaucoma, and a reduction in mean number of hypotensive medications from screening to 6 months and 12 months. About the ViaLase Laser The ViaLase Laser combines a femtosecond laser and micron-level, high-definition image guidance to deliver a noninvasive glaucoma treatment called femtosecond laser image-guided, high-precision trabeculotomy, or FLigHT. The ability to noninvasively create a conduit between Schlemm's canal and the anterior chamber is an advantage unique to the FLigHT procedure. This first-of-its-kind technology addresses an unmet need for a noninvasive procedure for patients who would benefit from a non-pharmacological, non-surgical procedure but whose therapeutic goals do not justify the risks of a surgically invasive procedure such as minimally invasive glaucoma surgery (MIGS) or traditional filtration surgery. About Glaucoma Glaucoma affects 76 million people worldwide, a number that is expected to increase to 112 million by 2040, and is the second leading cause of irreversible blindness in the world.1,2 Most forms of glaucoma are chronic and, when left undetected or untreated, lead to irreversible vision loss. Early detection and treatment are essential to protecting against vision loss, which results when the optic nerve deteriorates, leading to progressive loss of the field of vision. Lowering IOP and thus reducing visual field progression is the only proven glaucoma treatment today. The current treatment paradigm typically begins with topical eye drops, then may advance to laser therapy or minimally invasive glaucoma surgery (MIGS), before resorting to invasive, traditional filtration surgery. About ViaLase, Inc. ViaLase, Inc. is a globally-minded, venture capital-backed, clinical-stage medical technology company located in Aliso Viejo, CA. ViaLase is focused on disrupting the conventional glaucoma treatment paradigm with the introduction of a truly noninvasive image-guided femtosecond laser treatment that enhances glaucoma patient care. With a leadership team that has vast experience developing, designing, manufacturing, and commercializing the first femtosecond lasers for ophthalmic surgery for refractive and cataract patients, ViaLase is now bringing that expertise and innovation to glaucoma patients. ViaLase believes in collaborating closely with health care providers, payers, societies, and patients to inform our product development and commercial activities with the goal of bringing this revolutionary treatment to glaucoma patients across the globe. For more information, visit . References World Health Organization. World report on vision: Executive Summary 2019. Tham YC, Xiang L, et al. Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040: A Systematic Review and Meta-Analysis. Ophthalmology 2014; 121(11): 2081-2090. Any product/brand names and/or logos are trademarks of ViaLase, Inc. MEDIA CONTACT: Michele Gray Gray Communications, LLC. (917) 449-9250 [email protected] SOURCE ViaLase, Inc.

IYUZEH™ (latanoprost ophthalmic solution) 0.005%, the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), is now available in the U.S. WALTHAM, Mass., Sept. 26, 2023 /PRNewswire/ -- Thea Pharma Inc. ("Thea"), the U.S. subsidiary of Europe's leading independent ophthalmic-focused pharmaceutical company, Théa, dedicated to the research, development, and commercialization of ophthalmic products, today announced the launch and availability of IYUZEH™ (latanoprost ophthalmic solution) 0.005% in the U.S. market. Preservative-free latanoprost, launched over ten years ago, is available in 46 countries, mostly under the brand name MONOPROST®, with about 1.5 million patients treated monthly.1 IYUZEH is the first and only preservative-free latanoprost for patients with primary open-angle glaucoma (POAG) and ocular hypertension (OHT) in the U.S. In randomized, controlled clinical trials of patients with POAG or OHT with mean baseline intraocular pressure (IOP) of 19-24 mmHg, IYUZEH lowered IOP by 3–8 mmHg compared to 4–8 mmHg by XALATAN®.2-4 Experience the full interactive Multichannel News Release here: "The U.S. launch of IYUZEH is a major step forward for Théa Group, the eye care community, and patients," said Jean-Frédéric Chibret, President of Théa. "Glaucoma is a chronic eye disease that affects the everyday lives of more than 60 million people globally. With IYUZEH now available, eye care providers can effectively treat their POAG and OHT patients with preservative-free latanoprost. I would like to thank everyone involved in achieving this milestone – including the providers and patients who participated in the clinical studies, our teams, and each of our partners – for helping us deliver on our commitment to enable patients access to medication without preservatives." "With the launch of IYUZEH in the U.S., Thea is responding to an important unmet need in the treatment landscape. IYUZEH brings similar efficacy of traditional latanoprost, formulated without preservatives, to help eye care providers confidently address their treatment goals of lowering intraocular pressure for people with POAG and OHT," said Susan Benton, President of Thea Pharma Inc. "We are thrilled to introduce IYUZEH and provide clinicians with an important new treatment option for their patients." "With