Vigabatrin

Stelios Papadopolous, Ph.D., a pioneering leader in biotech, appointed to Board of Directors; two industry veterans joined management team as Ovid prepares to take OV329 into patient trials and move its first KCC2 direct activator into the clinic Topline results from Phase 1 study of OV329 expected in Q3 2025, which will include biomarkers that measure clinical effect and target engagement, safety, and tolerability OV350, Ovid’s first program in its KCC2 direct activator library, initiated a first-in-human study in Q1 2025 Cash, cash equivalents and marketable securities of $53.1 million as of December 31, 2024, are expected to support operations and development programs into the second half of 2026 NEW YORK, March 11, 2025 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today reported business updates and financial results for the fourth quarter and year ended December 31, 2024. “Ovid is at an exciting inflection point. Our pipeline programs are moving into the next stage of clinical development and I believe our team is the strongest that it has been since the founding of the Company,” said Dr. Jeremy Levin, D.Phil., MB BChir., Chairman and CEO of Ovid Therapeutics. “To support us in capturing the substantial potential therapeutic and financial value associated with OV329, our program for treatment-resistant epilepsies, and our portfolio of first-in-class KCC2 activators, Dr. Stelios Papadopoulos has joined our Board and two industry leaders, Dr. Manal Morsy and Victoria “Tori” Fort joined our management team. Stelios’s extensive industry expertise and strategic vision will be invaluable to Ovid through our next stage of growth. Manal and Tori will support our regulatory and investor strategy and engagement,” stated Levin. Business Strategy & Updates Ovid expects its cash runway to support operations and clinical development programs into the second half of 2026, during which time multiple pipeline and regulatory milestones are anticipated. These anticipated milestones include: results for OV329 biomarker and safety data (Q3 2025); initiation of a Phase 2a patient study for OV329 in drug resistant epilepsies (Q1 2026); results from a first-in-human safety and exploratory biomarker study with OV350, our first KCC2 direct activator (Q4 2025); and initiation of human trials for the first oral KCC2 direct activator, OV4071 (Q2 2026). In the event the Company is unable to raise capital or enter into partnerships or co-development opportunities as and when needed, it will be required to delay, reduce the scope of or prioritize various research and development activities. The Company will continue to manage its clinical development programs, operations and cash expenditures with fiscal discipline to support the potential achievement of key value-creating clinical milestones. Given the breadth and depth of its pipeline, and the broad therapeutic opportunity it may yield, Ovid will continue to explore partnerships and co-development opportunities for select programs and regions to accelerate development and offset costs. Additional pipeline updates follow below. Organizational Updates Ovid has strengthened its Board of Directors and leadership team with key appointments intended to support the Company’s pipeline, business development and financial strategies. These include: Appointed Stelios Papadopolous, Ph.D., to serve on Board of Directors. Dr. Papadopolous is a scientist, investor and entrepreneur who has played a pivotal role in shaping the biotechnology industry for the last 30 years through bridging scientific discovery with financial strategy. His leadership, deal-making creativity, and ability to catalyze growth will be instrumental to Ovid as it seeks to capture the full potential value of its pipeline programs. Dr. Papadopoulos has served in roles including: the Vice Chairman of Cowen & Co., LLC; a leader in investment banking at PaineWebber, Chairman of PaineWebber Development Corp., a subsidiary focusing on biotechnology; and Vice President in the Equity Research Department of Drexel Burnham Lambert, covering the biotechnology industry. Dr. Papadopolous will serve on the Audit and Compensation Committees of Ovid’s Board of Directors. Leadership appointments. In February 2025, Manal Morsy, M.D., Ph.D., MBA and Victoria Fort joined Ovid as Chief Regulatory Officer and Head of Corporate Affairs & Corporate Strategy, respectively. Dr. Morsy brings deep expertise from successful global regulatory strategies and submissions spanning three decades, including adult and pediatric development drug candidates at J&J, Merck, PTC, and Athersys. She is a trained scientist, clinician and geneticist whose work has been published in many leading scientific and medical journals. Ms. Fort joins Ovid from Frontier Medicines, where she led corporate strategy, guided the