Vyluma, Inc.

10月23日，兆科眼科宣布NVK002（0.01%及0.02%的低剂量阿托品）为期两年的III期临床试验（“China CHAMP”）的顶线结果。 China CHAMP是一项随机、双盲、安慰剂平行对照、多中心、III期临床研究，其主要目标为评估NVK002对治疗中国儿童及青少年近视加深的疗效及安全性。该项试验涉及18间中心，入组777名患者。 经过两年的治疗，这项研究分析显示，NVK002滴眼液组（0.01%和0.02%剂量）对比安慰剂组在主要疗效指标上有统计学意义的显著性差异，NVK002滴眼液组优于安慰剂组，且具有剂量依赖。两种剂量的NVK002安全性良好，患者使用依从性好。 NVK002是一种用于控制儿童及青少年近视加深的试验性新型外用眼部溶液。NVK002不含防腐剂，预计保存期至少24个月。NVK002的临床开发涉及两款不同浓度的阿托品，以便配合个别患者的需要，灵活达致最佳疗效与最少副作用。 2020年10月，Nevakar授予兆科眼科在中国、韩国和东南亚地区开发和商业化NVK002的权益。Nevakar其后将协议转让予其全资附属公司Vyluma。 兆科眼科董事会主席、执行董事兼行政总裁李小羿博士（Dr. Benjamin Li）表示：“我们对NVK002之China CHAMP试验的强大疗效和安全性数据感到兴奋。兆科眼科继续处于有利地位，有望成为中国第二家取得近视眼药物监管批准的公司。我们希望尽快将该药物商业化并带给患者。” 今年3月，兴齐眼药0.01%硫酸阿托品滴眼液（SQ-729）获NMPA批准上市，用于延缓儿童近视进展，成为国内首款上市的延缓儿童近视进展低浓度硫酸阿托品滴眼液。 日前，兴齐眼药的0.02%和0.04%硫酸阿托品滴眼液用于延缓儿童近视进展的III期研究也传来捷报。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。 免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

Vyluma Discusses Response to FDA’s Questions and Clarifies Regulatory Pathway for its 505(b)(2) NDABRIDGEWATER, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a clinical stage pharmaceutical company is focused on the development of ophthalmic treatments for disease states with limited treatment options. On June 4, 2024, the Company had a Type A meeting with representatives of the U.S. Food and Drug Administration’s (FDA’s) Division of Ophthalmology to discuss the response to FDA’s questions regarding its late-stage product candidate, Atropine Sulfate Ophthalmic Solution 0.01% under development to treat pediatric myopia. Vyluma is very encouraged by the discussion with FDA and will move forward with a submission to address FDA’s questions in the third quarter of 2024. “I am very pleased with the discussion that took place at the meeting with FDA, and we have a pathway forward to respond to FDA’s Complete Response Letter,” stated George Zorich, Chairman and CEO of Vyluma. “We believe that Atropine Sulfate Ophthalmic Solution 0.01% will make a profound difference for children who are diagnosed with myopia to prevent or reduce further progression.” “We are very excited about the results of the CHAMP study,” said Karla Zadnik, OD, PhD, Glenn A. Fry Professor in Optometry and Physiological Optics at The Ohio State University and the CHAMP study principal investigator. Dr. Zadnik stated that, “Myopia leads to a higher risk for serious eye conditions to develop eventually, and the higher the level of myopia, the higher the risk for serious eye diseases. Eye care practitioners’ efforts to treat myopia early on will be vital to decreasing the risk of long-term negative outcomes.” The CHAMP Study The CHAMP study was a multinational study that enrolled 576 children with myopia, was conducted partly during COVID, and demonstrated efficacy for Atropine Sulfate Ophthalmic Solution, 0.01% that is consistent with the benefits reported in the published literature. The CHAMP study demonstrated a consistent benefit of Atropine Sulfate Ophthalmic Solution, 0.01% in a responder analysis, change in spherical equivalent refraction (SER), change in axial length, and time to change in SER. When the 3 main pre-specified endpoints (responder, mean change in SER, mean change in AL) were assessed together, it was shown that the observed favorable benefit in all three endpoints is unlikely due to chance (p=0.004). What Is Pediatric Myopia? Myopia, or nearsightedness, is a common refractive anomaly that often begins between the ages of six and 14 years and progresses over several years before stabilizing and lasting through adulthood. With myopia, the eye’s axial length is longer than normal (from front to back), which causes light to focus in front of the retina instead of directly on it.1,2 Those with myopia have difficulty seeing distant objects, but near objects are clear. Myopia is a condition that may lead to higher risk of blindness and serious eye complications later in life. Myopia is the leading cause of preventable blindness worldwide.3 If current trends continue, it is estimated that by 2050 there will be approximately 5 billion people with myopia (50% of the world’s population).4 Higher levels of myopia significantly