Oculis Announces First Patient Enrolled in Phase 3 OPTIMIZE Trial of OCS-01 in the Treatment of Inflammation and Pain Following Cataract Surgery

LAUSANNE, Switzerland, Jun 29, 2022 - (ACN Newswire via SEAPRWire.com) - Oculis S.A., (Oculis) a global ophthalmology company developing life-changing treatments to save sight and improve eye care with breakthrough innovations, today announced that the first patient has been enrolled in its Phase 3 OPTIMIZE (Once-daily Post ocular surgery Treatment for InflaMmation and paIn to minimiZE drops) trial evaluating the efficacy and safety of once-daily OCS-01, a novel, high concentration, preservative-free, topical OPTIREACH formulation of dexamethasone for the treatment of inflammation and pain following cataract surgery.In the completed Phase 2 SKYGGN study, once-daily OCS-01 successfully met its primary endpoint demonstrating superior efficacy and safety vs vehicle (placebo) in the treatment of inflammation and pain following cataract surgery. Positive data from that trial was presented at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Annual Meeting. Oculis subsequently held a positive end-of-Phase 2 meeting with U.S. FDA which enabled the start of the Phase 3 OPTIMIZE trial. OPTIMIZE is a randomized, double-blind, placebo-controlled Phase 3 trial in 25 participating sites across the US and is scheduled to enroll approximately 240 patients. Efficacy measures of the trial include the absence of anterior chamber cells at Day 15 and absence of pain at Day 4. Treatment of inflammation and pain following ocular surgery is another indication being pursued for OCS-01, following the commencement in November 2021 of the Phase 3 DIAMOND trial investigating OCS-01 in patients with DME.Eric Donnenfeld, M.D. clinical professor of ophthalmology at New York University and Trustee of Dartmouth Medical School, said: "Following cataract surgery, patients often need to self-administer eye drops several times a day to manage inflammation and pain. An efficacious, preservative-free alternative, administered just once a day could provide significant advantages over current options." Riad Sherif, M.D., CEO of Oculis, said: "This is another important development milestone for OCS-01, following the start of our Phase 3 trial in DME last year, which further signals the potential for this novel product candidate to address the limitations of currently available treatments for both retinal and front-of-the-eye indications. Clinical data generated so far have been very encouraging and we look forward to generating further data in this trial to support regulatory submissions."OCS-01 has been developed using Oculis's OPTIREACH solubilizing nanoparticle technology, a proprietary platform that enables the formulation of drugs as non-invasive topical eyedrop treatments, a longer residence time on the eye surface and enhances their bioavailability in the relevant eye tissues, particularly the retina.About OculisOculis is a global biopharmaceutical company purposefully driven to save sight, improve eye care and address significant unmet medical needs with breakthrough innovations. Oculis's highly differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments. With a presence in key international markets, Oculis is poised to deliver life-changing treatments to patients worldwide. Headquartered in Lausanne, Switzerland and with operations in Europe, the U.S. and China, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: www.oculis.com Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

New treatment for severe corneal inflammation from DED now listed on PBS

MELBOURNE, Oct 1, 2021 - (ACN Newswire via SEAPRWire.com) - Today, adults living with severe corneal inflammation from DED (dry eye disease) gain access to a new treatment on the PBS. Ikervis(R), Australia's first PBS listed disease-modifying ciclosporin eye drop treatment for severe keratitis in adults with DED, is now available (1 October 2021).In-licensed for the first time in Australia by Seqirus, a wholly-owned subsidiary of CSL, from leading ophthalmic company Santen Pharmaceutical Co Ltd, Ikervis contains the disease-modifying treatment ciclosporin, used to reduce inflammation associated with severe keratitis in DED.According to Professor Stephanie Watson, Ophthalmologist, Clinician Scientist, Ophthalmic Surgeon and Chair of the Ophthalmic Research Institute of Australia, the COVID-19 pandemic is exacerbating DED cases due to increased mask use and screen time."We have seen a marked increase in dry eye symptoms among mask users. Typically, DED affects women more than men. According to a US study, women are almost three times more likely to develop DED than men and often progress to more severe forms of the disease earlier than men," said Prof. Watson."Keratitis, a condition involving inflammation of the cornea, can be a complication for some patients with DED. Patients with severe keratitis from DED typically present with eye surface damage and inflammation that can sometimes feel like an irritating, itchy or burning sensation with possible blurry vision."Patients with severe inflammation of the cornea from DED are often managed with a number of different treatment options, which can be costly for a condition that requires ongoing management. A new subsidised treatment option will improve access for these patients," Prof. Watson said. "Severe inflammation of the cornea from DED is complicated by a difficult cycle involving inflammation of the eye and damage to the eye surface. Treatment options targeting the immune system are therefore needed to manage these complications from DED, and break the cycle of inflammation," said Dr Margaret Lam, Optometrist, Head of Professional Services at George and Matilda Eyecare and Adjunct Senior Lecturer at the School of Optometry & Vision Science, UNSW."Artificial tears aim to provide symptom relief for DED, but don't address the underlying cause of severe corneal inflammation. In these cases, inflammation-reducing treatment options are required. Today's PBS listing of another treatment option for severe keratitis in adults with DED is therefore welcome news for ophthalmologists, optometrists and patients alike," Dr Lam said.Executive Chair of The B Team Australasia, Lynette has spent the past 16 years living with severe corneal inflammation from DED. Soon after undergoing cataract surgery on both of her eyes in 2005, her eyes became extremely irritated, and she developed double vision. Little did she know at the time, her cataract surgery, coupled with a delayed diagnosis and her advancing age, would result in developing severe corneal inflammation from DED."I'm often unable to see things. For instance, I have to carry a magnifying glass when my eyes get blurry, or I develop double vision. Even at the supermarket, I have to carry a magnifying glass to read the food," said Lynette. "When people ask me to look at something for them at work, whether it is a document, or on-screen, depending on the health of my eyes at the time, I find it really difficult."Lynette maintains it is important for Australian adults living with severe corneal inflammation from DED to have timely access to a range of treatment options. "Had my eye disease been detected earlier, it may not have had such an impact on my life," Lynette said.Seqirus Head of Medical Affairs for the International Region, Dr Jonathan Anderson, Melbourne, said Seqirus is excited to be introducing the company's second PBS listed treatment option to the eye care market this year. "Seqirus is committed to broadening access to eye care products to help address unmet clinical needs," said Dr Anderson. "Today's PBS listing of Ikervis for severe keratitis in adults with DED will give Australians access to another treatment option that has long been available overseas."About Ikervis TGA approved in December 2020, Ikervis is a Schedule 4 (S4): Prescription Only Medicine. Ikervis is listed on the PBS from 1 October 2021 for severe keratitis in DED, for prescription by an optometrist or ophthalmologist and requires Authority Approval.About Seqirus Seqirus, a CSL company, is a leading provider of essential vaccines and pharmaceuticals. Having served Australia's healthcare needs for over a century, today we operate Australia's only local manufacturing facility for seasonal and pandemic influenza vaccines. Seqirus produces unique medicines in the National Interest, and also in licences a broad range of paediatric and adult vaccines and specialty pharmaceutical products. Visit www.seqirus.com.Mel Kheradi, VIVA! Communications, m: 0421 551 257, e: melorin@vivacommunications.com.auReferences:1. Ikervis Approved Product Information.2. The Pharmaceutical Benefits Scheme (PBS). Medicine Status - Ciclosporin. 2021 September 2021]; Available from: https://www.pbs.gov.au/medicinestatus/document/498.html.3. Krolo, I., et al., Mask-Associated Dry Eye During COVID-19 Pandemic-How Face Masks Contribute to Dry Eye Disease Symptoms. Med Arch, 2021. 75(2): p. 144-148.4. Barabino, S., A Narrative Review of Current Understanding and Classification of Dry Eye Disease with New Insights on the Impact of Dry Eye during the COVID-19 Pandemic. Ophthalmol Ther, 2021. 10(3): p. 495-507.5. Amrane, M., et al., Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease - a randomised comparative study. J Fr Ophtalmol, 2014. 37(8): p. 589-98.6. Leonardi, A., B. Flamion, and C. Baudouin, Keratitis in Dry Eye Disease and Topical Ciclosporin A. Ocular Immunology and Inflammation, 2017. 25(4): p. 577-586.7. Baudouin, C., et al., A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye. Eur J Ophthalmol, 2017. 27(5): p. 520-530.8. Stapleton, F., et al., TFOS DEWS II Epidemiology Report. The Ocular Surface, 2017. 15(3): p. 334-365. Copyright 2021 ACN Newswire. All rights reserved. (via SEAPRWire)

Heart inflammation after Covid-19 jabs: What does it mean for you?

