Could It Be the Drops? Not-Too-Uncommon Complications from Glaucoma Medications
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Brimonidine Tartrate; Brinzolamide
Contains Nonbinding Recommendations Draft Guidance on Brimonidine Tartrate ; Brinzolamide This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Brimonidine tartrate; Brinzolamide Dosage Form; Route: Suspension/drops; ophthalmic Strength: 0.2%; 1% Recommended Studies: One study Type of study: Bioequivalence (BE) study with clinical endpoint Design: Randomized (1:1), double-masked, parallel, two-arm, in vivo Strength: 0.2%; 1% Subjects: Males and females with chronic open angle glaucoma or ocular hypertension in both eyes. Additional comments: Specific recommendations are provided below. ______________________________________________________________________________ Analytes to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (95% CI): Clinical endpoint Additional comments regarding the BE study with clinical endpoint: 1. The Office of Generic Drugs (OGD) recommends conducting a BE study with a clinical endpoint in the treatment of open angle glaucoma and ocular hypertension comparing the test product to the reference listed drug (RLD), each applied as one drop in both eyes three times daily at approximately 8:00 a.m., 4:00 p.m., and 10:00 p.m. for 42 days (6 weeks). 2. Inclusion criteria (the sponsor may add additional criteria): a. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes b. -
AZARGA, INN-Brinzolamide/Timolol
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT AZARGA 10 mg/ml + 5 mg/ml eye drops, suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml of suspension contains 10 mg brinzolamide and 5 mg timolol (as timolol maleate). Excipient with known effect: One ml of suspension contains 0.10 mg benzalkonium chloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, suspension (eye drops) White to off-white uniform suspension, pH 7.2 (approximately). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction (see section 5.1). 4.2 Posology and method of administration Posology Use in adults, including the elderly The dose is one drop of AZARGA in the conjunctival sac of the affected eye(s) twice daily. When using nasolacrimal occlusion or closing the eyelids, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity (see section 4.4). If a dose is missed, treatment should be continued with the next dose as planned. The dose should not exceed one drop in the affected eye (s) twice daily. When substituting another ophthalmic antiglaucoma medicinal product with AZARGA, the other medicinal product should be discontinued and AZARGA should be started the following day. Special populations Paediatric population The safety and efficacy of AZARGA in children and adolescents aged 0 to 18 years have not yet been established. -
Looking for New Classes of Bronchodilators
REVIEW BRONCHODILATORS The future of bronchodilation: looking for new classes of bronchodilators Mario Cazzola1, Paola Rogliani 1 and Maria Gabriella Matera2 Affiliations: 1Dept of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy. 2Dept of Experimental Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy. Correspondence: Mario Cazzola, Dept of Experimental Medicine, University of Rome Tor Vergata, Via Montpellier 1, Rome, 00133, Italy. E-mail: [email protected] @ERSpublications There is a real interest among researchers and the pharmaceutical industry in developing novel bronchodilators. There are several new opportunities; however, they are mostly in a preclinical phase. They could better optimise bronchodilation. http://bit.ly/2lW1q39 Cite this article as: Cazzola M, Rogliani P, Matera MG. The future of bronchodilation: looking for new classes of bronchodilators. Eur Respir Rev 2019; 28: 190095 [https://doi.org/10.1183/16000617.0095-2019]. ABSTRACT Available bronchodilators can satisfy many of the needs of patients suffering from airway disorders, but they often do not relieve symptoms and their long-term use raises safety concerns. Therefore, there is interest in developing new classes that could help to overcome the limits that characterise the existing classes. At least nine potential new classes of bronchodilators have been identified: 1) selective phosphodiesterase inhibitors; 2) bitter-taste receptor agonists; 3) E-prostanoid receptor 4 agonists; 4) Rho kinase inhibitors; 5) calcilytics; 6) agonists of peroxisome proliferator-activated receptor-γ; 7) agonists of relaxin receptor 1; 8) soluble guanylyl cyclase activators; and 9) pepducins. They are under consideration, but they are mostly in a preclinical phase and, consequently, we still do not know which classes will actually be developed for clinical use and whether it will be proven that a possible clinical benefit outweighs the impact of any adverse effect. -
