BRIM Biotechnology, Inc.

The prevalence of dry eye disease has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of dry eye disease and the growing research and development activities to develop novel therapies to treat dry eye disease to drive the market. The companies developing the potential therapies in the last stage of development include Aldeyra Therapeutics, RegeneRx Biopharmaceuticals, Mitotech, and several others. LAS VEGAS, May 23, 2023 /PRNewswire/ -- DelveInsight's ' Dry Eye Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of pipeline dry eye disease therapies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, and the future growth potential of the dry eye disease pipeline domain. Key Takeaways from the Dry Eye Disease Pipeline Report DelveInsight's dry eye disease pipeline report depicts a robust space with 50+ active players working to develop 60+ pipeline therapies for dry eye disease treatment. Key dry eye disease companies such as TearSolutions, Novaliq, HanAll Biopharma, Aldeyra Therapeutics, RegeneRx Biopharmaceuticals, Mitotech, Aerie Pharmaceuticals, Azura Ophthalmics, Stuart Therapeutics, Surface Ophthalmics, Glaukos Corporation, BRIM Biotechnology Inc., Dompé Farmaceutici S.p.A, Okyo Pharma Ltd, AxeroVision, Inc., Palatin Technologies, Seikagaku Corporation, Invirsa, Inc., Allysta Pharmaceutical, Taejoon Pharmaceutical Co., Ltd., Ocular Therapeutix, Inc., Dreamhawk Vision Biotech, Inc., Yuyu Pharma, Inc., Novartis Pharmaceuticals, VivaVision Biotech, Inc, Huons Co., Ltd., and others are evaluating new dry eye disease drugs to improve the treatment landscape. Promising dry eye disease pipeline therapies in various stages of development include Reproxalap, Timbetasin, Visomitin, HL036, CyclASol, Lacripep, AR15512, AZR MD 001, ST-100, SURF-100, SURF-200, GLK-301, BRM421, Oxervate, OK-101, AXR 159, AXR 270, PL9643, SI-614, INV-102, ALY688, TJO-083, OTX-CSI, OTX-DED, SHJ002, YP-P10, ECF843, VVN001, HU007 and others. In March 2023, Selagine, Inc., a spin-out company from the University of Illinois at Chicago (UIC), announced that it has entered into a research, development, and sublicense agreement with Grifols (Nasdaq: GRFS), a global leader in plasma-derived medicines, for the development and commercialization of immunoglobulin eye drops for dry eye disease.Under the agreement, Selagine will receive an upfront payment and annual collaboration fee. In addition, Grifols has committed to fund the development of immunoglobulin eye drops through FDA approval, which will be managed collaboratively by Grifols and Selagine, including the clinical, manufacturing and regulatory activities required for FDA approval for dry eye disease indication. In February 2023, Aldeyra Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for topical ocular reproxalap, a first-in-class investigational new drug candidate, for the treatment of the signs and symptoms of dry eye disease. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of November 23, 2023. The FDA noted that no potential filing review issues have been identified, and that an advisory committee meeting is not currently planned. In February 2023, Novaliq, announced its plans for filing a Marketing Authorisation Application (MAA) for CyclASol® (ciclosporin ophthalmic solution), a first-of-its-kind anti-inflammatory product for the treatment of dry eye disease (DED) in the European Union. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) determined that CyclASol® is eligible to be reviewed in a centralized procedure to receive a Union Marketing Authorisation for the European Economic Area (EEA). In January 2023, Bausch + Lomb Corporation and Novaliq GmbH, announced that Ophthalmology, the peer-reviewed journal of the American Academy of Ophthalmology, has published results from the pivotal Phase 3 trial GOBI, which is one of two pivotal Phase 3 trials for NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).In the study, NOV03 was well tolerated with few subjects experiencing ocular adverse events (AEs) (9.6% NOV03 group, 7.5% control group) or treatment-related ocular AEs (6.3% NOV03 group, 3.1% control group). In August 2022, Alcon and Aerie Pharmaceuticals, Inc. announced the companies have entered into a definitive merger agreement through which Alcon acquired Aerie. The transaction affirmed Alcon's commitment to the ophthalmic pharmaceutical space and is expected to add broader pharmaceutical R&D capabilities to Alcon's existing commercial expertise, maximizing the value of its diversified portfolio. Through the transaction, Alcon added the commercial products Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% and Rhopressa® (netarsudil ophthalmic solution) 0.02%, as well as AR-15512, a Phase 3 product candidate for dry eye disease, and a pipeline of several clinical and preclinical ophthalmic pharmaceutical product candidates. In May 2022, Yuyu Pharmaceutical presented a poster study for YP-P10, its new dry eye syndrome treatment, during the 2022 ARVO (Association for Research in Vision and Ophthalmology) conference. YP-P10 is a new biopharmaceutical using synthetic peptides, aiming to relieve signs and symptoms of dry eye syndrome caused by inflammation by administering the treatment twice a day. According to preclinical trial results unveiled at the conference, Yuyu confirmed that the candidate had an excellent anti-inflammatory mechanism and corneal epithelial cell healing effect compared to existing drugs. Request a sample and discover the recent advances in dry eye disease drug treatment @ Dry Eye Disease Pipeline Report The dry eye disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage dry eye disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the dry eye disease clinical trial landscape. Dry Eye Disease Overview Dry eye disease is characterized as a multifactorial disease of the tears and ocular surface that causes symptoms such as pain, visual disruption, and tear film instability, as well as potential