Eye Infections

ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps Clinical trial program also showed reduction in sinus inflammation and in acute exacerbations, which frequently result in use of antibiotics XHANCE uses the proprietary Exhalation Delivery System to enable deposition of a proven steroid in target areas of inflammation deep in the nose not typically reached by standard nasal sprays Chronic sinusitis affects approximately 30 million adults in the U.S. YARDLEY, Pa., March 15, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the U.S. Food and Drug Administration (FDA) has approved XHANCE® (fluticasone propionate) nasal spray for the treatment of chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. Chronic sinusitis (also called “chronic rhinosinusitis” or “CRS”) is one of the most common chronic diseases, affecting approximately 30 million adults in the United States. Research shows that the disease impairs quality of life to a similar degree as other serious chronic conditions, such as chronic obstructive pulmonary disease, sciatica, or migraine. Chronic sinusitis is also one of the most common diagnoses in adult outpatient medicine. Chronic sinusitis is diagnosed in approximately 10 million outpatient visits, of which approximately 70% result in antibiotic prescriptions, and leads to more than 600,000 surgeries annually. Although there are FDA–approved medications to treat nasal polyps, including XHANCE, no medication had ever been approved for the more than two-thirds of chronic sinusitis patients who do not have nasal polyps – until today.1 “The FDA approval of XHANCE for the treatment of CRS without nasal polyps is an important milestone,” said Rick Chandra, M.D., Professor of Otolaryngology-Head and Neck Surgery, Endowed Director, Roland “Ron” Eavey, MD, SM Endowed Directorship in Leadership and Education, Service Chief, Rhinology and Skull Base Surgery, Vanderbilt University. “Until today, we have been forced to use unproven therapies to try and alleviate the symptoms that these patients suffer. While we often resort to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies. XHANCE, which uses the Exhalation Delivery System to enable delivery of an established topical steroid to the areas of the nasal cavity and sinuses we know to be extensively inflamed, is now proven to be effective in treating our CRS patients both with and without nasal polyps.” “People who don’t suffer from chronic sinusitis may not appreciate how burdensome the condition can be. More than 80% of patients with chronic sinusitis report frustration with symptom relief when using a standard-delivery nasal steroid sprays, and patients commonly use multiple unproven over the counter medications in an effort to find symptom relief.” said Ramy Mahmoud, MD, MPH, CEO of Optinose. “Although chronic sinusitis is one of the most common diagnoses in outpatient physician visits, and surgery is available, there has never been a prescription medication approved by the FDA as safe and effective to treat the millions of patients without nasal polyps suffering from this debilitating disease. We are thrilled to now be able to offer new hope to these patients and believe XHANCE has the potential to become part of the standard of care for the treatment of chronic sinusitis.” The approval was based on data from the ReOpen program evaluating XHANCE for treatment of adults with chronic sinusitis. A drug-device combination product, XHANCE uniquely combines a widely used nasal steroid with the Exhalation Delivery System™, an innovative delivery system designed to target the sites where inflammation occurs, especially difficult-to-access sinuses and sinonasal drainage tracts not typically reached by standard-delivery nasal sprays. The safety pro tolerability of XHANCE for patients in the ReOpen trials was generally consistent with its currently labeled safety profile. The most common adverse reactions (incidence ≥ 3%) in the ReOpen program were epistaxis, headache, and nasopharyngitis. About Optinose Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit or follow us on X and LinkedIn. About XHANCE XHANCE® is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for the treatment of chronic rhinosinusitis (with and without nasal polyps) in patients 18 years of age or older. About the ReOpen Program The ReOpen program comprised two global, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and safety of one or two sprays of XHANCE in each nostril twice daily, over 24 weeks, in patients suffering from chronic sinusitis. In ReOpen1, the first of the two trials, 332 chronic sinusitis patients either with or without concurrent nasal polyps were treated. In ReOpen2, 222 chronic sinusitis patients who did not have polyps in the nasal cavity were treated. The co-primary endpoints were change from baseline in symptoms, as measured by composite symptom score (nasal congestion, facial pain or pressure, and nasal discharge) at the end of week 4, and change in inflammation inside the sinus cavities, as measured by CT scans (change in the average of the percentages of volume occupied by disease in the ethmoid and maxillary sinuses) at week 24. The ReOpen trial program is a landmark research program that included the first ever large, placebo-controlled trials we are aware of to demonstrate that any nasal medication produces significant improvement in both symptoms and inflammation inside the sinuses for patients with chronic sinusitis, regardless of whether or not nasal polyps are present, and to show reduction in the number of acute exacerbations.1 IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE. WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma until healing has occurred. Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur. Immunosuppression and infections can occur, including potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly. Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis. Chronic rhinosinusitis with nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis. DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects. USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure. Please see full Prescribing Information, including Instructions for Use References James N. Palmer, Nithin D. Adappa, Rakesh K. Chandra, Greg E. Davis, Mahboobeh Mahdavinia, John Messina, Randall A. Ow, Zara M. Patel, Anju T. Peters, Harry Sacks, Rodney J. Schlosser, Raj Sindwani, Zachary M. Soler, Andrew A. White, Sarah K. Wise, Ramy A. Mahmoud, Efficacy of EDS-FLU for Chronic Rhinosinusitis: Two Randomized Controlled Trials (ReOpen1 and ReOpen2), The Journal of Allergy and Clinical Immunology: In Practice, 2024,, ISSN 2213-2198, ( ) Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the benefits of XHANCE for the treatment of chronic sinusitis (also called chronic rhinosinusitis) with and without nasal polyps; the benefits of the approval of XHANCE for the treatment of chronic rhinosinusitis without nasal polyps; the potential for XHANCE to become part of the standard of care for the treatment of chronic sinusitis; the benefits of the Exhalation Delivery System; and other statements regarding the Company's future operations, prospects, objectives, and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: physician and patient acceptance of XHANCE for its new indication (treatment of adults with chronic rhinosinusitis without nasal polyps); the Company’s ability to maintain adequate third party reimbursement for XHANCE (including its new indication); potential for varying interpretation of clinical trial results of XHANCE for the treatment of chronic sinusitis; ; the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than the Company expects; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in our most recent Form 10-K and Form 10-Q filings with the Securities and Exchange Commission - which are available at . As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise. Optinose Investor Contact Jonathan Neely jonathan.neely@optinose.com 267.521.0531

Retrospective analysis suggests Acthar Gel treatment was associated with similar improvement in health status and overall symptom reduction in African Americans and non-African Americans with symptomatic sarcoidosis1 Findings on treatment response and physician-reported outcomes indicate that Acthar Gel may be a viable treatment option for both African American and non-African American sarcoidosis patients1 DUBLIN, March 11, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the publication of findings from a retrospective chart review of Acthar® Gel (repository corticotropin injection) treatment outcomes for African American and non-African American patients with symptomatic sarcoidosis – including treatment patterns, co-medication use, and overall health outcomes.1 This analysis suggested that Acthar Gel treatment was associated with similar improvements in health outcomes, a reduction in symptoms, and reduced co-medication use in both African Americans and non-African Americans with symptomatic sarcoidosis.1 The manuscript was recently published online in Therapeutics & Clinical Risk Management. This research builds upon findings from a study investigating the clinical and real-world outcomes of Acthar Gel treatment in a subgroup of African Americans with symptomatic sarcoidosis, previously presented at the 2022 American Thoracic Society Annual International Conference in San Francisco, CA, and published in Therapeutic Advances in Respiratory Disease in 2019.2 Acthar is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.3 Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several autoimmune disorders and medical conditions known to cause inflammation, including symptomatic sarcoidosis.3 Please see additional indications and Important Safety Information below. "The results of this retrospective medical chart review highlight unmet needs that exist for African American patients with symptomatic sarcoidosis, who are disproportionately affected by the disease, and reinforce Acthar Gel's potential to help improve health outcomes for appropriate patients,"1,4,5 said George Wan, Ph.D., M.P.H., Vice President, Evidence Generation and Data Sciences, Mallinckrodt. "This research reflects Mallinckrodt's commitment to collecting real-world data on the relationship between patient characteristics, treatment patterns, and outcomes to support clinicians' treatment decisions and address disparities in symptomatic sarcoidosis care."1 About the Study:1 In this retrospective analysis, a national database of Acthar Gel prescribers and the American Medical Association Physician Master were merged to obtain a sample of 98 physicians to provide data on the last 6 consecutive patients seen who met the study's