Atropine Sulfate

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

Boehringer's first-of-its-kind program automatically reduces the costs of its COPD and asthma inhalers at the pharmacy counter for vast majority of eligible patients Program provides predictable, affordable and consistent costs for as many patients as possible, including uninsured patients and those with high co-pays RIDGEFIELD, Conn., June 1, 2024 /PRNewswire/ -- Boehringer Ingelheim's new program to cap out-of-pocket costs at $35 per month for eligible patientsi for the company's inhalers is now available. With this program, patients who have had difficulty navigating the current healthcare system will now be able to afford the Boehringer inhalers they need. "Ensuring equitable access to life-saving medications is not just a commitment—it's our responsibility," said Jean-Michel Boers, President and CEO, Boehringer Ingelheim USA Corporation. "This program and its $35 cost to patients applies to our entire portfolio of inhalers, making them affordable to all eligible patients, including the most vulnerable patients, such as those who are uninsured or underinsured. While we recognize this is just one solution, we see it as a stepping-stone in our ongoing commitment to ensure the healthcare system is fairer and simpler for all patients." Starting today, the reduced out-of-pocket cost will be automatically applied at participating retail pharmacies for eligible patients with commercial insurance. More than 90% of pharmacies across the country are participating in the program, making the change seamless and automatic for most patients. There are no forms to fill out or websites to go to—the discount happens electronically with no action required. All other eligible patients, including those whose pharmacies do not participate and those without insurance, can visit to enroll for a savings card to present at pharmacies to receive the same $35 cap of out-of-pocket costs. The program applies to all Boehringer Ingelheim inhalers, including: Atrovent® HFA (ipratropium bromide HFA) Inhalation Aerosol Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray Spiriva® HandiHaler® (tiotropium bromide inhalation powder) Spiriva® Respimat® 1.25 mcg (tiotropium bromide) Inhalation Spray Spiriva® Respimat® 2.5 mcg (tiotropium bromide) Inhalation Spray Stiolto® Respimat® (tiotropium bromide and olodaterol) Inhalation Spray Striverdi® Respimat® (olodaterol) Inhalation Spray The program builds on Boehringer's long-standing commitment to supporting patients. The company provides savings cards for most of its products, which help patients meet the co-payments required by their insurance companies. In addition, the company provides medicine for free to eligible patients through the Boehringer Cares Foundation. About Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at . iTerms and conditions apply. Government restrictions exclude people enrolled in federal government insurance programs from co-pay support. ATROVENT HFA (ipratropium bromide HFA) INHALATION AEROSOL Indication for Use ATROVENT HFA (ipratropium bromide HFA) Inhalation Aerosol is a prescription maintenance treatment for bronchospasm (airway narrowing) in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. Important Safety Information Do not use ATROVENT HFA if you are allergic to ipratropium or any of the ingredients in ATROVENT HFA or to atropine or similar drugs. ATROVENT HFA is not a rescue medicine and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking ATROVENT HFA at once and call your doctor or get emergency help. ATROVENT HFA may increase eye pressure which may cause or worsen some types of glaucoma. Do not get the spray into your eyes. The spray may cause eye pain or discomfort, blurred vision, enlarged pupils, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. Dizziness and blurred vision may occur with ATROVENT HFA. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or machinery. ATROVENT HFA may cause difficulty with urination. Symptoms may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking ATROVENT HFA and call your doctor right away. The most common side effects reported with use of ATROVENT HFA were bronchitis, COPD flare-up (exacerbation), shortness of breath and headache. Tell your doctor about all medicines you are taking, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with ATROVENT HFA can increase side effects. Please see full Prescribing Information including Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1‑800‑FDA‑1088. (9/16) CL-AT-0017 Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray Indication for Use COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator. Important Safety Information Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs. COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms. Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma. If you have sudden vision changes, eye pain or visual halos, stop taking COMBIVENT RESPIMAT and call your doctor right away. COMBIVENT RESPIMAT may cause difficulty with urination. Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines. Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual. Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help. Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), thyroid disorder, or diabetes. Also tell your doctor if you are pregnant or nursing. Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression. The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath. Click here for full Prescribing Information and Patient Instructions for Use. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. CL-CBR-100003 10.31.2018 SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray and SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) Indications SPIRIVA RESPIMAT, 2.5 mcg, and SPIRIVA HANDIHALER are long-term, once-daily, prescription maintenance medicines used to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis and emphysema. SPIRIVA RESPIMAT and SPIRIVA HANDIHALER also reduce the likelihood of flare-ups (COPD exacerbations). SPIRIVA RESPIMAT, 1.25 mcg, is a long-term, once-daily, prescription maintenance treatment of asthma for people 6 years and older. SPIRIVA is not a treatment for sudden symptoms of asthma or COPD. Important Safety Information for SPIRIVA RESPIMAT Do not use SPIRIVA RESPIMAT or SPIRIVA HANDIHALER if you are allergic to tiotropium, ipratropium, atropine or similar drugs, or any ingredient in these medicines. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER are not rescue medicines and should not be used for treating sudden breathing problems. Your doctor may give you other medicine to use for sudden breathing problems. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause allergic reactions. Symptoms can include raised red patches on your skin (hives), itching, rash and/or swelling of the lips, tongue, or throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking the medicine and seek emergency medical care. Before using SPIRIVA HANDIHALER, tell your doctor if you have a severe allergy to milk proteins. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause your breathing to suddenly get worse (bronchospasm). If this happens, use your rescue inhaler, stop taking SPIRIVA, and call your doctor right away or seek emergency medical care. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can increase the pressure in your eyes (acute narrow-angle glaucoma) which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking your medicine and call your doctor right away. Dizziness and blurred vision may occur with SPIRIVA RESPIMAT or SPIRIVA HANDIHALER. If you experience these symptoms, use caution when engaging in activities such as driving a car, or operating appliances or machinery. SPIRIVA RESPIMAT or SPIRIVA HANDIHALER can cause new or worsened urinary retention. Symptoms of blockage in your bladder and/or enlarged prostate may include difficulty passing urine and/or painful urination. If you have any of these symptoms, stop taking your medicine and call your doctor right away. The most common side effects reported with SPIRIVA RESPIMAT in patients with COPD include sore throat, cough, dry mouth, and sinus infection. The most common side effects with SPIRIVA RESPIMAT in adult patients with asthma were sore throat, headache, bronchitis, and sinus infection. The side effect profile for adolescent and pediatric patients was comparable to that observed in adult patients with asthma. The most common side effects reported with SPIRIVA HANDIHALER in patients with COPD include upper respiratory tract infection, dry mouth, sinus infection, sore throat, non-specific chest pain, urinary tract infection, indigestion, runny nose, constipation, increased heart rate, and blurred vision. Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through your mouth using the HANDIHALER device. Do not spray SPIRIVA RESPIMAT into your eyes, as this may cause blurring of vision and pupil dilation. Tell your doctor about all your medical conditions including kidney problems, glaucoma, enlarged prostate, problems passing urine, or blockage in your bladder. Tell your doctor all the medicines you take, including eye drops. Ask your doctor if you are taking any anticholinergic medicines because taking them together with SPIRIVA can increase side effects. Do not use SPIRIVA RESPIMAT and SPIRIVA HANDIHALER together. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA RESPIMAT. Click here for full Prescribing Information and Patient Instructions for Use for SPIRIVA HANDIHALER. CL-SVR-0048 2.15.2017 STIOLTO RESPIMAT (tiotropium bromide and olodaterol) Inhalation Spray APPROVED USE FOR STIOLTO RESPIMAT STIOLTO® RESPIMAT® (tiotropium bromide and olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STIOLTO is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. STIOLTO is not for asthma. Important Safety Information for STIOLTO RESPIMAT Do not use STIOLTO if you have asthma. People with asthma who take long-acting beta2-agonist (LABA) medicines, such as olodaterol, (one of the medicines in STIOLTO), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Do not use STIOLTO if you are allergic to tiotropium, ipratropium, atropine or similar drugs, olodaterol, or any ingredient in STIOLTO. Call your healthcare provider or get emergency medical care if you experience symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. Get emergency medical care if your breathing problems worsen quickly or if you use your rescue inhaler but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STIOLTO. Do not use STIOLTO more often than prescribed by your doctor. Do not use STIOLTO with other LABAs or anticholinergics. Do not use STIOLTO for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all your medical conditions including heart problems, high blood pressure, seizures, thyroid problems, diabetes, kidney problems, glaucoma, enlarged prostate, and problems passing urine. STIOLTO can cause serious side effects, including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happens, stop taking STIOLTO and seek immediate medical help. STIOLTO can cause new or worsening eye problems including narrow-angle glaucoma, and can increase the pressure in your eyes, which can cause the following symptoms: eye pain, blurred vision, seeing halos or colored images along with red eyes. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. STIOLTO can cause new or worsened urinary retention. Symptoms of urinary retention may include difficulty passing urine, painful urination, urinating frequently, or urinating in a weak stream or drips. If you have any of these symptoms, stop taking STIOLTO and call your doctor right away. The most common side effects of STIOLTO are runny nose, cough, and back pain. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, eye drops, vitamins, and herbal supplements. STIOLTO and certain other medicines may affect each other. STIOLTO is for oral inhalation only. The STIOLTO cartridge is only intended for use with the STIOLTO RESPIMAT inhaler. Do not spray STIOLTO into your eyes. Your vision may become blurred and your pupils may become larger (dilated). You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Read the step-by-step patient Instructions for Use for STIOLTO RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, Patient Information, and Instructions for Use for STIOLTO RESPIMAT. CL-STO-100022 6.5.2019 STRIVERDI® RESPIMAT® (olodaterol) Inhalation Spray APPROVED USE for STRIVERDI RESPIMAT Striverdi® Respimat® (olodaterol) Inhalation Spray is a prescription medicine used long term, 2 puffs, 1 time each day, in controlling symptoms in adults with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. STRIVERDI RESPIMAT is not for treating sudden symptoms of COPD. Always have a rescue medicine with you to treat sudden symptoms. Striverdi is not for asthma. Important Safety Information for STRIVERDI RESPIMAT Do not use STRIVERDI if you have asthma. People with asthma who take long‐acting beta2‐agonist (LABA) medicines, such as STRIVERDI RESPIMAT, without also using a medicine called an inhaled corticosteroid (ICS), have an increased risk of serious problems from asthma, including being hospitalized, needing a tube placed in their airway to help them breathe, or death. Get emergency medical care if your breathing problems worsen quickly or you use your rescue medicine but it does not relieve your breathing problems. Call your healthcare provider if breathing problems worsen over time while using STRIVERDI. Do not use STRIVERDI RESPIMAT more often than prescribed for you by your doctor. Do not use STRIVERDI RESPIMAT with other LABAs. Do not use STRIVERDI for treating sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms. Tell your doctor about all of your medical conditions, including heart problems, high blood pressure, seizures, thyroid problems, and diabetes. STRIVERDI RESPIMAT can cause serious side effects including sudden shortness of breath that may be life threatening, fast or irregular heartbeat, increased blood pressure, chest pain, tremor, headache, nervousness, high blood sugar, or low blood potassium that may cause muscle weakness or abnormal heart rhythm. If any of these happen, stop taking STRIVERDI and seek immediate medical help. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction including: rash, hives, itching, swelling of the face, lips, tongue, throat, and difficulties in breathing or swallowing. The most common side effects are runny nose, sore throat, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and joint pain. Tell your doctor about all the medicines you take, including prescription and non‐prescription medicines, vitamins, and herbal supplements. STRIVERDI and certain other medicines may affect each other. STRIVERDI is for oral inhalation only. The STRIVERDI cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. Do not spray STRIVERDI into your eyes. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1 ‐ 800 ‐ FDA ‐ 1088. Read the step-by-step patient Instructions for Use for STRIVERDI RESPIMAT before you use your inhaler. Please see accompanying full Prescribing Information, including Patient Information, and Instructions for Use for STRIVERDI RESPIMAT. CL-STRR-100001 6.5.2019 Media Contact Michele Baer Human Pharma Communications [email protected] Boehringer Ingelheim 900 Ridgebury Road Ridgefield CT 06877 More information boehringer-ingelheim.com/us ISC-MPR-US 103150 - 05/24 SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.