SINGAPORE - Rare cases of heart inflammation have been reported with Covid-19 vaccines that use mRNA technology - namely the Pfizer-BioNTech and Moderna jabs, both overseas and locally. The Straits Times finds out the answers to some questions. Q: What is it? A: Myocarditis is caused by the inflammation of the heart muscle while pericarditis is the inflammation of the outer lining of the heart. It is often caused by a viral infection but can also be the result of certain chemicals or allergic reactions to medications, autoimmune diseases and other kinds of infections, including by bacteria and parasites. Myocarditis and pericarditis are not heart attacks, which are usually caused by blockages in the blood vessels that supply the heart. Q: Are these conditions common? A. The exact prevalence in Singapore is not known. This is because the severity of symptoms varies substantially - some people have no symptoms while others may have only mild symptoms - and so it is often not detected. In most cases, the inflammation is mild, but it can be severe enough to require hospitalisation and even cause death. Singapore's Health Sciences Authority (HSA) said in an update that as at June 30, in general, five to seven individuals per 100,000 people a year are hospitalised for myocarditis or pericarditis. This makes up roughly 280 to 400 cases a year. Q: Is there a link between heart inflammation and the mRNA vaccine? A: These cases in adolescents and young adults are "likely linked" to the mRNA vaccines, a group of doctors advising the United States Centres for Disease Control and Prevention said on June 23. People generally recover from the symptoms and do well. Inflammation of the heart was also reported in some Covid-19 patients last year, most likely the result of an overactive immune system giving rise to the inflammation. As mRNA vaccines lead to a similar, but milder, immune response, this could also result in inflammation. Q: How many people suffer from heart inflammation after getting the mRNA vaccines? A: As at June 30, HSA has received 12 reports of myocarditis and pericarditis after close to 5.5 million doses of vaccines administered. Five of the cases occurred in adults aged 30 and above, two of whom were women. Seven of the cases involved males aged below 30. More on this topic   Related Story US FDA to add warning about rare heart inflammation to Pfizer, Moderna Covid-19 vaccines   Related Story 4 young men in S'pore had heart inflammation after Covid-19 jabs Six of the cases occurred after the first dose, said HSA. Most were reported to have occurred within a week of the individual receiving the vaccine. HSA also noted that a greater frequency of heart attacks and strokes was not observed in vaccinated people here. In the US, more than 1,200 cases of heart inflammation have been reported as at June 2021 and most were mild cases. It is estimated that there are just 12.6 heart inflammation cases per million second doses administered. Q: How do I know if I have myocarditis? A: The typical symptoms are chest pain, shortness of breath and a rapid pulse. Symptoms may also be non-specific, ranging from tiredness, muscle aches and a mild fever. The patient may also feel shortness of breath occurring more readily than before, wrote Dr Mak Koon-Hou, a cardiologist at Gleneagles Medical Centre, in his 2015 book Understanding And Preventing Sudden Death. Q: What happens after myocarditis? A: Generally, most patients respond well to treatment and recover. The patient is usually treated symptomatically and closely monitored for abnormal heart rhythms and heart failure. Physical exertion is believed to increase the risk of sudden death, Dr Mak wrote. More on this topic   Related Story Cause of cardiac arrest for 16-year-old who got Covid-19 vaccine still being investigated   Related Story Coronavirus microsite: Get latest updates, videos and graphics When a person exercises, the demand on the heart increases. If the heart muscle is already inflamed, strenuous physical activity may worsen the amount of damage to the heart muscle, adversely affecting its function. Sporting activities should be avoided until the condition is completely resolved and medical treatment should be given prior to resumption of exercise.   Related Stories:  Related Story Thailand's full reopening in doubt with 10-fold surge in Covid-19 Related Story Free disposable masks, mouth spray from Temasek Foundation after Singapore's National Day Related Story Cause of cardiac arrest for 16-year-old who got Covid-19 vaccine still being investigated Related Story Covid-19 curbs in Seoul may be raised to highest level as new cases surge Related Story New Covid-19 cluster in S'pore with 4 cases Related Story S'pore's Covid-19 rules from July 12: 9 things you need to know Related Story Indonesian doctors face tough choice of who will live or die at overrun Covid-19 hospitals