company’s transition to a clinical-stage organization and helped secure critical financing. Pipeline Strategy & Updates Ovid is advancing a differentiated pipeline of potential first-in-class and best-in-class small molecule medicines that are intended to bring hyperexcited neurons back to homeostasis. The Company seeks to become a leader in neurotherapeutics by addressing intractable brain disorders with significant unmet need. This includes treating conditions and symptoms that manifest from excessive neural excitation such as seizures and psychosis. Central to the Company’s strategy is identifying and developing differentiated mechanisms of action to interdict unaddressed biological targets in the central nervous system (CNS) that are fundamental to disease pathology. This strategy includes developing a potential best-in-class, next-generation GABA aminotransferase (GABA-AT) inhibitor; translating the direct activation of the potassium chloride co-transporter 2 (KCC2) for a broad range of neurological and psychiatric conditions; and pioneering Rho-associated coiled-coil containing protein kinase 2 (ROCK2) inhibition for neurovascular and neuro-inflammatory conditions. OV329 A next-generation GABA-AT inhibitor: Ovid is developing OV329 as a next-generation GABA-AT inhibitor for the potential treatment of drug-resistant epilepsies (DREs) in adult and pediatric patients. OV329 seeks to endogenously deliver optimal levels of GABA to reduce seizures and provide a preferable safety and tolerability profile relative to the first-generation, GABA-AT inhibitor, vigabatrin. Ovid’s preclinical characterization suggests that OV329 is 100-fold more potent than vigabatrin in animals, delivers synaptic and extra-synaptic inhibition, and has a lasting pharmacodynamic effect despite rapid tissue clearance. In animal models, OV329 has been shown to have a therapeutic index and does not appear to induce sedation at therapeutic doses, whereas vigabatrin has no therapeutic window. A therapeutic dose of vigabatrin has been shown by independent researchers, and by Ovid, to preferentially accumulate in the retina. Human safety & tolerability: Ovid is completing a Phase 1 single- ascending dose (SAD) and multiple ascending dose (MAD) study evaluating OV329’s safety, tolerability, pharmacokinetics (PK) and biomarkers that may serve as a measure of clinical effect and target engagement. In the cohorts completed to-date, there have been no serious adverse events and no adverse events reported have been associated with OV329. Topline biomarker & safety data expected Q3 2025: Ovid added a higher dose cohort to its Phase 1 study, to increase dosing opportunities for future Phase 2 programs. Topline results from this cohort is expected in Q3 2025, and will include findings regarding how OV329 performed in specific parameters of transcranial magnetic stimulation (TMS) and magnetic resonance spectroscopy (MRS). Collectively, Ovid believes TMS and MRS have the potential to detect GABAergic activity, target engagement and clinical effect. TMS is a proven protocol for focal non-invasive electrical cortical stimulation that can safely and non-invasively measure target engagement. TMS has been previously used to correlate anti-seizure activity with vigabatrin and other anti-seizure medications (“ASMs”). Ovid is utilizing a range of TMS parameters for OV329, which can measure cortical excitation, including GABA-ergic, GABA (A) and GABA (B) receptor activity1. MRS technology has been utilized with other ASMs, including vigabatrin, as a way to measure GABA levels in selected regions of the brain. Utilizing MRS, Ovid will be able to evaluate and quantify the change in GABA levels in the medial parietal lobe relative to an untreated baseline. Ocular safety profile: To evaluate OV329’s safety compared to vigabatrin, Ovid has conducted additional animal experiments to evaluate the risk of drug accumulating in the eye and causing retinal cell dysregulation. At the 2024 American Epilepsy Society meeting in December, Ovid presented the full results from an animal study, which demonstrated that OV329 did not accumulate in animal eyes, in contrast to vigabatrin, which was found to accumulate in less than 48 hours. OV329 was present in the brain and plasma of mice, then rapidly cleared the tissue and remained undetectable in the retina, eye, and brain. In contrast, vigabatrin was demonstrated to preferentially accumulate in the eye, retina and brain, which is consistent with previously published independent research. TMS is a proven protocol for focal non-invasive electrical cortical stimulation that can safely and non-invasively measure target engagement. TMS has been previously used to correlate anti-seizure activity with vigabatrin and other anti-seizure medications (“ASMs”). Ovid is utilizing a range of TMS parameters