Randomized, Double-blind, Cross-over Clinical Trial to Assess Onset of Action and Efficacy of Azelastine Hydrochloride 0.15% Nasal Spray in the Treatment of Allergen-Induced Allergic Rhinitis Symptoms in an Environmental Exposure Unit in Comparison to Placebo and Mometasone Furoate/Olopatadine Hydrochloride Nasal Spray

This study is to assess the Onset of Action and Efficacy of azelastine hydrochloride 0.15% in treating the nasal symptoms of seasonal allergic rhinitis (SAR) induced by an allergen challenge in an Environmental Exposure Unit (EEU) followed by a single dose and a 3-day treatment at home.

Start Date30 Oct 2023

Sponsor / Collaborator

MEDA Pharma GmbH & Co. KG

CTR20233096 / CompletedNot Applicable

盐酸奥洛他定颗粒在健康受试者中的单剂量、空腹和餐后、随机、开放、两周期、两交叉生物等效性研究

[Translation] A single-dose, fasting and fed, randomized, open-label, two-period, two-crossover bioequivalence study of olopatadine hydrochloride granules in healthy subjects

主要研究目的：本研究以成都倍特药业股份有限公司生产的盐酸奥洛他定颗粒[0.5%（0.5g/袋）]为受试制剂，原研日本協和キリン株式会社生产的盐酸奥洛他定颗粒[0.5%（0.5g/袋），商品名：Allelock®]为参比制剂，评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main research purpose: This study uses olopatadine hydrochloride granules [0.5% (0.5g/bag)] produced by Chengdu Beite Pharmaceutical Co., Ltd. as the test preparation, and the original research product is olopatadine hydrochloride produced by Japan Kyowa Kirin Co., Ltd. Fixed granules [0.5% (0.5g/bag), trade name: Allelock®] are used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions. Secondary research purpose: To observe the safety of test preparation and reference preparation in healthy subjects.

Start Date25 Oct 2023

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

100 Clinical Results associated with Olopatadine Hydrochloride

100 Translational Medicine associated with Olopatadine Hydrochloride

100 Patents (Medical) associated with Olopatadine Hydrochloride

380

Literatures (Medical) associated with Olopatadine Hydrochloride

01 Apr 2024·Eye (London, England)

Exploration of efficacy and mechanism of 0.05% cyclosporine eye drops (II) monotherapy in allergic conjunctivitis-associated dry eye

Article

Author: Qi, Yuanyuan ; Yang, Ruibo ; Zhao, Shaozhen ; Zhang, Chen ; Jiao, Xiting ; Gao, Ning

PURPOSE:

To explore the efficacy and relevant mechanism of 0.05% cyclosporine A (CsA) eye drops (II) monotherapy in patients with allergic conjunctivitis-associated dry eye (ACDE).

METHODS:

Prospective, randomized, controlled study. Fifty-three patients with mild-to-moderate ACDE were randomly assigned to two groups. The CsA group received 0.05% CsA eye drops (II) monotherapy four times daily. The control group received 0.1% olopatadine twice daily combined with 0.1% preservative-free artificial tears four times daily. Clinical symptoms and signs, tear total IgE, and lymphotoxin-α (LT-α) concentrations were assessed at pre- and post-treatment days 7, 30, and 60. And we further measured six tear cytokines levels using a microsphere-based immunoassay.

RESULTS:

The CsA group showed significant improvement in symptoms (Ocular Surface Disease Index and itching scores) and signs (conjunctival hyperaemia, conjunctival oedema, conjunctival papillae, tear break-up time (TBUT), corneal fluorescein staining, and goblet cell density) at each follow-up period compared to pre-treatment (all P < 0.050). And its improvement in itching scores (P_7th < 0.001, P_30th = 0.039, and P_60th = 0.031) and TBUT (P_7th = 0.009, P_30th = 0.003, and P_60th = 0.005) was more significant than the control group at all follow-up periods. The tear total IgE, interleukin (IL)-5, IL-6, periostin, eotaxin-3, and MMP-9 levels significantly decreased in the CsA group at day 60 after treatment (all P < 0.050). And the changed values in tear total IgE were positively correlated with the change in itching scores.

