Brepocitinib

YUTIQ addresses a significant unmet need in the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The uveitis treatment market is projected to grow steadily, driven by rising incidence and improved diagnosis, positioning YUTIQ for strong market adoption. LAS VEGAS, May 6, 2025 /PRNewswire/ -- DelveInsight's " YUTIQ Market Size, Forecast, and Market Insight Report" highlights the details around YUTIQ, a sterile non-biodegradable intravitreal implant with 0.18 mg FA (fluocinolone acetonide). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of YUTIQ. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Alimera Sciences/EyePoint Pharma's YUTIQ (fluocinolone acetonide) Overview YUTIQ is a sterile, non-biodegradable intravitreal implant containing 0.18 mg of fluocinolone acetonide (FA). It provides a sustained drug release at an initial rate of 0.25 µg per day over 36 months. This corticosteroid-based therapy is indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. The implant is preloaded in a single-use applicator for direct injection into the vitreous cavity. It received FDA approval in October 2018 and was commercially launched in the U.S. in February 2019. YUTIQ was developed to enhance the performance of RETISERT by delivering a lower corticosteroid dose to the retina, thereby reducing the incidence of adverse effects such as increased intraocular pressure (IOP) and cataract formation. Its extended duration of action also minimizes the need for frequent dosing, improving patient convenience and treatment tolerability. Learn more about YUTIQ projected market size for uveitis @ YUTIQ Market Potential Uveitis is a rare condition characterized by inflammation in part or all of the uvea, the middle layer of the eye that includes the choroid, ciliary body, and iris. This inflammation can also impact other parts of the eye, such as the lens, retina, optic nerve, and vitreous humor. Uveitis represents a broad spectrum of inflammatory eye disorders and may result from trauma, infections, tumors, or autoimmune and inflammatory diseases. According to DelveInsight, there were approximately 1 million diagnosed prevalent cases of uveitis across the 7MM in 2023, with numbers projected to rise between 2020 and 2034. The primary objective of uveitis treatment is to control inflammation quickly, alleviate pain, and prevent vision loss and other complications. Current clinical guidelines stress the importance of early detection and timely intervention. Approved therapies include XIPERE, OZURDEX, HUMIRA, YUTIQ/ILUVIEN, RETISERT, and DUREZOL. The uveitis market in the 7MM was valued at around USD 1.54 billion in 2023, and it is anticipated to grow further by 2034, driven by rising disease prevalence, enhanced understanding of its underlying mechanisms, and ongoing technological advancements. Discover more about the uveitis market in detail @ Uveitis Market Report Emerging Competitors of YUTIQ Prominent players such as Tarsier Pharma with TRS01, Eli Lilly and Company with OLUMIANT (baricitinib), Oculis Pharma with licaminlimab (OCS-02), Priovant Therapeutics with brepocitinib, and others are actively developing therapies for uveitis. In September 2024, Brepocitinib was granted Fast Track Designation (FTD) for NIU by the FDA for the treatment of non-anterior NIU. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. In January 2024, Tarsier Pharma received US FDA agreement under a Special Protocol Assessment (SPA) for the Phase III Tarsier-04 trial protocol and planned statistical analysis for evaluating TRS01 eye drops in treating non-infectious uveitis, including uveitic glaucoma. To know more about the number of competing drugs in development, visit @ YUTIQ Market Positioning Compared to Other Drugs Key Milestones of YUTIQ In May 2023, EyePoint Pharmaceuticals revealed that it has finalized an agreement to sell YUTIQ (fluocinolone acetonide intravitreal implant) 0.18mg to Alimera Sciences, Inc. In July 2019, EyePoint Pharmaceuticals, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) had assigned a permanent and distinct J-code, J7314, under the Healthcare Common Procedure Coding System (HCPCS) for YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg, a three-year micro-insert used for treating chronic, non-infectious uveitis in the posterior segment of the eye. In February 2019, EyePoint Pharmaceuticals announced the commercial launch of YUTIQ in the United States. In October 2018, EyePoint Pharmaceuticals announced that the FDA had approved YUTIQ (fluocinolone acetonide intravitreal implant) to treat chronic non-infectious uveitis affecting the posterior segment of the eye. Discover how YUTIQ is shaping the uveitis treatment landscape @ YUTIQ Injection YUTIQ Market Dynamics YUTIQ, an intravitreal fluocinolone acetonide implant developed by EyePoint Pharmaceuticals, is designed for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The market dynamics for YUTIQ are shaped by several key factors, including the rising prevalence of uveitis globally, the unmet need for long-term treatment options, and YUTIQ's unique positioning as a sustained-release corticosteroid implant that provides up to three years of continuous drug delivery. This extended-release capability differentiates it from other corticosteroid therapies, which often require more frequent injections and carry higher systemic side effect risks. These features have helped YUTIQ carve out a niche, especially among ophthalmologists and retinal specialists managing patients with recurrent or refractory uveitis. However, market penetration for YUTIQ also faces several headwinds. Cost remains a significant barrier, particularly in markets where reimbursement is limited or slow to be adopted. The presence of competing therapies, such as OZURDEX (dexamethasone intravitreal implant) and systemic immunosuppressive treatments, also affects uptake. Furthermore, given the chronic nature of uveitis and the relatively limited patient population, growth is inherently capped by the size of the addressable market. Nonetheless, EyePoint's efforts to expand payer coverage and build stronger relationships with retina specialists continue to support gradual market expansion. Overall, while YUTIQ addresses a critical clinical need, its long-term commercial success will depend on navigating access challenges and differentiating further from both systemic and local therapies. Dive deeper to get more insight into YUTIQ's strengths & weaknesses relative to competitors @ YUTIQ Market Drug Report Table of Contents Related Reports Uveitis Market Uveitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key uveitis companies, including Tarsier Pharma, Oculis Pharma, Roche, Eli Lilly and Company, Acelyrin, Affibody Medical, Eyevensys, Priovant Therapeutics, Inc, Santen Inc., ABIONYX Pharma, OKYO Pharma, among others. Uveitis Pipeline Uveitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key uveitis companies, including Eli Lilly and Company, Santen Inc., Clearside Biomedical, Affibody, Eyevensys, among others. Autoimmune Uveitis Market Autoimmune Uveitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key autoimmune uveitis companies, including Tarsier Pharma, Eli Lilly and Company, Oculis Pharma, Eyevensys, Priovant Therapeutics, Inc., among others. Anterior Uveitis Market Anterior Uveitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key anterior uveitis companies, including Novartis AG, Santen Pharmaceutical Co., Ltd; AbbVie Inc., Eyegate Pharmaceuticals, Inc., Clearside Biomedical, Inc., Aldeyra Therapeutics, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us: Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with 74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with 64% mean IgG reduction) Initial CIDP results from Period 1, following standard of care washout, demonstrate a mean improvement in the adjusted INCAT disability score of 1.8 across batoclimab arms and an 84% responder rate in those patients who achieved an IgG lowering greater than 70% In both batoclimab studies, deeper IgG reductions correlated with better clinical outcomes across a range of assessments and timepoints INDs active for both MG and CIDP with pivotal study initiations for lead asset IMVT-1402 in these indications expected imminently Immunovant and Roivant to host combined investor call to discuss these updates today, March 19, 2025 at 8 a.m. EDT NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported topline results from its Phase 3 study of batoclimab in MG and initial results from Period 1 of its Phase 2b study in CIDP. “We are excited to share positive results from our MG and CIDP studies. While neurologists and patients are very enthusiastic about currently approved FcRn inhibitors, they tell us that they also see a lot of potential for a next-generation FcRn inhibitor that can offer deeper and more durable responses for patients whose disease is still affecting their daily function. Today’s results show that deeper IgG reduction leads to deeper responses in MG and CIDP. Beyond the results in MG and CIDP, we believe that our core thesis - that deeper IgG reduction, at the levels achieved by high dose batoclimab and high dose IMVT-1402, leads to improved clinical outcomes - will apply to a wide range of auto-antibody mediated conditions,” said Pete Salzmann, M.D., chief executive officer of Immunovant. About the Phase 3 Study in MG The Phase 3 study in MG is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adults with MG. Following screening, participants with moderate to severe MG were randomized into Period 1 where they received high dose batoclimab (680mg weekly) or lower dose batoclimab (340mg weekly) or placebo for 12 weeks. Responders to batoclimab in Period 1, defined as ≥2-point improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline, were re-randomized 1:1:1 to batoclimab (340mg weekly or 340mg every other week) or placebo for 12 weeks (Period 2). The primary endpoint of the study was mean change from baseline in MG-ADL in acetylcholine receptor antibody positive (AChR+) participants at Week 12 (end of Period 1). About the Phase 2b Study in CIDP The Phase 2b study in CIDP is a randomized, quadruple-blind, placebo-controlled study designed to assess the efficacy and safety of batoclimab in adult participants with active CIDP. Similar to other recent studies, this Phase 2b study in CIDP begins with a non-placebo controlled run-in (Period 1), during which participants whose disease had worsened during standard of care washout then receive either 340 mg or 680 mg batoclimab weekly by subcutaneous injection. Participants who respond to batoclimab therapy in Period 1 (responders are defined as those achieving a ≥1 point improvement from Period 1 baseline in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score), are then randomized 1:1 to receive either 340 mg batoclimab or placebo weekly in a 24-week withdrawal period (Period 2). The primary endpoint will assess the percentage of participants who remain relapse-free at Week 36, at the end of Period 2. The study is ongoing and has not yet been unblinded. Therefore, pooled data are currently available from Period 1 and no data are available for the primary endpoint at the end of Period 2. Phase 3 MG Study Results Highlights In the Phase 3 MG study, batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants. Participants entering the study and randomized to 680mg of batoclimab given weekly by subcutaneous injection achieved a 5.6 point improvement in