for OV329, which can measure cortical excitation, including GABA-ergic, GABA (A) and GABA (B) receptor activity1. MRS technology has been utilized with other ASMs, including vigabatrin, as a way to measure GABA levels in selected regions of the brain. Utilizing MRS, Ovid will be able to evaluate and quantify the change in GABA levels in the medial parietal lobe relative to an untreated baseline. OV350 and KCC2 library Initiated a Phase 1, first-in-human study for a KCC2 direct activator, OV350: In Q4 2024, Ovid successfully submitted a regulatory application for a Phase 1 trial of OV350 and initiated a first-in-human study for this class of molecule in Q1 2025. OV350 is the first of multiple anticipated programs from Ovid’s library of KCC2 direct activators. The Phase 1 trial intends to evaluate the safety, tolerability and pharmacokinetic parameters of an intravenous formulation of OV350 in healthy human volunteers. It will also include an exploratory biomarker using quantitative EEG. In preclinical and animal disease models, OV350 has demonstrated antipsychotic and anticonvulsant effects, indicating that it may have broad therapeutic utility. The initial indication intended for OV350, and the oral program to follow, is psychosis associated with neuronal-synuclein diseases (NSD), including Parkinson’s disease, and Lewy body dementia (LBD). These conditions have similar underlying biology, significant unmet need and an established regulatory pathway. KCC2 direct activator library. Ovid has made significant progress with its KCC2 direct activator library and is progressing four programs toward clinical development, which are expected to yield successive regulatory submissions annually for the next three to four years. These programs are unique structures with discreet pharmacology and differentiated therapeutic attributes as characterized in phenotypic and disease biology models. Ovid believes these molecules may have relevance across a range of conditions that have symptoms driven by neural hyperexcitability such as seizures and psychoses. Based upon the bioavailability and potency characteristics, Ovid believes different programs in the library have amenability for oral and intramuscular or subcutaneous formulations to address clinical indications across the care continuum. OV4071, the first oral KCC2 direct activator: Ovid has initiated IND-enabling studies of OV4071, the first oral direct activator of the biological target, KCC2. It anticipates initiating human studies with OV4071 in Q2 2026, with both healthy volunteer and patient cohorts. This oral program behaves similarly to OV350 in phenotypic and disease model screens and is similarly intended for the potential treatment of psychoses in NSD and LBD. OV888/GV101 & ROCK2 inhibitor programs OV888/GV101 Capsule for CCM: In the third quarter of 2024, Ovid and Graviton Bioscience announced the decision to pause the initiation of the Phase 2 proof-of-concept study of OV888/ GV101 capsule, following the recent completion of long-duration competitor and academic trials in CCM, and after discussions with key stakeholders. Ovid and Graviton Bioscience are evaluating clinical design learnings and regulatory feedback from recently completed competitor Phase 2 programs. Ovid and Graviton Bioscience are confident of the potential therapeutic effects of ROCK2 inhibition for CCM and will seek to optimize future development approaches with the benefit of further insights on study duration, enrichment strategies, endpoints, and time-to-event measurements. Fourth Quarter and Annual 2024 Financial Results Cash, cash equivalents and marketable securities as of December 31, 2024 totaled $53.1 million. Revenues from royalty agreements were $566,000 for the year ended December 31, 2024, as compared to $392,000 for the same period in 2023. Research and development expenses were $5.9 million and $36.8 million for the three months and full year ended December 31, 2024, compared to $10.6 million and $28.6 million for the same periods in 2023. The overall increase is related to the advancement of Ovid’s clinical and preclinical pipeline programs as described above. The decrease between the three-month periods is the result of the organizational restructuring in the second quarter of 2024, which re-prioritized development programs. General and administrative expenses were $4.9 million and $25.7 million for the three months and full year ended December 31, 2024, as compared to $7.7 million and $31.1 million for the same periods in 2023. The decrease was driven by the previous organizational restructuring and related cost-reduction efforts. Total operating expenses were $10.8 million and $62.5 million for the three months and full year ended December 31, 2024, as compared to $18.3 million and $59.7 million for the same periods in 2023. Ovid reported a net loss of $9.