CONCLUSIONS:

0.05% CsA eye drops (II) monotherapy can rapidly improve the symptoms and signs, especially in ocular itching and TBUT, in patients with ACDE. And its efficacy is superior to 0.1% olopatadine combined with artificial tears. Moreover, CsA downregulates the expression levels of tear inflammatory cytokines, including tear total IgE, IL-5, IL-6, periostin, eotaxin-3, and MMP-9. Among that, the reduction in tear total IgE levels may reflect the improvement of ocular itching.

01 Feb 2024·Inflammopharmacology

Protective effect of olopatadine hydrochloride against LPS-induced acute lung injury: via targeting NF-κB signaling pathway

Article

Author: Rana, Priyanka ; Kaur, Jaspreet ; Kondepudi, Kanthi Kiran ; Pawar, Sandip V ; Matta, Tushar ; Kuhad, Anurag ; Dhingra, Neelima ; Kaur, Tanzeer ; Sodhi, Rupinder Kaur ; Pathania, Khushboo ; Sah, Sangeeta Pilkhwal

BACKGROUND:

Morbidity and mortality rates associated with acute lung injury/acute respiratory distress syndrome (ALI/ARDS) are high (30-40%). Nuclear factor-kappa B (NF-κB) is a transcription factor, associated with transcription of numerous cytokines leading to cytokine storm, and thereby, plays a major role in ALI/ARDS and in advanced COVID-19 syndrome.

METHODS:

Considering the role of NF-κB in ALI, cost-effective in silico approaches were utilized in the study to identify potential NF-κB inhibitor based on the docking and pharmacokinetic results. The identified compound was then pharmacologically validated in lipopolysaccharide (LPS) rodent model of acute lung injury. LPS induces ALI by altering alveolar membrane permeability, recruiting activated neutrophils and macrophages to the lungs, and compromising the alveolar membrane integrity and ultimately impairs the gaseous exchange. Furthermore, LPS exposure is associated with exaggerated production of various proinflammatory cytokines in lungs.

RESULTS:

Based on in silico studies Olopatadine Hydrochloride (Olo), an FDA-approved drug was found as a potential NF-κB inhibitor which has been reported for the first time, and considered further for the pharmacological validation. Intraperitoneal LPS administration resulted in ALI/ARDS by fulfilling 3 out of the 4 criteria described by ATS committee (2011) published workshop report. However, treatment with Olo attenuated LPS-induced elevation of proinflammatory markers (IL-6 and NF-κB), oxidative stress, neutrophil infiltration, edema, and damage in lungs. Histopathological studies also revealed that Olo treatment significantly ameliorated LPS-induced lung injury, thus conferring improvement in survival. Especially, the effects produced by Olo medium dose (1 mg/kg) were comparable to dexamethasone standard.

CONCLUSION:

In nutshell, inhibition of NF-κB pathway by Olo resulted in protection and reduced mortality in LPS- induced ALI and thus has potential to be used clinically to arrest disease progression in ALI/ARDS, since the drug is already in the market. However, the findings warrant further extensive studies, and also future studies can be planned to elucidate its role in COVID-19-associated ARDS or cytokine storm.

01 Sep 2023·Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

The rising cost of rhinologic medications

Article

Author: Nguyen, Theodore V ; Birkenbeuel, Jack L ; Meller, Leo L T ; Michelle, Lauren ; Torabi, Sina J ; Roman, Kelsey M ; Kuan, Edward C ; Vasudev, Milind

BACKGROUND:

The high prescription drug cost in the United States may negatively affect patient prognosis and treatment compliance.

OBJECTIVE:

To fill the knowledge gap and inform clinicians regarding rhinology medications price changes by evaluating trends in price changes of highly used nasal sprays and allergy medications.