eligibility criteria. The medical records were extracted for adult patients (≥18 years) with a diagnosis of advanced symptomatic sarcoidosis, who had ≥1 symptom, and who had either completed at least one course of Acthar Gel or had received Acthar Gel for at least 6 months during data collection. A total of 272 patients with symptomatic sarcoidosis were included in this analysis (African American (AA): n=168; non-African American (non-AA): n=104). Most patients in both race groups were diagnosed with stage 3 or 4 sarcoidosis based on chest imaging and biopsy (AA: 61.3%, n=103 vs. non-AA: 68.3%, n=71; p=0.2453). Per an assessment of patient characteristics and Acthar Gel treatment patterns, this analysis suggests that the average time since the first diagnosis of sarcoidosis was slightly longer among AA than non-AA (mean ± SD: 5.2 ± 7.6 years vs. 4.3 ± 5.1 years; p>0.05).1 Further, a lower proportion of AA vs. non-AA had completed a course of Acthar Gel therapy (44%, n=74 vs. 55.8%, n=58; p=0.0602) during the data collection period,1 and the duration of Acthar Gel treatment was slightly longer among AA vs. non-AA (mean ± SD: 31.7 ± 32 vs. 29 ± 27.4 weeks; p>0.05).1 "This research underscores the importance of conducting real-world studies to provide data that helps to recognize the disparities in symptomatic sarcoidosis care and address unmet needs to better support health outcomes for all appropriate patients," said Mary McGowan, Chief Executive Officer, Foundation for Sarcoidosis Research (FSR). FSR is the leading international organization dedicated to finding a cure for sarcoidosis and improving care for sarcoidosis patients through research, education, and support. Key Findings: Co-Medication Utilization Patterns1 Significantly fewer patients among both race groups were on any co-medication after Acthar Gel initiation (p<0.0001): AA before: 88.1%, n=148 vs. after: 20.2%, n=34 Non-AA before: 83.7%, n=87 vs. after: 24%, n=25 More AA had a reduction in any co-medication use after Acthar Gel initiation (AA: -77% vs. non-AA: -71%; p<0.0001). After Acthar Gel initiation, fewer AA (before: 59.5%, n=100 vs. after: 11.9%, n=20; p<0.0001) and non-AA (before: 65.4%, n=68 vs. after: 14.4%, n=15; p<0.0001) were on glucocorticoids. Overall, the mean prednisone dose reduced after Acthar Gel initiation among AA (before: 18.5 mg/day vs. after: 10.1 mg/day) and non-AA (before: 17.6 mg/day vs. after: 10 mg/day). The proportion of patients on prednisone daily dose of <10 mg increased after Acthar Gel initiation among both race groups (AA before: 27.8%, n=27/97 vs. after: 31.6%, n=6/19; non-AA before: 13.6%, n=9/66 vs. after: 60%, n=9/15). Physicians' Assessment of Improvement1 The health status of 95.2% (n=160) of AA and 97.1% (n=101) of non-AA improved following treatment with Acthar Gel, based on physician-provided assessments of patient outcomes. Treatment response to overall symptoms was not statistically significantly different between both race groups (AA: 72.6%, n=122 vs. non-AA: 70.2%, n=73) The most frequently reported changes in symptoms following Acthar Gel treatment in both race groups were: Reduction in inflammation (AA: 33.9%, n=57 vs. non-AA: 32.7%, n=34) Improvement in quality of life (AA: 31.5%, n=53 vs. non-AA: 34.6%, n=36) Improvement in lung function (AA: 30.4%, n=51 vs. non-AA: 53.8%, n=56; p<0.05) Reduction in fatigue (AA: 27.4%, n=46 vs. non-AA: 35.6%, n=37) Limitations:1 Data retrospectively collected from medical charts of patients may have omissions and errors. Completeness of information was assessed to the extent possible to minimize bias resulting from any missing data. In addition, only data available in medical charts or known to be complete to the respondents were extracted. Additional limitations of this study include: Physicians' standards for the interpretation of change in each patient's health status vary which may result in bias due to over- or under-estimation of the effectiveness of Acthar Gel. This study was unable to quantify clinical data such as diagnostic and safety measures, clinical and sustained response after treatment, and reasons for discontinuation or dose adjustments related to Acthar Gel. Due to the exploratory nature of this analysis, data were not collected for other medications besides Acthar Gel. Data on adverse reactions in this population, drivers of the decision to use Acthar Gel, and detailed information on prior therapies were not captured. This study was sponsored by Mallinckrodt Pharmaceuticals. INDICATIONS Acthar Gel is indicated for: Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation Symptomatic sarcoidosis Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis) Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis IMPORTANT SAFETY INFORMATION Contraindications Acthar is contraindicated: For intravenous administration In infants under 2 years of age who have suspected congenital infections With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin Warnings and Precautions The adverse effects of Acthar are related primarily to its steroidogenic effects Acthar may increase susceptibility to new infection or reactivation of latent infections Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment Cushing's syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy Adverse Reactions Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve Pregnancy Acthar