WO 2014/066775 Al 1 May 2014 (01.05.2014) W P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2014/066775 Al 1 May 2014 (01.05.2014) W P O PCT (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61F 9/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/US20 13/066834 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, 25 October 2013 (25.10.201 3) KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, (25) Filing Language: English OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, (26) Publication Language: English SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (30) Priority Data: ZW. 61/719,144 26 October 2012 (26. 10.2012) US (84) Designated States (unless otherwise indicated, for every (71) Applicant: FORSIGHT VISION5, INC. [US/US]; 191 kind of regional protection available): ARIPO (BW, GH, Jefferson Drive, Menlo Park, CA 94025 (US). GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, (72) Inventors: RUBIN, Anne, Brody; 191 Jefferson Drive, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, Menlo Park, CA 94025 (US). -
Estonian Statistics on Medicines 2016 1/41
Estonian Statistics on Medicines 2016 ATC code ATC group / Active substance (rout of admin.) Quantity sold Unit DDD Unit DDD/1000/ day A ALIMENTARY TRACT AND METABOLISM 167,8985 A01 STOMATOLOGICAL PREPARATIONS 0,0738 A01A STOMATOLOGICAL PREPARATIONS 0,0738 A01AB Antiinfectives and antiseptics for local oral treatment 0,0738 A01AB09 Miconazole (O) 7088 g 0,2 g 0,0738 A01AB12 Hexetidine (O) 1951200 ml A01AB81 Neomycin+ Benzocaine (dental) 30200 pieces A01AB82 Demeclocycline+ Triamcinolone (dental) 680 g A01AC Corticosteroids for local oral treatment A01AC81 Dexamethasone+ Thymol (dental) 3094 ml A01AD Other agents for local oral treatment A01AD80 Lidocaine+ Cetylpyridinium chloride (gingival) 227150 g A01AD81 Lidocaine+ Cetrimide (O) 30900 g A01AD82 Choline salicylate (O) 864720 pieces A01AD83 Lidocaine+ Chamomille extract (O) 370080 g A01AD90 Lidocaine+ Paraformaldehyde (dental) 405 g A02 DRUGS FOR ACID RELATED DISORDERS 47,1312 A02A ANTACIDS 1,0133 Combinations and complexes of aluminium, calcium and A02AD 1,0133 magnesium compounds A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 811120 pieces 10 pieces 0,1689 A02AD81 Aluminium hydroxide+ Magnesium hydroxide (O) 3101974 ml 50 ml 0,1292 A02AD83 Calcium carbonate+ Magnesium carbonate (O) 3434232 pieces 10 pieces 0,7152 DRUGS FOR PEPTIC ULCER AND GASTRO- A02B 46,1179 OESOPHAGEAL REFLUX DISEASE (GORD) A02BA H2-receptor antagonists 2,3855 A02BA02 Ranitidine (O) 340327,5 g 0,3 g 2,3624 A02BA02 Ranitidine (P) 3318,25 g 0,3 g 0,0230 A02BC Proton pump inhibitors 43,7324 A02BC01 Omeprazole -
Risk Factors Leading to Trabeculectomy Surgery Of
Shirai et al. BMC Ophthalmology (2021) 21:153 https://doi.org/10.1186/s12886-021-01897-4 RESEARCH ARTICLE Open Access Risk factors leading to trabeculectomy surgery of glaucoma patient using Japanese nationwide administrative claims data: a retrospective non-interventional cohort study Chikako Shirai1, Satoru Tsuda1, Kunio Tarasawa2, Kiyohide Fushimi3, Kenji Fujimori2* and Toru Nakazawa1* Abstract Background: Early recognition and management of baseline risk factors may play an important role in reducing glaucoma surgery burdens. However, no studies have investigated them using real-world data in Japan or other countries. This study aimed to clarify the risk factors leading to trabeculectomy surgery, which is the most common procedure of glaucoma surgery, of glaucoma patient using the Japanese nationwide administrative claims data associated with the diagnosis procedure combination (DPC) system. Methods: It was a retrospective, non-interventional cohort study. Data were collected from patients who were admitted to DPC participating hospitals, nationwide acute care hospitals and were diagnosed with glaucoma between 2012 to 2018. The primary outcome was the risk factors associated with trabeculectomy surgery. The association between baseline characteristics and trabeculectomy surgery was identified using multivariable logistic regression analysis by comparing patients with and without trabeculectomy surgery. Meanwhile, the secondary outcomes included the rate of comorbidities, the rate of concomitant drug use and the treatment patterns of -
Latanoprost Ophthalmic Emulsion