METHODS:

The 2014-2020 Medicaid National Average Drug Acquisition Cost database was queried for drug pricing information for the following classes of medications: intranasal corticosteroids, oral antihistamines, antileukotrienes, intranasal antihistamines, and intranasal anticholinergics. Individual medications were identified by Food and Drug Administration-assigned National Drug Codes. Per unit, drug prices were analyzed for average annual prices, average annual percentage price changes, and inflation-adjusted annual and composite percentage price changes.

RESULTS:

Beclometasone (Beconase AQ, 56.7%, QNASL, 77.5%), flunisolide (Nasalide, -14.6%), budesonide (Rhinocort Aqua, -1.2%), fluticasone (Flonase, -6.8%, Xhance, 11.7%), mometasone (Nasonex, 38.2%), ciclesonide (Omnaris, 73.8%), combination azelastine and fluticasone (Dymista, 27.3%), loratadine (Claritin, -20.5%), montelukast (Singulair, 14.5%), azelastine (Astepro, 21.9%), olopatadine (Patanase, 27.3%), and ipratropium bromide (Atrovent, 56.6%) had an overall change in inflation-adjusted per unit cost between 2014 and 2020 (% change). Of 14 drugs evaluated, 10 had an increase in inflation-adjusted prices, for an average increase of 42.06% ± 22.27%; 4 of 14 drugs had a decrease in inflation-adjusted prices, for an average decrease of 10.78% ± 7.36%.

CONCLUSION:

The rising cost of highly used medications contributes to increased patient acquisition costs and may pose barriers of drug adherence to particularly vulnerable populations.