MG-ADL at Week 12, while those randomized to 340mg of batoclimab given weekly by subcutaneous injection achieved a 4.7 point improvement in MG-ADL at Week 12 and those randomized to placebo experienced a 3.6 point improvement in MG-ADL at Week 12. Large differences between the dosing arms were observed, especially for deeper response thresholds. Results in Period 2 (Weeks 12-24) were as expected, with patients re-randomized to 340mg weekly outperforming those whose dose was reduced. Additional efficacy results are summarized in the table below: Safety and tolerability were observed to be consistent with prior batoclimab studies. Phase 2b CIDP Study Results Highlights Initial batoclimab data in 73 patients pooled across all cohorts for the run-in Period 1 of the Phase 2b CIDP study demonstrated a 1.8 point improvement in aINCAT (compared to Period 1 baseline) at Week 12. An 84% responder rate (with response defined as an aINCAT improvement ≥ 1) was observed among all patients whose IgG was reduced by ≥ 70%. Other CIDP scales also demonstrated meaningful improvements for pooled batoclimab cohorts, with an improvement in I-RODS of 15.3, an improvement in MRC-SS of 5.6, and an improvement in grip strength of 15.1 all at Week 12. Safety and tolerability were observed to be consistent with prior batoclimab studies. Path Forward in MG and CIDP Immunovant plans to initiate potentially registrational studies in both MG and CIDP with lead asset IMVT-1402 and has received clearance for its Investigational New Drug (IND) applications for both indications as previously disclosed. Despite meaningful improvement for patients with MG and CIDP to date with the anti-FcRn class, there continues to be significant unmet need. IMVT-1402 is a potentially best-in-class anti-FcRn that may deliver deeper and more durable clinical responses for patients with MG, CIDP, and many other challenging autoimmune conditions. At present, Immunovant does not intend to seek regulatory approval for batoclimab in MG or CIDP and is focused on leveraging data and learnings from the batoclimab studies to inform and accelerate its programs with IMVT-1402. Immunovant will wait to make a final decision about regulatory submissions for batoclimab until the results of the ongoing Phase 3 studies of batoclimab in thyroid eye disease are available. Webcast Details The company will host an investor call and webcast with Immunovant CEO Dr. Pete Salzmann, M.D., MBA and Roivant CEO Matt Gline at 8:00 a.m. EDT today, March 19, 2025 to discuss these updates. Please click here to register for the event. The live webcast will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About Immunovant, Inc. Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. For additional information on the Company, please visit immunovant.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "can," “may,” “might,” “will,” “would,” “should,” “expect,” “believe,” “estimate,” “design,” “plan,” "intend," and other similar expressions are intended to identify forward-looking statements. Such forward looking statements include Immunovant’s expectations relating to the results of its batoclimab clinical trials; Immunovant's plan to develop IMVT-1402 in MG and CIDP; and the potential benefits of IMVT-1402 and its potential best-in-class profile. All forward-looking statements are based on estimates and assumptions by Immunovant’s management that, although Immunovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Immunovant expected. Such risks and uncertainties include, among others: initial results or other preliminary analyses or results of early clinical trials may not be predictive final trial results or of the results of later clinical trials; the timing and availability of data from clinical trials; the timing of discussions with regulatory agencies, as well as regulatory submissions and potential approvals; the continued development of Immunovant’s product candidates, including the timing of the commencement of additional clinical trials; Immunovant’s scientific approach, clinical trial design, indication selection, and general development progress; future clinical trials may not confirm any safety, potency, or other product characteristics described or assumed in this press release; any product candidate that Immunovant develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; Immunovant’s product candidates may not be beneficial to patients, or even if approved by regulatory authorities, successfully commercialized; the potential impact of global factors, geopolitical tensions, and adverse macroeconomic conditions on Immunovant’s business operations and supply chain, including its clinical development plans and timelines; Immunovant’s business is heavily dependent on the successful development, regulatory approval and commercialization of IMVT-1402 and batoclimab; Immunovant is at an early stage of development for IMVT-1402 and in various stages of clinical development for batoclimab; and Immunovant will require additional capital to fund its operations and advance batoclimab and IMVT-1402 through clinical development. These and other risks and uncertainties are more fully described in Immunovant’s periodic and other reports filed with the Securities and Exchange Commission (SEC), including in the section titled “Risk Factors” in Immunovant’s Form 10-Q filed with the SEC on February 6, 2025, and Immunovant’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Immunovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. About Roivant Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant-Forward Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Roivant Contacts: Investors: Keyur Parekh keyur.parekh@roivant.com Media: Stephanie Lee stephanie.lee@roivant.com