increase a child’s risk for serious blinding eye disease in their lifetime, such as myopic maculopathy, posterior staphyloma, retinal detachment, cataract, and glaucoma.5 Current Treatment Options Interventions to slow the progression of myopia include spectacles or contact lenses.5 Common treatments for myopia include various contact lens options, but safety remains a concern because the risk of sight-threatening microbial keratitis (bacterial infection of the cornea) and the possibility of regression after discontinuation of lens wear.4 Spectacles are another treatment option for children who are unable or prefer not to wear contact lenses. Given the impact myopia may have on an individual’s long-term health and that it is a widespread condition, additional interventions are needed to help mitigate the prevalence and severity of this condition. About Vyluma, Inc. Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat the progression of myopia in children aged 3 years and older. Vyluma has a robust pipeline of other assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For additional information please visit www.vyluma.com. About Nevakar Inc. Nevakar Inc. is a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the US 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at www.nevakar.com. References American Optometric Association. Myopia (Nearsightedness). Accessed 6/4/2021.American Academy of Ophthalmology. Myopia Control in Children. Accessed 6/4/2021.Wu W, Xie Y, Liu X, et al. Analysis of Scientific Collaboration Networks among Authors, Institutions, and Countries Studying Adolescent Myopia Prevention and Control: A Review Article.Iran J Public Health. 2019;48(4):621-631.Lawrenson JG, Dhakal R, Verkicharla PK, Shah R, Huntjens B, Downie LE, Kernohan A, Li T, Virgili G, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta‐ Cochrane Database of Systematic Reviews 2021, Issue 4. Art. No.: CD014758. DOI: 10.1002/14651858.CD014758.Noel A. Brennan, Youssef M. Toubouti, Xu Cheng, Mark A. Bullimore. Efficacy in myopia control, Progress in Retinal and Eye Research. 2020;100923. Media Contact: Houman Hemmati, MD, PhDChief Medical Affairs Officerhhemmati@vyluma.com

BRIDGEWATER, N.J., June 18, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a clinical stage pharmaceutical company is focused on the development of ophthalmic treatments for disease states with limited treatment options. On June 4, 2024, the Company had a Type A meeting with representatives of the U.S. Food and Drug Administration’s (FDA’s) Division of Ophthalmology to discuss the response to FDA’s questions regarding its late-stage product candidate, Atropine Sulfate Ophthalmic Solution 0.01% under development to treat pediatric myopia. Vyluma is very encouraged by the discussion with FDA and will move forward with a submission to address FDA’s questions in the third quarter of 2024. “I am very pleased with the discussion that took place at the meeting with FDA, and we have a pathway forward to respond to FDA’s Complete Response Letter,” stated George Zorich, Chairman and CEO of Vyluma. “We believe that Atropine Sulfate Ophthalmic Solution 0.01% will make a profound difference for children who are diagnosed with myopia to prevent or reduce further progression.” “We are very excited about the results of the CHAMP study,” said Karla Zadnik, OD, PhD, Glenn A. Fry Professor in Optometry and Physiological Optics at The Ohio State University and the CHAMP study principal investigator. Dr. Zadnik stated that, “Myopia leads to a higher risk for serious eye conditions to develop eventually, and the higher the level of myopia, the higher the risk for serious eye diseases. Eye care practitioners’ efforts to treat myopia early on will be vital to decreasing the risk of long-term negative outcomes.” The CHAMPStudy The CHAMP study was a multinational study that enrolled 576 children with myopia, was conducted partly during COVID, and demonstrated efficacy for Atropine Sulfate Ophthalmic Solution, 0.01% that is consistent with the benefits reported in the published literature. The CHAMP study demonstrated a consistent benefit of Atropine Sulfate Ophthalmic Solution, 0.01% in a responder analysis, change in spherical equivalent refraction (SER), change in axial length, and time to change in SER. When the 3 main pre-specified endpoints (responder, mean change in SER, mean change in AL) were assessed together, it was shown that the observed favorable benefit in all three endpoints is unlikely due to chance (p=0.004). What Is Pediatric Myopia? Myopia, or nearsightedness, is a common refractive anomaly that often begins between the ages of six and 14 years and progresses over several years before stabilizing and lasting through adulthood. With myopia, the eye’s axial length is longer than normal (from front to back), which causes light to focus in front of the retina instead of directly on it.1,2 Those with myopia have difficulty seeing distant objects, but near objects are clear. Myopia is a condition that may lead to higher risk of blindness and serious eye complications later in life. Myopia is the leading cause of preventable blindness worldwide.3 If current trends continue, it is estimated that by 2050 there will be approximately 5 billion people with myopia (50% of the world’s population).4 Higher levels of myopia significantly increase a child’s risk for serious blinding eye disease in their lifetime, such as myopic maculopathy, posterior staphyloma, retinal detachment, cataract, and glaucoma.5 CurrentTreatment Options Interventions to slow the progression of myopia include spectacles or contact lenses.5 Common treatments for myopia include various contact lens options, but safety remains a concern because the risk of sight-threatening microbial keratitis (bacterial infection of the cornea) and the possibility of regression after discontinuation of lens wear.4 Spectacles are another treatment option for children who are unable or prefer not to wear contact lenses. Given the impact myopia may have on an individual’s long-term health and that it is a widespread condition, additional interventions are needed to help mitigate the prevalence and severity of this condition. About Vyluma, Inc. Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma’s pipeline of therapies is led by NVK002, an investigational, preservative-free, low-dose atropine eye drop to treat the progression of myopia in children aged 3 years and older. Vyluma has a robust pipeline of other assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma itself is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are engaged in developing products for the ophthalmic and injectable markets. For additional information please visit . About Nevakar Inc. Nevakar Inc. is a fully integrated privately held, late-stage biopharmaceutical company with an extensive portfolio of products in the ophthalmic and injectable areas. Founded in 2015, and headquartered in Bridgewater, New Jersey, the Company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patients’ quality of life and healthcare outcomes. Nevakar utilizes the US 505(b)(2) regulatory pathway, along with its proven expertise in the development of novel and proprietary sterile pharmaceutical products to identify, develop, and obtain regulatory approval for its products. Additional information is available at . References American Optometric Association. Myopia (Nearsightedness). Accessed 6/4/2021. American Academy of Ophthalmology. MyopiaControlinChildren. Accessed 6/4/2021. Wu W, Xie Y, Liu X, et al. Analysis of Scientific Collaboration Networks among Authors, Institutions, and Countries Studying Adolescent Myopia Prevention and Control: A Review Article.Iran J Public Health. 2019;48(4):621-631. Lawrenson JG, Dhakal R, Verkicharla PK, Shah R, Huntjens B, Downie LE, Kernohan A, Li T, Virgili G, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta‐ Cochrane Database of Systematic Reviews 2021, Issue 4. Art. No.: CD014758. DOI: 10.1002/14651858.CD014758. Noel A. Brennan, Youssef M. Toubouti, Xu Cheng, Mark A. Bullimore. Efficacy in myopia control, Progress in Retinal and Eye Research. 2020;100923. Media Contact: Houman Hemmati, MD, PhD Chief Medical Affairs Officer hhemmati@vyluma.com