News (Medical) associated with Olopatadine Hydrochloride

01 Feb 2024

·www.biospace.com

Opthea Strengthens Team with Key Clinical and Regulatory Hires

Dr. Julie Clark, SVP Clinical Development; Dr. Fang Li, SVP Regulatory Affairs, to join February 1st Experienced executives bring extensive track record in products for retinal and ophthalmology diseases MELBOURNE, Australia, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced the appointment of Julie Clark, MD, MS, as Senior Vice President (SVP), Clinical Development, and Fang Li, Ph.D. RAC, as SVP, Regulatory Affairs, effective February 1, 2024. Dr. Clark and Dr. Li will report to Opthea Chief Executive Officer, Frederic Guerard, PharmD, MS, and will join the Opthea Executive Management Team. “It is my great pleasure to welcome two ophthalmology experts, Dr. Clark and Dr. Li, to the Company as we prepare for the next stage in our growth and work towards advancing the development of sozinibercept (OPT-302),” said Dr. Guerard. “Their past contributions to the development and registration of ophthalmology therapies such as IZERVAY™, BEOVU®, and EYLEA®, will be instrumental to the potential success of our lead program investigating sozinibercept, currently in two Phase 3 pivotal trials.” Dr. Clark shared, “I am thrilled to join Opthea as we prepare to complete patient enrollment in the pivotal Phase 3 clinical program for sozinibercept in the first half of 2024. The majority of my career has been dedicated to the clinical development of novel therapies for retinal diseases. Sozinibercept could be the first new drug for wet age-related macular degeneration (AMD) in more than 15 years, with the potential to deliver superior visual gains when administered in combination with standard of care therapy. I look forward to contributing to bringing this novel product candidate to patients with serious retinal disease.” Dr. Li commented, “As we work towards the potential release of topline results for our Phase 3 program in mid-2025, I am excited to apply my expertise to support the development and execution of our regulatory strategy and potential filings for sozinibercept in the U.S. and other markets. I look forward to the opportunity to bring Opthea’s innovative potential medicine through the regulatory process for the benefit of patients with retinal diseases.” Julie Clark, MD, MS With more than 15 years of experience in ophthalmology medical and clinical development, Dr. Clark brings expertise in both early and late-stage programs, regulatory submissions, and approvals. Her contributions include substantial support for the approval and launches of retinal therapies such as EYLEA®, JETREA® and BEOVU®. In Dr. Clark’s most recent position as Vice President Clinical Development at IVERIC bio, Inc., An Astellas Company, she oversaw the development program leading to the August 2023 U.S. Food and Drug Administration (FDA) approval of IZERVAY™, a complement inhibitor approved for the treatment of geographic atrophy secondary to age-related macular degeneration. Dr. Clark previously served as Chief Medical Officer at Adverum Biotechnologies Inc, where she played a crucial role in developing intravitreal delivered gene therapy for retinal diseases. Dr. Clark is a graduate of Wake Forest University and Wake Forest University School of Medicine in Winston-Salem, NC, U.S. Fang Li, PhD, RAC Dr. Li brings over 30 years of expertise in drug development and more than 20 years in regulatory affairs experience. Her experience spans various domains including small molecules, biologics, gene therapy, over-the-counter products, in-vitro diagnostic products and medical devices, with a specific focus on ophthalmology. She has held key roles at prominent ophthalmology companies such as Novartis AG, Alcon Inc., and Bausch + Lomb Corporation. Dr. Li's extensive background includes significant involvement in health authority interactions, U.S. FDA advisory committee meeting preparation and the establishment and leadership of regulatory teams. She has a proven track record of success in obtaining product approvals in the U.S. and other regions. Throughout her career, Dr. Li has played a pivotal role in leading numerous FDA drug approvals, specifically contributing to the approval