Vyluma, Inc.

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

BRIDGEWATER, N.J., May 29, 2024 (GLOBE NEWSWIRE) -- Vyluma, Inc. (“Vyluma”), a biopharmaceutical company dedicated to advancing novel ophthalmic solutions for refractive errors, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its lead compound, NVK002. The application is confirmed to be eligible for a Paediatric Use Marketing Authorisation (PUMA), providing 10 years of data exclusivity and marketing protection upon product approval. “This acceptance represents an important and key milestone for our Company, as NVK002 has now been submitted for regulatory review across our three most key global markets: the U.S., China, and the European Union,” stated Raul A. Trillo, MD, MBA, President, and Chief Commercial Officer of Vyluma. “Our steadfast commitment to delivering an innovative pharmaceutical option for pediatric myopia underscores our dedication to improving children’s vision worldwide.” The regulatory application of NVK002 is supported by previously reported safety and efficacy data from the multi-center, placebo-controlled, Phase III CHAMP (Childhood Atropine Myopia Progression) clinical study which evaluated the safety and efficacy of the product in children aged three years and older. About Pediatric Myopia Pediatric myopia can start as early as three to four years old and is progressive in the early years of life. It can affect quality of life and lead to serious eye conditions such as glaucoma, retinal detachment and maculopathy later in life. Myopia adversely impacts the vision of 30% of the world’s population today and is expected to impact an estimated 5 billion people by 2050.1,2 Currently, there are no FDA-approved, nor EMA-approved pharmaceutical treatments for myopia available in the U.S. or the E.U. 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. Investor Contact for Vyluma Investor Contact:Raul A. Trillo, MD, MBAPresident & Chief Commercial Officerrtrillo@vyluma.com References: Holden, B. A., Fricke, T. R., Wilson, D. A., Jong, M., Naidoo, K. S., Sankaridurg, P., Wong, T. Y., Naduvilath, T. J., & Resnikoff, S. (2016). Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology, 123(5), 1036–1042.Sankaridurg, P., Tahhan, N., Kandel, H., Naduvilath, T., Zou, H., Frick, K. D., Marmamula, S., Friedman, D. S., Lamoureux, E., Keeffe, J., Walline, J. J., Fricke, T. R., Kovai, V., & Resnikoff, S. (2021). IMI Impact of Myopia. Investigative Ophthalmology & Visual Science, 62(5).