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.13 for the three months ended December 31, 2024, as compared to a net loss of $15.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.21 for the same period in 2023. Ovid reported a net loss of $26.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.37 for the year ended December 31, 2024, as compared to a net loss of $52.3 million, or basic and diluted net loss per share attributable to common stockholders of $0.73 for the same period in 2023. 1 Tsuboyama M, Lee Kaye H, Rotenberg A. Biomarkers Obtained by Transcranial Magnetic Stimulation of the Motor Cortex in Epilepsy. Front Integr Neurosci. 2019 Oct 30;13:57. doi: 10.3389/fnint.2019.00057. PMID: 31736722; PMCID: PMC6837164. About Ovid Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need. The Company is advancing a pipeline of novel, highly specific, small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders. Ovid is developing: OV329, a next-generation GABA-aminotransferase inhibitor, as a potential therapy for treatment-resistant seizures and other undisclosed indications; OV350, and a library of compounds that directly activate the KCC2 transporter, for multiple neurological and psychiatric conditions; and OV888/GV101, a highly selective ROCK2 inhibitor for undisclosed neurovascular and neuro-inflammatory conditions. For more information about these and other Ovid research programs, please visit www.ovidrx.com. Forward-Looking Statements This press release includes certain disclosures by Ovid that contain “forward-looking statements” including, without limitation: statements regarding the expected timing of initiation, completion, and results and data of Ovid’s clinical studies; Ovid’s expectations regarding the duration of its cash runway and the expectation that it will support Ovid’s operations and development programs; Ovid’s ability to achieve expected benefits of cost-savings efforts; Ovid’s ability to secure additional sources of funding; Ovid’s potential future business development opportunities; the potential use and development of OV329, OV350 and other compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101; the potential therapeutic opportunity of OV329, OV350 and other compounds from Ovid’s library of direct activators of KCC2, and OV888/GV101; Ovid’s evaluation of the results of recently completed competitor trials to OV888/GV101 for CCM; and other statements that are not historical fact. You can identify forward-looking statements because they contain words such as “anticipates,” “believes,” “expects,” “intends,” “may,” “plan,” “potentially,” and “will,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Forward-looking statements are based on Ovid’s current expectations and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that may differ materially from those contemplated by the forward-looking statements, which are neither statements of historical fact nor guarantees or assurances of future performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, uncertainties inherent in the preclinical and clinical development and regulatory approval processes, impediments to Ovid’s ability to achieve expected benefits of cost-savings efforts, risks related to Ovid’s ability to achieve its financial objectives, the risk that Ovid may not be able to realize the intended benefits of its business strategy, or risks related to Ovid’s ability to identify business development targets or strategic partners, to enter into strategic transactions on favorable terms, or to consummate and realize the benefits of any business development transactions. Additional risks that could cause actual results to differ materially from those in the forward-looking statements are set forth under the caption “Risk Factors” in Ovid’s most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”), and in subsequent and future filings Ovid makes with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and Ovid assumes no obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. Contacts Investor Relations & Media Victoria Fort VFort@ovidrx.com