the availability and proven efficacy of IYUZEH, it is now possible for eye care providers to lower elevated intraocular pressure in patients with POAG or OHT without preservatives on the ocular surface," said Jason Bacharach, M.D., Founder and Director of Research at North Bay Eye Associates in Petaluma, California. "This is a powerful option for our patients and for us, as treating clinicians." IYUZEH is available now through authorized distributors and the following wholesalers and order numbers: ABC (10282592), ANDA (603442), Cardinal (5865035), McKesson (2849651), NDC (82584-003-30). From enrollment to dispensing, Thea is committed to supporting eye care professionals and patients in every step of the access process. IYUZEH (latanoprost ophthalmic solution) 0.005% is now available for as little as $60 for a 30-day supply through programs with PhilRx® and the Thea Savings Card. For more information and eligibility requirements, please visit iyuzeh.com. PhilRx is a service that provides a convenient way to prescribe IYUZEH, with the medication shipped for free and directly to a patient's door. This service offers online and phone support for both eye care professionals and their patients. The Thea Savings Card is available to those commercially insured and not enrolled in a state or federally funded program. A patient may check their eligibility and activate this savings card at activatethecard.com/theasavingscard. Whether a physical or digital card, it can be utilized or redeemed at any retail pharmacy in the U.S. Thea is committed to helping patients have access to IYUZEH. A Patient Assistance Program is available for eligible U.S. patients that have a demonstrated financial need and are without prescription insurance coverage. With this program, we aim to allow every qualified patient the chance to see their treatment with eyes wide open. About IYUZEH™ IYUZEH™ (latanoprost ophthalmic solution) 0.005%, an opalescent, white to slightly yellow ophthalmic solution, is a topical formulation of latanoprost that is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). IYUZEH™ does not contain a preservative – it is the first and only preservative-free formulation of latanoprost, the most prescribed prostaglandin F2α analogue (PGA), in the United States. The recommended dosage of IYUZEH™ is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. IOP reduction is present for at least 24 hours. In the two clinical trials conducted with IYUZEH™ (latanoprost ophthalmic solution) 0.005%, the most frequently reported ocular adverse reactions were conjunctival hyperemia (34%) and eye irritation (19%) compared to XALATAN®, the preserved 0.005% latanoprost reference product which reported conjunctival hyperemia (37%) and eye irritation (31%). Healthcare providers, patients, and caregivers can learn more about IYUZEH at iyuzeh.com. INDICATIONS AND USAGE IYUZEH is a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Known hypersensitivity to latanoprost or any other ingredients in this product. WARNINGS AND PRECAUTIONS Pigmentation: Topical latanoprost ophthalmic products, including IYUZEH™ have been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with IYUZEH™ can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes: Latanoprost ophthalmic products, including IYUZEH™ may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment. Intraocular Inflammation: IYUZEH™ should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation because inflammation may be exacerbated. Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost ophthalmic products, including IYUZEH™. IYUZEH™ should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Herpetic Keratitis: Reactivation of herpes simplex keratitis has been reported during treatment with latanoprost. IYUZEH™ should be used with caution in patients with a history of herpetic keratitis. IYUZEH™ should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated. Contact Lens Use: Contact lenses should be removed prior to the administration of IYUZEH™ and may be reinserted 15 minutes after administration. ADVERSE REACTIONS The following adverse reactions have been reported with the use of topical latanoprost products: iris pigmentation changes, eyelid skin darkening, eyelash changes (increased length, thickness, pigmentation, and number of lashes), intraocular inflammation (iritis/uveitis), and macular edema, including cystoid macular edema. DRUG INTERACTIONS The combined use of two or more prostaglandins, or prostaglandin analogs including IYUZEH™ is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. For more information about IYUZEH™, please visit iyuzeh.com. For Full Prescribing Information, please visit . About Primary Open-angle Glaucoma The American Glaucoma Society states that glaucoma is a common ophthalmic disorder characterized by typical optic nerve damage and vision loss. It is most associated with elevated or dysregulated intraocular pressure, although there is evidence that other factors contribute to the disease.5 Glaucoma is a leading cause of irreversible blindness worldwide. Its prevalence in the U.S. is approximately 1,900 per 100,000 persons over age forty, and the condition is responsible for upwards of nine million clinic visits each year.6-8 In the U.S., where annual spending on optic nerve disorders is estimated at $5.8 billion annually,9 glaucoma is a significant public health concern. About Ocular Hypertension Mean IOP slowly rises with increasing age. Age older than 40 years is considered a risk factor for the development of OHT and POAG.10 OHT, a common condition, is a leading risk factor for the development of OAG.11 OHT is defined as IOP consistently greater than 21 mmHg (in at least one eye) and the absence of clinical signs of glaucoma.12 The risk of developing glaucoma increases with increasing IOP.13 Population studies such as the Framingham, Beaver Dam, Baltimore, Rotterdam, Barbados, and Egna-Neumarkt studies estimate that 4-10% of the population older than 40 years will have IOP levels of 21 mmHg or higher without detectable signs of glaucomatous damage. OHT has a 10-15 times greater prevalence than POAG.14 The use of topical IOP-lowering medications reduced the risk of glaucoma development from 9.5% in the control group to 4.4% in the intervention group.15 About Théa Laboratoires Théa is an independent pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, it has thirty-five affiliates & offices in Europe, North and South America, North Africa, and the Middle East. Today, its network includes nearly 1,900 employees, and its products are available in 75 countries around the world. In 2022, Théa had global revenues of approximately $941 million. The independent and family-owned and run group, founded from a Research and Development start-up by Henri Chibret, has been chaired since 2008 by Jean-Frédéric Chibret, his nephew. To learn more about Théa Group, visit . About Thea Pharma, Inc. Thea Pharma, Inc., is the United States subsidiary of Théa. Its product offering is comprised of a portfolio of seven leading eye-care products that are regulated or approved by the U.S. Food and Drug Administration (FDA), including Zioptan®, AcellFX™, Cosopt®, Cosopt® PF, Azasite®, Akten®, and Betimol®, iVIZIA™ dry-eye drops and eyelid hygiene products, and now IYUZEH™. By focusing our passion and expertise within the U.S. market, Thea Pharma's goal is to deliver uncompromising care that allows all stakeholders to envision the future of ophthalmic treatment with eyes wide open. To learn more about Thea Pharma, Inc., visit . References: Théa. Data on file. 2023. IYUZEH™ (latanoprost ophthalmic solution) 0.005%. Prescribing information. Thea Pharma Inc; 2022. Bacharach J, Ahmed IIK, Sharpe ED, Korenfeld MS, Zhang S, Baudouin C. Preservative-Free versus Benzalkonium Chloride–Preserved Latanoprost Ophthalmic Solution in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3 US Clinical Trial. Clin Ophthalmol. 2023;17:2575-2588. . Rouland JF, Traverso CE, Stalmans I, et al. Efficacy and safety of preservative-free latanoprost eyedrops, compared with BAK-preserved latanoprost in patients with ocular hypertension or glaucoma. Br J Ophthalmol. 2013;97(2):196–200. doi:10.1136/bjophthalmol-2012-302121. The American Glaucoma Society (AGS). Unmet needs in the detection, diagnosis, monitoring, treatment, and understanding of primary open angle glaucoma. 2021; 11. . Accessed March 1, 2023. Friedman DS, Wolfs RC, O'Colmain BJ, et al. Prevalence of open-angle glaucoma among adults in the United States. Arch Ophthalmol. 2004;122(4):532–538. doi:10.1001/archopht.122.4.532. Schappert SM. Office Visits for Glaucoma: United States, 1991-92. Vital and Health Statistics, Centers for Disease Control and Prevention / National Center for Health Statistics. 1995; March, No. 262. Lee PP, Walt JG, Doyle JJ, et al. A multicenter, retrospective pilot study of resource use and costs associated with severity of disease in glaucoma. Arch Ophthalmol. 2006;124(1):12–19. doi:10.1001/archopht.124.1.12. Wittenborn JS, Zhang X, Feagan CW, et al. The economic burden of vision loss and eye disorders among the United States population younger than 40 years. Ophthalmology. 2013;120(9):1728–35. . Leske MC, Connell AM, Wu SY, et al. Distribution of intraocular pressure. The Barbados Eye Study. Arch Ophthalmol. 1997 Aug. 115(8):1051-7. Kass MA, Heuer DK, Higginbotham EJ, et al. Assessment of Cumulative Incidence and Severity of Primary Open-Angle Glaucoma Among Participants in the Ocular Hypertension Treatment Study After 20 Years of Follow-up. JAMA Ophthalmol. 2021;139(5):558–566. doi:10.1001/jamaophthalmol.2021.0341. Burr JM, Botello-Pinzon P, Takwoingi Y, Hernandez R, Vazquez-Montes M, Elders A, et al. Surveillance for ocular hypertension: an evidence synthesis and economic evaluation. Health Technol Assess. 2012;16(29):1-271, iii-iv. Burr JM, Mowatt G, Hernandez R, Siddiqui MAR, Cook J, Lourenco T, et al. The clinical effectiveness and cost-effectiveness of screening for open angle glaucoma: a systematic review and economic evaluation. Health Technol Assess. 2007;11(41):iii-iv, ix-x, 1-190. Chihara E. Assessment of true intraocular pressure: the gap between theory and practical data. Surv Ophthalmol. 2008 May-Jun. 53(3):203-18. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: A Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-Angle Glaucoma. Arch Ophthalmol. 2002;120(6):701-713. doi:10.1001/archopht.120.6.701. PRC-IYZ-1676-v2 SOURCE Thea Pharma Inc.