Contains Nonbinding Recommendations Draft Guidance on Latanoprost This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Latanoprost Dosage Form; Route: Emulsion; ophthalmic Strength: 0.005% Recommended Study: One study Type of study: Bioequivalence (BE) study with clinical endpoint Design: Randomized (1:1), double-masked, parallel, two-arm, in vivo Strength: 0.005% Subjects: Males and females with chronic open angle glaucoma or ocular hypertension in both eyes Additional comments: Specific recommendations are provided below Analyte s to measure (in appropriate biological fluid): Not applicable Bioequivalence based on (95% CI): Clinical endpoint Additional comments regarding the BE study with clinical endpoint: 1. The Office of Generic Drugs (OGD) recommends conducting a BE study with a clinical endpoint in the treatment of open angle glaucoma and ocular hypertension comparing the test product to the reference standard (RS) product, each applied as one drop in both eyes once daily in the evening for 42 days (6 weeks). 2. Inclusion criteria (the applicant may add additional criteria): a. Male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes. b. Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. -
AZARGA® Eye Drops Brinzolamide 10 Mg/Ml and Timolol 5 Mg/Ml CONSUMER MEDICINE INFORMATION
AZARGA® Eye Drops Brinzolamide 10 mg/mL and timolol 5 mg/mL CONSUMER MEDICINE INFORMATION What Is In This Leaflet Although AZARGA helps control your glaucoma, it does not cure it. Please read this leaflet carefully For more information about before you use any AZARGA Eye What AZARGA is used glaucoma, contact Glaucoma drops. for Australia on 1800 500 880 or Glaucoma New Zealand on 09 373 This leaflet answers some common AZARGA is used to lower pressure 8779. questions about AZARGA. It does in the eye and to treat glaucoma. not contain all of the available Glaucoma is a condition in which the Your doctor may have prescribed information. It does not take the pressure of fluid in the eye may be AZARGA for another reason. Ask place of talking to your doctor or high. However, some people with your doctor if you have any questions pharmacist. glaucoma may have normal eye about why AZARGA has been The information in this leaflet was pressure. prescribed for you. last updated on the date listed on the Glaucoma is usually caused by a There is no evidence that AZARGA final page. More recent information build-up of the fluid which flows is addictive. on the medicine may be available. through the eye. This build up occurs You should ensure that you speak because the fluid drains out of your Use in Children to your pharmacist or doctor to eye more slowly than it is being There is not enough information to obtain the most up to date pumped in. Since new fluid continues recommend the use of this medicine information on the medicine. -
Safety and Efficacy of SIMBRINZA BID As an Adjunctive to DUOTRAV
Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 1 of 71 a Novartis company Short Title Safety and Efficacy of SIMBRINZA BID as an Adjunctive to DUOTRAV Long Title Safety and Efficacy with Twice Daily Brinzolamide 1% / Brimonidine 0.2% (SIMBRINZA) as an Adjunctive Therapy to Travoprost 0.004% / Timolol 0.5% (DUOTRAV) Protocol Number: GLJ576-P001/ NCT02730871 Study Phase: 4 Sponsor Name and Alcon Research, Ltd. Address: 6201 South Freeway Fort Worth, Texas 76134-2099 Investigational Product: SIMBRINZA Brinzolamide 1% (10 mg/mL)/Brimonidine 0.2% (2 mg/mL) eye drops suspension US IND# / EudraCT 2016-000176-20 Indication Studied: Ocular Hypertension Open Angle Glaucoma Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 2 of 71 Investigator Agreement: I have read the clinical study described herein, recognize its confidentiality, and agree to conduct the described trial in compliance with Good Clinical Practices (GCP), the ethical principles contained within the Declaration of Helsinki, this protocol, and all applicable regulatory requirements. Additionally, I will comply with all procedures for data recording and reporting, will permit monitoring, auditing, and inspection of my research center, and will retain all records until notified by the Sponsor. Principal Investigator: Signature Date Name: Address: Printed By: Print Date: Alcon - Business Use Only Protocol - Clinical Effective Date: 10-Apr-2017 Document: TDOC-0051572 Version: 2.0; Most-Recent; Effective; CURRENT Status: Effective Page 3 of 71 1 SYNOPSIS Sponsor: Alcon Research, Ltd. -
Achievements and Limits of Current Medical Therapy of Glaucoma
Bettin P, Khaw PT (eds): Glaucoma Surgery. 2nd, revised and extended edition. Dev Ophthalmol. Basel, Karger, 2017, vol 59, pp 1–14 ( DOI: 10.1159/000458482 ) Achievements and Limits of Current Medical Therapy of Glaucoma Pelagia Kalouda · Christina Keskini · Eleftherios Anastasopoulos · Fotis Topouzis Laboratory of Research and Clinical Applications in Ophthalmology, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki , Greece Abstract ery systems are being investigated to open new horizons Prescribing medical therapy for the treatment of glauco- in glaucoma management. Although the general rule is ma can be a complex process since many parameters to initiate glaucoma management with medical treat- should be taken into consideration regarding its achieve- ment, the limits of medical therapy should be considered