MAPLE GROVE, Minn., Dec. 2, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced its participation at AES 2024, the Annual Meeting of the American Epilepsy Society, from December 6-10, 2024 in Los Angeles, California, where it will present a range of events, including Innovation Pavilion presentations and two scientific posters featuring new data on its medications for infantile spasms. Upsher-Smith's parent company, Bora Pharmaceuticals Co., Ltd., recently acquired US-based Pyros Pharmaceuticals Inc., a leader in the development of enhanced specialty pharmaceuticals for rare diseases. The acquisition added VIGAFYDE™ (vigabatrin) Oral Solution to Upsher-Smith's portfolio of rare disease medications, making it the third vigabatrin formulation to be offered by Upsher-Smith, alongside VIGADRONE® (vigabatrin) Powder for Oral Solution and Tablets. VIGAFYDE™ is the first and only ready-to-use vigabatrin oral solution and is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years, where the potential benefits outweigh the potential risk of vision loss. VIGAFYDE™ is the first new drug application (NDA) approved for this condition in 15 years and represents a welcome expansion of vigabatrin treatment options, enabling customization of therapy to best meet the needs of individual patients and caregivers. Innovation Pavilion Presentations The Company also invites attendees to visit the Innovation Pavilion for informative presentations on vigabatrin between the hours of 12:30 pm – 1:30 pm on Saturday, December 7, 2024, Sunday, December 8, 2024, and Monday, December 9, 2024. The Innovation Pavilion is located in the exhibit hall (South Hall H, Level 1). Scientific Posters for Presentation Include: Dissolution and Stability of Vigabatrin Powder in Water, Fruit Juice, Milk, and Infant Formula Poster 2.407; Sunday, December 8, 2024; 10 a.m. – 4 p.m. PST Authors to present 12 p.m. to 2 p.m. Los Angeles Convention Center, South Lobby, Street Level, South Hall H, Level 1 Comparison of Vigabatrin Oral Solution Versus Vigabatrin (SABRIL®) Powder for Oral Solution in Infantile Spasms by Caregivers Poster 2.398; Sunday, December 8, 2024; 10 a.m. – 4 p.m. PST Authors to present 12 p.m. to 2 p.m. Los Angeles Convention Center, South Lobby, Street Level, South Hall H, Level 1 Abstracts of the poster presentations can be found online at . To schedule an interview with a study author, please contact Elizabeth Likly at [email protected]. Upsher-Smith representatives will also be available at its commercial booths throughout the conference to engage with clinicians about its products. Products include the new ready-to-use vigabatrin solution, VIGAFYDE™ at Booth #1439, and VIGADRONE® Powder for Oral Solution and Tablets and the Promise of Support™ Program, which has been providing comprehensive support to patients prescribed VIGADRONE® since 2018, at Booth #1627. About Upsher-Smith's Promise of Support™ Program Central to Upsher-Smith's commitment to rare disease communities is its Promise of Support™ Program, ensuring comprehensive assistance for patients, caregivers, and healthcare providers throughout the treatment journey. For nearly a decade, the program has offered resources for uninterrupted medication supply, prior authorization support, patient education materials, collaboration with a leading specialty pharmacy partner, and streamlined prescribing and enrollment procedures. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families. To learn more about Upsher-Smith, its products, and the Promise of Support™ Program visit: . Vigabatrin REMS All vigabatrin products are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. The Vigabatrin REMS ensures that patients and healthcare providers make informed risk-benefit decisions about its use. Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them. IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin) What is the most important information I should know about VIGAFYDE? VIGAFYDE can cause serious side effects, including: Permanent vision loss: VIGAFYDE can damage the vision of anyone who takes it. Some babies can have severe loss, particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called "tunnel vision"). Your baby also may have blurry vision. If this happens, it will not get better. Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal. Vision loss in babies: Because of the risk of vision loss, VIGAFYDE is used in babies 1 month to 2 years of age with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGAFYDE are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGAFYDE or within 4 weeks after starting VIGAFYDE, and every 3 months after that until VIGAFYDE is stopped. Your baby also should have a vision test about 3 to 6 months after VIGAFYDE is stopped. Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGAFYDE, but they will not be able to watch for any vision loss. Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is severe and permanent. All babies who take VIGAFYDE: Are at risk for permanent vision loss with any amount of VIGAFYDE. The risk of vision loss may increase with higher doses of VIGAFYDE, and the longer it is taken. It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped. Because VIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will explain the details of the Vigabatrin REMS to you. For more information, go to or call 1-866-244-8175. Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS): brain pictures taken by MRI show changes in some babies after they are given VIGAFYDE. It is not known if these changes are harmful. What are the possible side effects of VIGAFYDE? VIGAFYDE can cause serious side effects, including sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable) and weight gain without swelling. Serious side effects that happen in adults who take vigabatrin and are not known if they will happen in babies are low red blood cell counts, nerve problems, and swelling. Tell your baby's healthcare provider right away if your baby's seizures get worse. The most common side effects of VIGAFYDE in babies include sleepiness, ear infection, swelling of the bronchial tubes, and irritability. Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away. These are not all the possible side effects of VIGAFYDE. Do not stop taking VIGAFYDE suddenly. This can cause serious problems. Talk to your healthcare provider for directions on how to stop treatment. What should I tell my healthcare provider before starting VIGAFYDE? Before giving VIGAFYDE to your baby for IS, inform your healthcare provider about all your baby's medical conditions. This includes whether your baby has ever had an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing, as well as any history of vision problems, or kidney issues. Tell your healthcare provider about all the medicines your baby takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGAFYDE and other medicines could lead to side effects. You may report side effects to the FDA at or call 1-800-FDA-1088 or Pyros at 1-855-406-1010. Please see full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use for additional Important Safety Information. WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE® (vigabatrin)? Because VIGADRONE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you. VIGADRONE can damage the vision of anyone who takes it. Some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called "tunnel vision"). You may also have blurry vision. If this happens, it will not get better. Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred. Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child's) vision before or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed. Vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in patients, until it is severe. If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss. Magnetic resonance imaging (MRI) changes in patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGADRONE. It is not known if these changes are harmful. A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of patients treated with vigabatrin. Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you. Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop. VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse. Before starting VIGADRONE, tell your doctor about all of your (or your child's) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to VIGADRONE, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illnesses. Tell your doctor about all the medicines you (or your child) take. If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby. Breastfeeding is not recommended. If you are pregnant or plan to become pregnant, VIGADRONE can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant. The most common side effects of VIGADRONE in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness. The most common side effect of VIGADRONE in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults. The most common side effects of VIGADRONE in babies include: sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable), swelling in the bronchial tubes (bronchitis), ear infection and irritability. Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. This is the most important information to know about VIGADRONE, but it is not all the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGADRONE.com, upsher-smith.com or call 1-888-650-3789. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-332-1088. WHAT IS VIGADRONE? VIGADRONE® (vigabatrin) is a prescription medicine used to treat: Infantile Spasms (IS) in patients 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking VIGADRONE are more important than the possible risk of vision loss. Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) along with other treatments if: The CPS do not respond well enough to several other treatments, and You and your healthcare provider decide the possible benefit of taking VIGADRONE is more important than the risk of vision loss. VIGADRONE should not be the first medicine used to treat CPS. About Upsher-Smith Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit . About Bora Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit . VIGADRONE and Promise of Support are trademarks of Upsher-Smith Laboratories, LLC. VIGAFYDE is a trademark of Pyros Pharmaceuticals, Inc. SOURCE Upsher-Smith Laboratories, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED