Kerato conjunctivitis sicca

Presentation at the American Academy of Optometry (AAOPT) 2023 showed significant improvements with CEQUA® for topical ophthalmic use in both corneal fluorescein staining (CFS) and symptom questionnaire scores starting at 4 weeks and continuing to 12 weeks Study design mirrors real-world experience with dry eye disease, including allowing use of artificial tears and measurement of CFS in all five corneal zones MUMBAI, India and PRINCETON, N.J., Oct. 12, 2023 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) today announced the presentation of Phase 4 data showing that CEQUA® (cyclosporine ophthalmic solution) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED). CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). In a presentation at the American Academy of Optometry (AAOPT) 2023 annual meeting in New Orleans, La., researchers reported that CEQUA elicited significant improvement in corneal fluorescein staining (CFS, a test used to detect damage to the cornea) and in modified Symptom Assessment in Dry Eye (mSANDE) scores in patients with DED whose disease was uncontrolled on Restasis® (cyclosporine ophthalmic emulsion) 0.05% therapy.1 In the 12-week Phase 4 multicenter study, twice-daily administration of CEQUA improved CFS and mSANDE scores starting at Week 4 of treatment and maintained these improvements through Week 12. CEQUA offers a high concentration of cyclosporine for ophthalmic use and is the first and only U.S. Food and Drug Administration (FDA)-approved cyclosporine treatment delivered with nanomicellar NCELL® technology, which helps to improve the bioavailability of cyclosporine, resulting in improved ocular tissue penetration. "We were greatly encouraged to observe significant improvements in dry eye signs and symptoms as early as four weeks into treatment with CEQUA, and to see even greater improvements at eight weeks and again at 12 weeks," said lead investigator Josh Johnston, OD, FAAO, of Georgia Eye Partners in Atlanta, Ga. "Moreover, by assessing corneal fluorescein staining in all five zones of the cornea, we were able to attain a more complete characterization of corneal health than in many dry eye disease trials, which typically assess only a few corneal areas." The study enrolled adults with DED inadequately controlled (i.e., still symptomatic and/or exhibiting disease signs) on current Restasis® therapy for at least three months, and who had a history and clinical diagnosis of DED for at least three months before screening/baseline. Patients received one drop of CEQUA in each eye twice daily for 12 weeks. Investigators assessed CFS and mSANDE scores at baseline and at Weeks 4, 8, and 12, and/or upon early discontinuation from the study. CFS was scored on a 0-4 grading scale in 0.5-point increments, with a score of 0 indicating no stain (i.e., healthy cornea) and a score of 4 reflecting a severe stain; investigators calculated a total CFS score by summing all five corneal area scores. The mSANDE questionnaire assessed frequency and severity of DED symptoms of dryness and irritation on a 0-100 scale, with 0 representing very low frequency/severity and 100 indicating very high frequency/severity. Dr. Johnston and colleagues presented results from 124 patients in the modified intent-to-treat (mITT) population. The mean (standard deviation [SD]) age of the patients was 65.5 (11.6) years; 110 of the patients (88%) were female. The mean (SD) total CFS score was 5.7 (3.37) at baseline, and improved significantly (P <0.0001) to 4.0 (3.12) at Week 4, 2.9 (2.54) at Week 8, and 2.7 (2.36) at Week 12. Similarly, the mean (SD) mSANDE score was 67.1 (21.05) at baseline and improved significantly (P <0.0001) to 48.4 (23.31) at Week 4, 44.2 (24.28) at Week 8, and 38.3 (25.99) at Week 12. CEQUA was generally well tolerated in the study, consistent with its established safety profile, and there were no new safety signals in the trial. Overall, 58 patients (43.3%) reported at least one treatment-emergent adverse event (AE); most AEs were mild in severity (73.8%). The most common treatment-related AEs were instillation site irritation and instillation site pain; all other treatment-related AEs occurred in fewer than 2% of patients. "In addition to the rapid and sustained symptomatic improvement in patients with dry eye disease treated with CEQUA, this study is notable for its design, which allows for use of artificial tears, thus replicating real-world conditions as closely as possible for a controlled clinical trial," noted Brittany Mitchell, OD, Head of Medical Affairs, Ophthalmics, at Sun Pharma. "The data presented at the American Academy of Optometry meeting represent the first of a series of assessments from this trial, with results thus far consistent with the efficacy, safety, and convenient dosing of CEQUA. We look forward to sharing additional information as we continue to analyze the data from this trial." About CEQUA® CEQUA® (cyclosporine ophthalmic solution) 0.09% is a patented, novel, proprietary nanomicellar NCELL formulation of cyclosporine in a clear, preservative-free, aqueous solution. It is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.2 CEQUA is the first and only U.S. Food and Drug Administration (FDA)-approved cyclosporine treatment delivered with nanomicellar NCELL technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration. CEQUA is dosed twice daily and is available as a single-use vial. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study involving 744 patients with dry eye, investigators observed clinically and statistically significant improvements in tear production and ocular surface integrity in patients treated with CEQUA, compared to vehicle. CEQUA treatment was well tolerated in the Phase 3 trial; treatment-emergent adverse events were primarily mild in intensity. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated clinically and statistically significant increases in tear production (16.8% of patients with an increase of ≥10 mm in Schirmer's score from baseline after 84 days of treatment, versus 8.6% for vehicle; p<0.01) and was well tolerated by the study population. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. From both clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis, urinary tract infection, headache, and bronchitis. 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. Please click for Full Prescribing Information & for more information visit CEQUAPRO.com 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.2 Dry eye disease, as defined by the National Eye Institute (NEI, a division of the U.S. National Institutes of Health), 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 ophthalmic 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. In addition to CEQUA® (cyclosporine ophthalmic solution) 0.09%, Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% and XELPROS® (latanoprost ophthalmic solution) 0.005% in the U.S. 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 . About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050) Sun Pharma is the world's fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 16% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on Twitter @SunPharma_Live References: Johnston, J. Effect of OTX-101 0.09% on corneal staining and SANDE scores in patients with dry eye disease uncontrolled on cyclosporine ophthalmic emulsion 0.05%. Abstract presented at American Academy of Optometry 2023; October 12, 2023; New Orleans, LA. New study focuses on scope of dry eye disease in the U.S. American Optometric Association; 2017. Available at: . Accessed September 10, 2019 © 2023 Sun Pharmaceutical Industries, Inc. All trademarks are the property of their respective owners. Company Codes: Bombay:524715, India:EQSUNPHARMA

FinancialNewsMedia.com News Commentary PALM BEACH, Fla., Sept. 8, 2023 /PRNewswire/ -- The Global Dry Eye Syndrome market has been growing substantially in the past years and is expected to continue through 2030. Dry Eye Syndrome (DES) or Dry Eye Disease (DES), which is also called Keratoconjunctivitis Sicca (KCS), is a common ophthalmic condition that occurs when the person doesn't have enough quality tears to lubricate or nourish the eye. The symptoms include redness, stinging, scratching, or burning sensation, light sensitivity, watery eyes, and stringy mucus near the eye and blurry vision. As per an article published by the BMC Ophthalmology in February 2022, signs of eye dryness were reported in 5–30% of the elderly subjects, and the frequency of dry eye was 8.4% for those less than 60 years, 15% among 70-79 years, and 20% for patients over 80 years. Moreover, with increasing age, the ability of the lacrimal glands to produce tears decreases leading to this condition. The condition has also been more prevalent amongst postmenopausal women. A study was published by the National Library of Medicine in June 2021, in a group of 1947 perimenopausal and postmenopausal women, aged between 45 and 79 years, where the overall prevalence of DED symptoms was 79%, and was increasing significantly in postmenopausal women. These trends will lead to an increase in demand for therapeutic measures and contribute to the growth of the global market during the forecast period. A report from Fortune Business Insights projected that the global dry eye syndrome market size was valued at USD 6.61 billion in 2022 and is projected to grow from USD 7.02 billion in 2023 to USD 11.26 billion by 2030, exhibiting a CAGR of 7.0% during the forecast period. Active biotech companies in the markets this week include: OKYO Pharma Limited (NASDAQ: OKYO), Alcon (NYSE: ALC), Bausch + Lomb Corporation (NYSE: BLCO), Johnson & Johnson (NYSE: JNJ), Roche (OTCQX: RHHBY). The Fortune Business Insights report said: "After the outbreak of COVID-19, several medical associations reported a spike in cases of dry eye due to continuous use of face masks among people. Also, as the incidence of other infectious diseases, especially air borne diseases grows, the adoption of masks is expected to continue in the forecast period. This prevailing trend will drive the adoption rate of these products leading to market growth during the forecast period (2030). One of the critical drivers that positively impacts the global market is the extensive increase in the global prevalence of this condition. The prevalence of this chronic condition varies with age. However, the prevalence is increasing in the young as well as the older population due to growing usage of screens, improper diet, growing use of contact lenses, and rise in the number of LASIK surgeries. Increase in the prevalence will propel the demand for more effective therapeutic measures for this disease, which will drive the dry eye syndrome market growth during the forecast period." OKYO Pharma Limited (NASDAQ: OKYO) BREAKING NEWS: OKYO Pharma Completes Enrollment in Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease Full enrollment achieved on September 6th with a total of 240 patients enrolled in study Top-line data planned for release in December 2023 Phase 2 trial is designed as a potential registration trial, with pre-specified primary efficacy endpoints covering both a sign and symptom of DED OKYO Pharma Limited, a clinical stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory dry eye disease ("DED), a multi-billion-dollar market, and for neuropathic corneal pain ("NCP"), a severe ocular condition with no FDA approved therapy, is pleased to announce that it has completed full enrollment of patients in the randomized portion of the Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat DED. A total of 240 patients have been enrolled in the study. "This trial began in May of this year, and we have been pleased with the rapid pace of enrollment in the trial which has been managed by our clinical development partner Ora Inc., a world leader in dry eye clinical research," said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. "We now have 240 patients enrolled in the trial and are anticipating the last-patient last-visit to occur in the last week of November 2023, with the planned release of top-line data occurring in December 2023." "The Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in the population of 240 DED patients comprising the study," said Raj Patil, Ph.D., CSO of OKYO Pharma. "We remain committed to establishing the potential of this drug to treat the many millions of people currently suffering from DED." DED is a common condition that occurs when one's tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the United States alone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition. Several contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface and pain. CONTINUED… Read this full release and more news for OKYO Pharma at: Other recent developments in the biotech industry include: Alcon (NYSE: ALC), the global leader in eye care, recently reported its financial results for the three and six months ended June 30, 2023. For the second quarter of 2023, sales were $2.4 billion, an increase of 9% on a reported basis and 12% on a constant currency basis, as compared to the same quarter of the previous year. Alcon reported diluted earnings per share of $0.34 and core diluted earnings per share of $0.69 in the second quarter of 2023. David J. Endicott, Alcon's Chief Executive Officer, said, "Our robust second quarter results reflect the durability of our markets, the commercial excellence of our team and our unwavering focus on innovation." Mr. Endicott continued, "By successfully executing our strategy around the world and across both franchises, we are further strengthening our leadership position in eye care, making us more resilient in a complex global economy and better positioned to seize new opportunities to advance patient care and deliver shareholder value." Bausch + Lomb Corporation (NYSE: BLCO), a leading global eye health company dedicated to helping people see better to live better, recently announced that it has disclosed certain historical and pro forma financial information with respect to its proposed acquisition of XIIDRA (lifitegrast ophthalmic solution) 5% and certain other ophthalmology assets ("Acquisition") on a Current Report on Form 8-K and on its SEDAR+ () profile. In connection with the Acquisition, as previously disclosed, Bausch + Lomb anticipates incurring indebtedness (expected to be comprised principally of an incremental term loan and the issuance of senior secured notes), which is discussed in further detail in its Current Report on Form 8-K. Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario with corporate offices in Bridgewater, New Jersey. Johnson & Johnson (NYSE: JNJ) recently announced updates to its financials and 2023 guidance which reflect its operations as a company focused on transformational innovation in Pharmaceutical and MedTech. The Company has published a recorded webinar for investors to provide additional context behind the updated financials and 2023 guidance. "The completion of this transaction uniquely positions Johnson & Johnson as a Pharmaceutical and MedTech company focused on delivering transformative healthcare solutions to patients," said Joaquin Duato, Chairman of the Board and Chief Executive Officer. "We are incredibly proud of the focus and dedication of our employees worldwide to achieve this milestone, which we are confident will unlock near- and long-term value for all of our stakeholders." Roche (OTCQX: RHHBY) and Alnylam recently announced that the Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT), met the primary endpoint. Zilebesiran demonstrated a clinically significant reduction in 24-hour mean systolic blood pressure (SBP) at month three, achieving a placebo-subtracted reduction greater than 15 mmHg with both 300 and 600 mg doses (p < 0.0001). The study also met key secondary endpoints showing consistent and sustained reductions of SBP at six months supporting quarterly or biannual dosing. In addition, the study showed that zilebesiran was associated with a potent and durable reduction of serum AGT levels through month six while demonstrating an encouraging safety and tolerability profile. "These early results indicate the potential for zilebesiran to achieve sustained blood pressure reduction with quarterly or biannual dosing," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "Also, these data underscore the potential of this investigational medicine to provide transformative impact for many people living with uncontrolled hypertension.'' The Phase 2 trial KARDIA-1 is a randomized, double-blind, placebo-controlled, multi-centre global dose-ranging study designed to evaluate the efficacy and safety of zilebesiran as monotherapy in adults with mild-to-moderate hypertension. The study enrolled 394 adults representing a diverse patient population with untreated hypertension or who were on stable therapy with one or more anti-hypertensive medications (after a washout period). DISCLAIMER: FN Media Group LLC (FNM), which owns and operates FinancialNewsMedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. 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FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE. This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". 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Akosua Mireku @AkosuaMireku1 CyclASol is an eye drop solution for dry eye disease. Credit: Andrii Borodai via Getty Images. The European Medicines Agency (EMA) accepted Novaliq’s marketing authorisation application for CyclASol (cyclosporine ophthalmic solution) 0.1% as a treatment for dry eye disease (DED) . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the MAA, using the centralised procedure for all 27 member states of the European Union. Recommended Reports Reports LOA and PTSR Model - Progesterone in Keratoconjunctivitis Sicca (Dry Eye) GlobalData Reports LOA and PTSR Model - Timbetasin Acetate in Keratoconjunctivitis Sicca (Dry Eye) GlobalData View all Companies Intelligence Harrow Health Inc Novaliq GmbH MAA Co Ltd DED Limited C H M P INC View all In order to determine the drug’s approval chances, the CHMP will evaluate results from six clinical trials in CyclASol’s clinical development programme. This includes results from the Phase III ESSENCE-2 trial (NCT04523129) that showed that the eye drops had a good tolerability profile, with a clinically meaningful effect on 71.6% of participants in the cyclosporine group. Germany-headquartered Novaliq received regulatory approval for CyclASol from the US Food and Drug Administration (FDA) as a DED treatment on 30 May. Marketed under the US brand name, Vevye, the drug became the first and only cyclosporine solution approved for the condition with efficacy demonstrated after four weeks of treatment. In the US and Canada, Harrow Health holds the rights to commercialise the DED therapy, as per a July 2023 deal . CyclASol’s mechanism of action works through the binding of cyclosporine to cyclophilin. This complex suppresses a pathological immune response, which prevents ocular inflammation—a major cause of dry eye disease in many patients. The therapy uses Novaliq’s EyeSol technology to avoid the need for water-based excipients. The biotech lists the benefits of this approach as increasing the drug’s bioavailability and providing a longer residual time on the eye amongst other things. Novaliq’s pipeline currently consists of five DED products and seven candidates for other ophthalmologic conditions. The company is also pursuing research for dermatological treatments through a separate entity Dermaliq. The dermatology clinical programme is currently investigating three drug candidates for androgenetic alopecia, psoriasis, and bacterial skin infections, using its proprietary hyliQ drug delivery technology. In a press release , Novaliq’s CEO Christian Roesky said: “The acceptance of the EU marketing authorisation application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. “We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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