of ophthalmology products like JETREA®, LOTEMAX® Ointment, SYSTANE® COMPLETE. She has also contributed to the development and registration of other ophthalmology drug products such as BEOVU®, PAZEO®, LOTEMAX® GEL, BESIVANCE®, and VYZULTA®. Fang holds a PhD in Medicinal Chemistry from China Pharmaceutical University, China. About Opthea Opthea Limited (ASX:OPT; NASDAQ:OPT, “Opthea”) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including neovascular (wet) age-related macular degeneration (wet AMD). Opthea’s lead product candidate sozinibercept is being evaluated in two pivotal Phase 3 clinical trials (ShORe, NCT04757610, and COAST, NCT04757636) for use in combination with standard-of-care anti-VEGF-A monotherapies to improve overall efficacy and deliver superior vision gains compared to standard-of-care. To learn more, visit and follow us on X and LinkedIn. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking Statements This ASX announcement contains certain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. The words “expect”, “believe,” “should”, “could”, “may”, “will”, “plan” and other similar expressions are intended to identify forward-looking statements. Forward-looking statements in this ASX announcement include statements regarding expectations on the outcomes of Opthea’s Phase 3 clinical trials of sozinibercept, the potential for sozinibercept as a combination therapy to be the first therapy to achieve superior visual outcomes over anti-VEGF-A monotherapy and improve vision outcomes for patients with wet AMD, the expected timing for completion of enrollment for the Phase 3 studies and topline data, the market opportunity for sozinibercept, and the future performance of Opthea. Forward-looking statements, opinions and estimates provided in this ASX announcement are based on assumptions and contingencies which are subject to change without notice, as are statements about market and industry trends, which are based on interpretations of current conditions. Forward-looking statements are provided as a general guide only and should not be relied upon as an indication or guarantee of future performance. They involve known and unknown risks and uncertainties and other factors, many of which are beyond the control of Opthea and its directors and management and may involve significant elements of subjective judgment and assumptions as to future events that may or may not be correct. These statements may be affected by a range of variables which could cause actual results or trends to differ materially, including but not limited to future capital requirements, the development, testing, production, marketing and sale of drug treatments, regulatory risk and potential loss of regulatory approvals, ongoing clinical studies to demonstrate sozinibercept safety, tolerability and therapeutic efficacy, additional analysis of data from Opthea’s Phase 3 clinical trials, timing of completion of Phase 3 clinical trial patient enrollment and clinical research organization and labor costs, intellectual property protections, and other factors that are of a general nature which may affect the future operating and financial performance of the Company including risk factors set forth in Opthea’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on September 28, 2023 and other future filings with the SEC. Actual results, performance or achievement may vary materially from any projections and forward-looking statements and the assumptions on which those statements are based. Subject to any continuing obligations under applicable law or any relevant ASX listing rules, Opthea disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statements in this ASX announcement to reflect any change in expectations in relation to any forward-looking statements or any change in events, conditions or circumstances on which any such statement is based, except as otherwise required by applicable law. Authorized for release to ASX by Frederic Guerard, CEO Company & Media Enquiries: Rudi Michelson Monsoon Communications Tel: +61 (0) 3 9620 3333 Investor Enquiries PJ Kelleher LifeSci Advisors Email: pkelleher@lifesciadvisors.com Join our email database to receive program updates: Tel: +61 (0) 3 9826 0399 Email: info@opthea.com Web:

Phase 3Executive ChangeDrug Approval

26 Oct 2023

·www.prnewswire.com

Nanoscope Therapeutics Strengthens Research and Development Leadership with Appointment of Najam Sharif, PhD, DSc.

DALLAS, Oct. 26, 2023 /PRNewswire/ -- Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases, today announced the appointment of Najam Sharif, PhD, DSc, a veteran in drug/device discovery and development, as Vice President of Global Research and Development. "We are delighted to welcome Naj to the Nanoscope team," said Sulagna Bhattacharya, Co-Founder and Chief Executive Officer of Nanoscope. "His extensive experience in ophthalmology and pharmaceutical drug discovery and development is a natural fit for our organization, and we look forward to drawing on his clinical and regulatory expertise in particular at this pivotal time for MCO-010." "I am honored to join Nanoscope, a company that I see as transformative in the field of ophthalmology. As their lead asset, MCO-010, advances toward FDA approval, I look forward to the opportunity to positively impact the lives of people living with inherited retinal diseases, and to bring treatment options to a population for which there are no established cures," said Dr. Sharif. Dr. Naj Sharif brings over three decades of experience in pharmaceutical drug/device discovery and development to Nanoscope, including specialized expertise in ophthalmology and neuroscience. Throughout his career, he contributed to the discovery and development of several FDA-approved commercial drugs, including anti-glaucoma agent Travatan® and anti-allergic/inflammatory drugs such as Patanol® /Pataday® and Emedine®. In addition, Dr. Sharif was instrumental in guiding three drugs through to FDA approvals: Simbrinza® for glaucoma, IZBA® for the treatment of ocular hypertension and glaucoma, and PAZEO™ for the treatment ocular allergies. Most recently, Dr. Sharif served as Vice President, Global Biomedical Sciences & Head of Glaucoma and Neuroprotection at Santen, where he managed the company's Clinical Sciences, Data Sciences, and Biometrics departments, and where he also established and directed Global Alliances & External Research activities. Prior to this, he held positions related to R&D and regulatory affairs at Alcon Research-Novartis, Synaptic Pharmaceutical Corp, and Syntex Pharma / Roche Pharmaceutical Corp. He is widely published with an extensive number of peer-reviewed publications, edited books and holds multiple patents for mitigation of neurological and ophthalmic diseases. He has been an invited organizer, chairman and speaker at multiple national and international conferences. In addition to his professional experience, Dr. Sharif has served on numerous boards and committees. Dr. Sharif is an elected Fellow of multiple learned societies such as Association for Research in Vision and Ophthalmology, Association for Ocular Pharmacology and Therapeutics and British Pharmacological Society. Currently he serves on the Scientific Advisory Board of the Glaucoma Foundation and as an adjunct professor for the Duke-NUS Medical School in Singapore, and Institute of Ophthalmology at University College London. He is the recipient of several honors, including the Ernst H. Barany prize for "Outstanding Contributions to Ocular Pharmacology", the first and inaugural "Dr. Roger Vogel Award" for Pharmaceutical Research, and the Sir James Black Award for "Contributions to Drug Discovery". Dr. Sharif received a PhD in neuroscience, DSc (by thesis) in ophthalmology, and dual bachelor's degree in physiology and biochemistry from the University of Southampton (UK). About Nanoscope Therapeutics Inc. Nanoscope Therapeutics is developing gene-agnostic, sight-restoring optogenetic therapies for the millions of patients blinded by inherited retinal diseases, for which no cure exists. The company's lead asset, MCO-010, recently reported topline results from the RESTORE Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trial in the U.S. for retinitis pigmentosa (NCT04945772). The company has also recently completed their end-of-study visit for the Phase 2 STARLIGHT trial of MCO-010 therapy in Stargardt patients (NCT05417126). MCO-010 has received FDA fast track designations and FDA orphan drug designations for both retinitis pigmentosa and Stargardt. Preclinical assets include non-viral laser-delivered MCO-020 gene therapy for geographic atrophy. Investor Contact: Argot Partners 212-600-1902 [email protected] SOURCE Nanoscope Therapeutics