may cause fetal harm when administered to a pregnant woman Please see full Prescribing Information for additional Important Safety Information. ABOUT SYMPTOMATIC SARCOIDOSIS Sarcoidosis is a challenging and rare multisystem disease.6 In some cases, the symptoms may come and go throughout a lifetime.6 This is referred to as symptomatic sarcoidosis.6 In people with sarcoidosis, the immune system overreacts, forming clumps of cells called granulomas that result in inflammation to the body's tissues.7 The disease can impact any organ, but it most often impacts the lungs, lymph nodes, eyes, liver, and skin.8 Nearly 90 percent of people with sarcoidosis will suffer lung problems.8 Concomitant involvement of organs outside of the lungs is common, occurring in more than half of all sarcoidosis cases, according to one study.2 ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to Acthar® Gel, its potential to improve health and treatment outcomes, its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with Acthar Gel; and other risks identified and described in more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 mediainquiries@grcomms.com Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 derek.belz@mnk.com Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400042 03/24 References ___________________________________ 1 Bindra J, et al. Acthar Gel in African Americans versus Non-African Americans with Symptomatic Sarcoidosis: Physician Assessment of Patient Medical Records. Ther Clin Risk Manag. 2024;20:83-94 . 2Chopra I, et al. Repository Corticotropin Injection in Patients with Advanced Symptomatic Sarcoidosis: Retrospective Analysis of Medical Records. Ther Adv Res Dis. 2019(13);1-11. DOI: 10.1177/1753466619888127. 3 Acthar® Gel (repository corticotropin injection) [prescribing information]. Mallinckrodt ARD LLC. 2023. 4 Judson MA. Pulmonary Sarcoidosis: A Guide for the Practicing Clinician. Humana Press, New York, NY. 2014. 8;149-186. 5 Hena, K. M. Sarcoidosis Epidemiology: Race Matters. Front Immunol. 2020;11:1-5. 6 Sarcoidosis. American College of Chest Physicians. Available at: . Accessed February 2024. 7 Sarcoidosis Overview. 2019. Cleveland Clinic. Available at: . Accessed February 2024. 8 Judson MA, Boan AD, Lackland DT. The Clinical Course of Sarcoidosis: Presentation, Diagnosis, and Treatment in a Large White and Black Cohort in the United States. Sarcoidosis Vasc Diffuse Lung Dis. 2012. 29(2);119-127. View original content to download multimedia: SOURCE Mallinckrodt plc Company Codes: NYSE:MNK, OTC-BB:MCKPF, OTC-BB:MNKPF, OTC-PINK:MCKPF

WALTHAM, Mass., March 11, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that leading retina specialist Philip Ferrone, M.D., will join the company as Chief Medical Retina Advisor, effective March 18. “Phil is globally renowned for his leadership in retina, including as a past president of the American Society of Retina Specialists (ASRS), so we are delighted to welcome him to the Apellis team,” said Caroline Baumal, M.D., Chief Medical Officer, Apellis. “Phil has extensive expertise in retina research and patient care, which will be invaluable as we continue to bring SYFOVRE to patients with GA and advance our retina pipeline.” “It is an honor to join Apellis in its mission to deliver life-changing treatments for patients living with serious diseases,” said Dr. Ferrone. “I was an early adopter of SYFOVRE and have realized first-hand how impactful this treatment is for GA patients. I look forward to working closely with Caroline and this tremendously talented team to advance care for patients with this devastating disease.” Dr. Ferrone will continue to serve as the director of clinical research at Vitreoretinal Consultants in New York. He is a past president of the ASRS and has been on its board of directors for 18 years. He is also a past president of The Foundation of the ASRS, which aims to raise patient awareness and education about retina health. Dr. Ferrone has served as principal investigator in over 60 clinical trials investigating new treatments for retinal diseases, authored over 75 peer-reviewed medical manuscripts, six book chapters, and has given over 160 scientific presentations at national and international ophthalmology medical meetings. Dr. Ferrone earned his undergraduate degree from Union College and his medical degree from Harvard Medical School. He completed a fellowship in vitreoretinal disease and surgery at Associated Retinal Consultants in Royal Oak, MI and was Chief Resident and on faculty at the Duke University Eye Center. About SYFOVRE® (pegcetacoplan injection) SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration. U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection) CONTRAINDICATIONS SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. Neovascular AMD In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. Intraocular Inflammation In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Increased Intraocular Pressure Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. Please see accompanying full Prescribing Information for more information. About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit or follow us on Twitter and LinkedIn. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contact: Lissa Pavluk media@apellis.com 617.977.6764 Investor Contact: Meredith Kaya meredith.kaya@apellis.com 617.599.8178