Breaking News
September 21, 2018 - CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL
September 21, 2018 - Study offers solid link between visceral organs and brain’s reward, motivation system
September 21, 2018 - First U.S. patient treated with innovative gene therapy at Bascom Palmer Eye Institute
September 21, 2018 - Choroidal Detachment – The American Society of Retina Specialists
September 21, 2018 - Discovery of a key protein involved in the development of autism
September 21, 2018 - Henry Ford Health System receives $600k grant to study genetic makeup of gliomas
September 21, 2018 - Arthritis common in individuals with varying degrees of depression, finds study
September 21, 2018 - New research suggests link between PFAS chemicals and hyperthyroidism in pet cats
September 21, 2018 - Multi-year study data shows impact of new soft contact lens to slow myopia progression in children
September 21, 2018 - Neuroscientists identify circuit for brain’s statistical inference about motion
September 21, 2018 - MILabs’ VECTor6 system wins Commercial Innovation Award at WMIC 2018
September 21, 2018 - Scientists find wild African monkeys infected with bacterium that causes syphilis, yaws in humans
September 21, 2018 - 2006 to 2015 Saw Increase in Severe Maternal Morbidity
September 21, 2018 - Similar changes in the brains of patients with ADHD and emotional instability
September 21, 2018 - Cobalt mining in DR Congo takes a high toll on both creuseurs and environment
September 21, 2018 - Eating fatty fish during pregnancy may boost unborn child’s brain development
September 21, 2018 - Study reveals promising new drug candidate to treat acute renal failure
September 21, 2018 - Neural signal that urges to eat overpowers the one that says to stop
September 21, 2018 - Scientists achieve breakthrough in accelerated diagnosis of multi-resistant hospital pathogens
September 21, 2018 - Researchers simulate how different breast tissues respond to heat from MRIs
September 21, 2018 - Despite red flags at surgery centers, overseers award gold seals
September 21, 2018 - Zapping Airway Nerves May Help COPD Patients Breathe
September 21, 2018 - Researchers find answers as to why some people are at risk of gout
September 21, 2018 - Stars of Stanford Medicine: Genetic counseling and compassion
September 21, 2018 - Researchers use reinforcement learning to train gliders to soar like birds
September 21, 2018 - New federally-funded research project could lead to treatments that extend human lifespan
September 21, 2018 - Health insurance ads have shifted over time due to health plans offered via ACA
September 21, 2018 - Use of transcranial electrical stimulation to bolster creativity has far-reaching implications
September 21, 2018 - Scientists find way to boost efficacy of powerful antimalarial drug with anti-cancer medicines
September 21, 2018 - Weighing the risks and benefits of drug tapering—two patients, two perspectives
September 21, 2018 - The “exposome” revealed: a barrage of bacteria, chemicals, microscopic animals and more
September 21, 2018 - Top three immune boosting recommendations to ward off freshers’ flu
September 21, 2018 - Young children’s oral microbiota could serve as early indicator for obesity
September 21, 2018 - Older individuals with multiple sclerosis report higher quality of life than younger counterparts
September 21, 2018 - LineaRx signs agreement with Takis/Evvivax to develop linear-DNA based anti-cancer vaccines
September 21, 2018 - AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress
September 21, 2018 - Alzheimer’s drug may stop disease if used before symptoms develop
September 21, 2018 - Human skeletal stem cell can generate cartilage, bone
September 21, 2018 - UK and European research collaborations receive vote of confidence by three major cancer charities
September 21, 2018 - Microbiota in the intestines and cell stress cause colon cancer
September 20, 2018 - Arizona EMTs have 39% higher risk for suicide than general public
September 20, 2018 - Driving and older adults: MedlinePlus Medical Encyclopedia
September 20, 2018 - Brain region for stress control is enlarged in people with depression, finds study
September 20, 2018 - Researchers test autobiographical memory for early Alzheimer’s detection
September 20, 2018 - Organizations join forces to help teens with severe mental health challenges | News Center
September 20, 2018 - Neurons in the human brain can encode numerical information
September 20, 2018 - Potential drugs to treat neurodegenerative diseases garner $3 million grant
September 20, 2018 - Processing speed important to higher order cognitive function in multiple sclerosis patients
September 20, 2018 - Helping a patient survive a hurricane
September 20, 2018 - Tafamidis Treats Transthyretin Amyloid Cardiomyopathy
September 20, 2018 - Low academic achievement can lead to drug abuse decades later, research finds
September 20, 2018 - Study identifies stem cell that gives rise to new bone, cartilage in humans | News Center
September 20, 2018 - Celltrion and Emory University sign ‘Incubation’ agreement to develop new drug candidates for atherosclerosis
September 20, 2018 - TGen and PNOC take part in launch of NIH-supported Kids First Data Resource Portal
September 20, 2018 - Could Household Cleaners Make Your Kid Fat?
September 20, 2018 - Addiction nonprofit makes searching for services simple
September 20, 2018 - We are bombarded by thousands of diverse species and chemicals | News Center
September 20, 2018 - Experts to Present Prostate Cancer Advances at Patient Summit
September 20, 2018 - Alector announces initiation of Phase 1 trial of AL001 for treating frontotemporal dementia
September 20, 2018 - Pfizer’s 20vPnC vaccine receives Breakthrough Therapy designation from FDA
September 20, 2018 - Study could allow doctors to screen patients at risk from Aspergillus
September 20, 2018 - Emergex signs MoU with Brazil’s Fiocruz for development of viral vaccines
September 20, 2018 - The ‘real you’ is a myth – we constantly create false memories to achieve the identity we want
September 20, 2018 - Researchers describe cell mechanism that optimizes proteins production in stressful situations
September 20, 2018 - Cell Medica successfully doses first patient with CMD-501 targeting pediatric neuroblastoma
September 20, 2018 - Sesen Bio to present its three-month Phase 3 VISTA Trial data at Global Congress
September 20, 2018 - Senators unveil legislation to protect patients against surprise medical bills
September 20, 2018 - Study provides insights into development of special-purpose cosmetic products
September 20, 2018 - Research shows enlarged genotype-phenotype correlation for three-base pair deletion in NF1
September 20, 2018 - 91% of people around the world believe medical research will result in dementia cure
September 20, 2018 - DePuy Synthes introduces CONCORDE LIFT Expandable Interbody Device at EUROSPINE 2018
September 20, 2018 - Manx Telecom unveils MT clearSound that improves clarity of mobile phone calls
September 20, 2018 - Mediterranean-style diet appears to reduce stroke risk in women
September 20, 2018 - AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis
September 20, 2018 - Characterization of pregnancy microbiome reveals variations in bacterial diversity
September 20, 2018 - New guidance for treatment of bone loss in hematologic stem cell transplant Recipients
September 20, 2018 - Experts to present research on prevention, management of dysphagia at international conference
September 20, 2018 - New study focuses on two-way gene switches controlling gene activity
September 20, 2018 - Zika virus could become a weapon against brain cancer
September 20, 2018 - Home-based video game exercises can reduce chronic low back pain in older people, study finds
Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease

Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease

image_pdfDownload PDFimage_print

Sun Pharma Announces FDA Approval of Cequa (cyclosporine) Ophthalmic Solution to Treat Dry Eye Disease

MUMBAI, India & PRINCETON, N.J.–(BUSINESS WIRE)– August 16, 2018 — Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that Sun Pharma has received approval for Cequa (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). Cequa is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Cequa provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration. In the Phase 3 confirmatory trial on Cequa, after 12 weeks of treatment, as compared to vehicle, Cequa showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p

The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA.

“Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of Cequa represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. Cequa, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.”

Additionally, Jodi Luchs, MD, the principal investigator behind the Cequa confirmatory Phase 3 trial, noted: “Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of Cequa is welcomed news, and I look forward to offering my patients this compelling new option.”

Cequa (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.

About Cequa

Cequa (cyclosporine A, ophthalmic solution) is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study, 744 patients with dry eye were treated either with Cequa or its vehicle. After 12 weeks of treatment, as compared to vehicle, Cequa showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p

INDICATIONS AND USAGE

Cequa (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

Use with Contact Lenses: Cequa should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of Cequa ophthalmic solution.

ADVERSE REACTIONS

The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

About Dry Eye Disease

Dry eye is a burdensome, chronic disease affecting millions of patients around the world, with a significant population, greater than 16 million patients, present in the United States.

Dry eye disease, as defined by the National Eye Institute (NEI, a division of the U.S. National Institutes of Health [NIH]), occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated. The disease causes a scratchy sensation or a feeling that something is in the eye. Other symptoms include stinging or burning, episodes of excess tearing following periods of stress, discharge, pain, and redness in the eye. The risk of developing dry eye increases with advancing age, and is more common in women than in men.

Disclaimer: Statements in this “Document” describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

About Sun Ophthalmics

Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% in the U.S. Other candidates in Sun Ophthalmics’ development pipeline include Xelpros™ (latanoprost ophthalmic solution) 0.005% and DexaSite™ (dexamethasone) 0.1%. Sun Ophthalmics’ dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine. Discover a brighter future in eye care at www.sunophthalmics.com.

About Sun Pharmaceutical Industries Ltd.

Sun Pharma is the world’s fifth largest specialty generic pharmaceutical company and India’s top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma’s global presence is supported by 41 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. In India, the company enjoys leadership across 13 different classes of doctors with 32 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 3 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of approximately 8% of annual revenues. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

Source: Sun Pharmaceutical Industries Ltd.

Posted: August 2018

Cequa (cyclosporine) FDA Approval History

Tagged with:

About author

Related Articles