Phase 2Orphan DrugClinical ResultExecutive ChangeFast Track

11 May 2023

·www.drugs.com

The Most Common Allergy Medicines

THURSDAY, May 11, 2023 -- If you suffer from allergies, you know how bothersome and uncomfortable the sneezing and itchy eyes can be. These symptoms are more than irritating — they impact day-to-day activities like work, school, sports, sleeping and even eating. Not only that, but allergies can also cause more serious health problems such as asthma and even anaphylaxis, a life-threatening allergic reaction. Allergies are a common health condition affecting almost one-third of adults in the United States and just over one-quarter of children under 17, according to the U.S. Centers for Disease Control and Prevention . But there is relief at hand: Here’s what you need to know about the most common allergy medicines, the type of allergies they treat, how they work and common side effects. Antihistamines This type of allergy medicine is very effective in relieving allergy symptoms. Mayo Clinic explains this drug type works by blocking histamine, “a symptom-causing chemical released by your immune system during an allergic reaction.” Antihistamines are available as an over-the-counter medication or as a prescription allergy medicine, and they are sold in oral form, as a nasal spray or as eyedrops. This allergy medicine treats symptoms of indoor and seasonal allergies. Common side effects of antihistamines include drowsiness, dry mouth, dizziness, blurred or double vision, mucous thickening and low blood pressure. Common antihistamines include: Oral Loratadine (Alavert, Claritin) Cetirizine (Zyrtec) Diphenhydramine (Benadryl) Doxylamine (Vicks NyQuil, Tylenol Cold and Cough Nighttime) Fexofenadine (Allegra) Nasal spray Olopatadine (Patanase) Eyedrops Ketotifen (Zaditor) Leukotriene modifiers Leukotriene modifiers prevent or lessen the symptoms of allergic rhinitis (hay fever) and allergic asthma. The Cleveland Clinic explains that leukotrienes are chemicals released in the body when you come in contact with an allergen. This causes symptoms like a runny nose and coughing. Leukotriene inhibitors block the effects leukotrienes have on the body or “stop your body from producing them.” This allergy medicine treats symptoms of indoor and seasonal allergies. Leukotriene inhibitors can cause side effects such as cold or flu symptoms, headache, diarrhea, fatigue and itchy skin or rash. More serious side effects like depression, thoughts of suicide, hives, trouble breathing, vomiting and yellowing of the skin or eyes can occur. You should seek medical treatment in these cases. Common leukotriene inhibitors include: Montelukast (Singulair) Zafirlukast (Accolate) Zileuton (Zyflo) Corticosteroids Corticosteroids treat mild to severe allergy symptoms by reducing inflammation caused by your body’s reaction to an allergen. Corticosteroids are available in several forms including pills and liquids, nasal sprays, inhalers, creams and eyedrops. They treat allergic inflammation caused by indoor and seasonal allergens as well as insect stings. Severe allergic reactions are treated with oral corticosteroids, according to the Mayo Clinic. Side effects vary depending on the medication form, but can include increased blood glucose levels, high blood pressure, nosebleeds, mouth and throat irritation, and skin irritation. Common corticosteroids by form include: Pills and liquids Prednisolone (Prelone) Methylprednisolone (Medrol) Nasal sprays Budesonide (Rhinocort) Mometasone (Nasonex) Inhalers Fluticasone (Flovent) Mometasone (Asmanex Twisthaler) Creams Betamethasone (Dermabet, Diprolene) Desonide (Desonate, DesOwen) Eyedrops Fluorometholone (Flarex, FML) Loteprednol (Alrex, Lotemax) Immunotherapy Immunotherapy works by modifying the immune system and its reaction to allergens. It’s not used for immediate allergy symptom relief but is a long-term allergy treatment. Immunotherapy treatments (or allergy shots) are prescription medicines. "Allergy shots can be helpful for patients with seasonal and year-round allergies," Miranda Curtiss , an assistant professor at the University of Alabama at Birmingham School of Medicine, said in a recent article . "However, these are a long-term investment that require planning to continue therapy for three to five years for maximal benefit. Asthmatics who want to start allergy shots need to have their asthma under good control first before starting shots." With allergy shots, you are exposed to an allergen over and over until your immune system becomes desensitized and no longer reacts to the allergen, the Mayo Clinic says. This type of treatment is commonly given as allergy shots (subcutaneous immunotherapy, or SCIT), but is also available in a form given under the tongue (sublingual immunotherapy, or SLIT). With SCIT, injections are given in your doctor’s office where they can monitor for adverse reactions. Treatment starts with the “build-up phase,” which is once or twice a week, and decreases to a maintenance dose which is once every two to four weeks. Sublingual immunotherapy treatment, like subcutaneous immunotherapy, also exposes you to allergens over a period of time, with the goal of building immunity to the allergen. SLIT tablets are available by prescription and taken daily. Immunotherapy is used to treat seasonal and indoor allergies, as well as insect stings. Side effects include watery eyes, sneezing, mild asthma symptoms, a rash at the injection site, tiredness and headaches. In rare cases, life-threatening reactions such as throat swelling and difficulty breathing can occur. Regardless of the type of allergy or your symptoms, there are options for relief. Reach out to your health care provider to learn more about which remedies are best for you. Posted May 2023

Immunotherapy

100 Deals associated with Olopatadine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01192	Olopatadine Hydrochloride	R01AC08 S01GX09	DB00768

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	US	Novartis Pharmaceuticals Corp.	15 Apr 2008
Allergic rhinoconjunctivitis	JP	Novartis Pharma KK	26 Jul 2006
Seasonal allergic conjunctivitis	EU	Novartis Europharm Ltd.	16 May 2002
Seasonal allergic conjunctivitis	IS	Novartis Europharm Ltd.	16 May 2002
Seasonal allergic conjunctivitis	LI	Novartis Europharm Ltd.	16 May 2002
Seasonal allergic conjunctivitis	NO	Novartis Europharm Ltd.	16 May 2002
Pruritus	JP	Kyowa Kirin Co., Ltd.	22 Dec 2000
Rhinitis, Allergic	JP	Kyowa Kirin Co., Ltd.	22 Dec 2000
Urticaria	JP	Kyowa Kirin Co., Ltd.	22 Dec 2000
Conjunctivitis, Allergic	US	Alcon Laboratories, Inc.	18 Dec 1996

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AAAAI2019	Not Applicable	Rhinitis, Allergic, Seasonal	-	GSP301 (olopatadine 665μg/mometasone 25μg BID)	njlgodijfh(bitlwkrmav) = vmbljkojkp iuvspobbww (phazzmdibq, -0.41 to -0.05)	-	01 Feb 2019
NCT00609128 (CTgov)	Not Applicable	Conjunctivitis, Allergic \| Lacerations	21	olopatadine	vppgvuhbqs(jmqyaxmiqv) = wackinwbkn ffwobgunvh (vafpsinyue, rnhbnspmaa - rbhrancwwz) View more	-	20 Sep 2018
AAAAI2018	Not Applicable	Ragweed Sensitivity	180	GSP301 BID	qenwqcrizy(futuwkgnhp) = GSP301 BID had a rapid onset of action of 10 minutes and provided significant improvements in ocular symptoms vs placebo jomtpfyeeg (mcphjofsmq )	Positive	01 Feb 2018
AAAAI2018	Not Applicable	Rhinitis, Allergic, Seasonal	-	GSP301 (olopatadine 665μg/mometasone 25μg BID)	tztkolvdoy(ldncjzabmz) = hliaoscznf sqlehmfzyb (bzhxkjgaqf, -0.35[-0.63 - -0.07])	-	01 Feb 2018
NCT01697969 (CTgov)	Phase 4	Conjunctivitis, Allergic	17	Olopatadine hydrochloride (Left Eye)	oditvqgrgn(milskhfugz) = jbctnvhquv zwmvpzawar (sgcmlaesqs, ndgkaunlil - kvpfkapsdn) View more	-	18 Aug 2014
				Olopatadine hydrochloride (Right Eye)	oditvqgrgn(milskhfugz) = fvwuzbcygh zwmvpzawar (sgcmlaesqs, uimdexmnqu - ublfuftppg) View more
NCT01743027 (CTgov)	Phase 3	Conjunctivitis, Allergic	902	AL-4943A ophthalmic solution (AL-4943A)	znfrpylifo(jluwdcbstw) = wkixsabeid ekgvxullru (epqjywaqxo, hvcogjvjrr - jfiyfgyphv) View more	-	11 Aug 2014
				Olopatadine hydrochloride ophthalmic solution, 0.2% (PATADAY)	znfrpylifo(jluwdcbstw) = osvluamxdt ekgvxullru (epqjywaqxo, bbpsyxccgs - meqdbpomzq) View more
NCT01698814 (CTgov)	Phase 3	Conjunctivitis, Allergic	518	AL-4943A Ophthalmic Solution (AL-4943A)	afewoxhdzi(nxvnncjdgc) = vwiecqlxoq sjjrmjgqax (xnmhvhknwr, lktwlmmmmx - lzjtkqglje) View more	-	28 Feb 2014
				AL-4943A Ophthalmic Solution Vehicle (AL-4943A Vehicle)	afewoxhdzi(nxvnncjdgc) = lxkrzorgik sjjrmjgqax (xnmhvhknwr, zeoatczgex - kcbukskmlh) View more
NCT01732757 (CTgov)	Phase 4	Acute conjunctivitis \| Conjunctivitis, Allergic	157	Alcaftadine 0.25% (Lastacaft®)	ithnpdkahh(egvtfntlbr) = fpzwlkjgro jqmktcowdk (vvekstcyuk, pxzcmhfqlr - eoejamwjwr) View more	-	14 Jan 2014
				Olopatadine 0.2% (Pataday™)	ithnpdkahh(egvtfntlbr) = mnnpezzuns jqmktcowdk (vvekstcyuk, thvbkvzouu - myukoqlzlj) View more
NCT01479374 (CTgov)	Phase 3	Conjunctivitis, Allergic	397	AL-4943A ophthalmic solution (AL-4943A)	bigtusulqd(zxcaxqvpdj) = fzalwudfoa uoteynpqdv (fqymrsrxsi, xmulqxgwgk - izkcsfjpjg) View more	-	23 May 2013
				AL-4943A vehicle (Vehicle)	bigtusulqd(zxcaxqvpdj) = bgaddruzjg uoteynpqdv (fqymrsrxsi, faycgkmocn - hpkghxlmto) View more
NCT01119287 (CTgov)	Phase 4	Conjunctivitis, Allergic	180	Dexamethasone 0.1% ophthalmic suspension (Maxidex)	nlbhbcumsk(ipcwkadqns) = htihgbuvmi zvazxaqbjv (hlkglhmvxb, aredqwfchb - cmnzjooxvr) View more	-	06 Mar 2013
				Olopatadine hydrochloride 0.1% ophthalmic solution (Patanol)	nlbhbcumsk(ipcwkadqns) = wjiebsrrrz zvazxaqbjv (hlkglhmvxb, fcnmezfgby - vusmwyywld) View more

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