ments and limits. Today, a variety of options, including to identify those patients in need of surgical manage- multiple drug classes and multiple agents within classes, ment. © 2017 S. Karger AG, Basel are available to the clinician, but caution should be given to their side effects and contraindications. Glaucoma pa- tients with preexisting ocular surface disease should be State of the Art treated with caution, and preferably with preservative- free formulations, as there is an increased risk for symp- Glaucoma is a medical term describing a group of tom deterioration. The development and use of progressive optic neuropathies characterized by fixed-combination therapies has reduced the preserva- the degeneration of retinal ganglion cells and of tive-related side effects that threaten patient adherence the retinal nerve fiber layer, resulting in changes and has minimized the washout effect of multiple instil- in the optic nerve head. -
(Ripasudil Hydrochloride Hydrate), a Rho Kinase Inhibitor, Has Been Approved in Singapore
PRESS RELEASE March 11, 2020 Dear all Kowa Company, Ltd. K-115 (Ripasudil Hydrochloride Hydrate), a Rho Kinase Inhibitor, has been approved in Singapore Kowa Company, Ltd. (Headquarters: Nagoya, Japan, President & CEO: Yoshihiro Miwa, hereafter referred to as "Kowa") announced that "Ripasudil Hydrochloride Hydrate" (hereafter refer to as “Ripasudil”), a Rho kinase inhibitor, for the indications of Open-Angle Glaucoma and Ocular Hypertension has been approved by HSA (Health Sciences Authority) in Singapore. Ripasudil has been developed as a global product, and was launched in December 2014 in Japan (Brand name: GLANATEC® ophthalmic solution 0.4%) as the world's first glaucoma drug with Rho kinase inhibitory activity. Ripasudil is the first Rho kinase inhibitor filed and approved by HSA. Kowa plans to establish a direct sales system to support the marketing of Ripasudil. Following this approval in Singapore, Kowa continues efforts to gain approval for Ripasudil in counties all over the world. Kowa focuses on sensory organ diseases as one of its key therapeutic areas, especially ocular disorders. Kowa is developing Ripasudil for corneal endothelial diseases, as well as a fixed- dose combination (Ripasudil Hydrochloride Hydrate / Brimonidine Tartrate) in patients with glaucoma or ocular hypertension. In addition, Kowa markets intraocular lenses for cataracts, and seeks to address other unmet medical needs. GLANATEC® Ophthalmic Solution 0.4% GLANATEC® Ophthalmic Solution 0.4% includes Ripasudil as an active ingredient, and lowers intraocular pressure by promoting discharge of aqueous humor through a main outflow via trabecular meshwork-Schlemm’s canal as a result of Rho kinase inhibitory activity. In clinical studies enrolling patients with primary open-angle glaucoma and ocular hypertension in Japan, GLANATEC® Ophthalmic Solution 0.4% has been demonstrated to be effective in lowering intraocular pressure in both cases of mono-therapy and conjunctival therapy along with conventional treatment-glaucoma and ocular hypertension drugs. -
Intraocular Pressure-Lowering Effect of Ripasudil Hydrochloride Hydrate
ISSN: 2378-346X Kawara et al. Int J Ophthalmol Clin Res 2018, 5:083 DOI: 10.23937/2378-346X/1410083 Volume 5 | Issue 1 International Journal of Open Access Ophthalmology and Clinical Research RESEARCH ARTICLE Intraocular Pressure-Lowering Effect of Ripasudil Hydrochloride Hy- drate and Reasons for Discontinuation of Use in Clinical Practice Kana Kawara, Akiyasu Kanamori, Sotaro Mori, Yukako Inoue, Takuji Kurimoto, Sentaro Kusuhara, Yuko Yamada and Makoto Nakamura* Check for Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, Japan updates *Corresponding author: Makoto Nakamura, Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan, E-mail: [email protected] that are commonly used include prostaglandin ana- Abstract log, which enhances uveoscleral outflow, adrenergic Background: To evaluate the intraocular pressure (IOP)-low- β-blocker and carbonic anhydrase inhibitor (CAI), which ering effect of ripasudil hydrochloride hydrate and the reasons for the discontinuation of its use in glaucomatous eyes with at reduce aqueous humor production, or adrenergic α2 least 2 ocular hypotensive medications. stimulant, which performs both mechanisms. The clin- Design: Retrospective case series. ical application of drugs that modify the conventional outflow pathway through trabecular meshwork and the Methods: We reviewed the medical records of 116 consec- utive patients with primary open angle, secondary, or de- Schlemm canal has been limited, except for pilocarpine velopmental glaucoma. The pre- and post-application IOP for pupillary block release, because of its insufficient up to 6 months after the initiation of ripasudil application IOP-lowering ability.