ocular surface damage. It is accompanied by increased tear osmolarity and transient ocular surface irritation. When tear production and drainage are out of balance, dry eyes can result. People with dry eyes either do not produce enough tears or have poor-quality tears. Dry eyes can occur for various reasons, including age, gender, drugs, and medical disorders. Dry eye disease symptoms include redness, stinging, itching, or burning sensations, light sensitivity, watery eyes, stringy mucus near the eye, and blurred vision. A thorough eye examination can detect dry eyes. Dry eye disease treatments seek to restore or maintain the usual number of tears in the eye in order to reduce dryness and associated discomfort and to maintain eye health. The basic approaches used to manage and treat dry eyes include adding tears with over-the-counter artificial tear solutions, conserving tears, boosting tear production, and treating the inflammation of the eyelids or eye surface that contributes to dry eyes. Find out more about drugs for dry eye disease @ New Dry Eye Disease Drugs A snapshot of the Dry Eye Disease Pipeline Drugs mentioned in the report: Learn more about the emerging dry eye disease pipeline therapies @ Dry Eye Disease Clinical Trials Dry Eye Disease Therapeutics Assessment The dry eye disease pipeline report proffers an integral view of dry eye disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Dry Eye Disease Pipeline Report Coverage: Global Dry Eye Disease Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Dry Eye Disease Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Dry Eye Disease Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Dry Eye Disease Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Dry Eye Disease Therapeutics Assessment By Mechanism of Action: Malondialdehyde inhibitors, Actin modulators, Amyloid inhibitors, Angiogenesis inducing agents, Apoptosis inhibitors, Cell movement activators, Collagen stimulants, Heat-shock protein modulators, MicroRNA modulators, Nerve growth factor stimulants, NF-kappa B inhibitors, Stem cell stimulants, Antioxidants, Electron transport chain complex protein modulators, Lipid modulators, Tumour necrosis factor alpha inhibitors, Eye protein modulators, TRPM8 protein stimulants, Glucocorticoid receptor agonists, Inosine monophosphate dehydrogenase inhibitors, Muscarinic receptor agonists Key Dry Eye Disease Companies: TearSolutions, Novaliq, HanAll Biopharma, Aldeyra Therapeutics, RegeneRx Biopharmaceuticals, Mitotech, Aerie Pharmaceuticals, Azura Ophthalmics, Stuart Therapeutics, Surface Ophthalmics, Glaukos Corporation, BRIM Biotechnology Inc., Dompé Farmaceutici S.p.A, Okyo Pharma Ltd, AxeroVision, Inc., Palatin Technologies, Seikagaku Corporation, Invirsa, Inc., Allysta Pharmaceutical, Taejoon Pharmaceutical Co., Ltd., Ocular Therapeutix, Inc., Dreamhawk Vision Biotech, Inc., Yuyu Pharma, Inc., Novartis Pharmaceuticals, VivaVision Biotech, Inc, Huons Co., Ltd., and others. Key Dry Eye Disease Pipeline Therapies: Reproxalap, Timbetasin, Visomitin, HL036, CyclASol, Lacripep, AR15512, AZR MD 001, ST-100, SURF-100, SURF-200, GLK-301, BRM421, Oxervate, OK-101, AXR 159, AXR 270, PL9643, SI-614, INV-102, ALY688, TJO-083, OTX-CSI, OTX-DED, SHJ002, YP-P10, ECF843, VVN001, HU007, and others. Dive deep into rich insights for new drugs for dry eye disease treatment; visit @ Dry Eye Disease Medications Table of Contents For further information on the dry eye disease pipeline therapeutics, reach out @ Dry Eye Disease Drug Treatment Related Reports Dry Eye Disease Market Dry Eye Disease Market Insights, Epidemiology, and Market Forecast – 2032 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 dry eye disease companies, including Oyster Point Pharma, Aerie Pharmaceuticals, Azura Ophthalmics, Stuart Therapeutics, Surface Ophthalmics, Glaukos Corporation, among others. Dry Eye Disease Epidemiology Forecast Dry Eye Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and dry eye disease epidemiology trends. Mild Dry Eye Market Mild Dry Eye Market Insights, Epidemiology, and Market Forecast – 2032 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 mild dry eye companies, including Allergan Plc., Novartis AG., Otsuka Pharmaceutical Co. Ltd., Santen Pharmaceutical Co. Ltd., among others. Moderate Dry Eye Market Moderate Dry Eye Market Insights, Epidemiology, and Market Forecast – 2032 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 moderate dry eye companies, including Santen Pharmaceutical Co. Ltd., OASIS Medical, Alcon Inc., Bausch Health Companies Inc., AbbVie 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] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

None  Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please send the good word—or the bad—from your shop to Max Bayer or Gabrielle Masson, and we will feature it here at the end of each week.  Roivant Sciences founder ditches company board for White House bid Roivant Sciences D.C.-vant? Washington-vant? Commander-in-vant? The names don’t particularly roll off the tongue, but they’re reflective of the new grandiose ambition of Roivant founder Vivek Ramaswamy. The entrepreneur-turned-anti-woke-pariah announced a formal run this week for the White House, becoming the third Republican candidate to enter the field. As a part of the decision, Ramaswamy departed from Roivant’s board.  His pursuit of arguably the most significant political office in the world comes less than 10 years after Ramaswamy launched Roivant. The company has since spun out more than 20 “vant” subsidiaries, which essentially act as small spinouts focused on the development of a specific drug or disease area. Existing vants include dermatology-focused Dermavant and Immunovant, which is tailored to … you probably guessed it.  But you won’t hear much about Roivant in Ramaswamy’s launch video, which is focused squarely on what he bemoans is a nationwide “identity crisis” and the “woke left.” It’s much of the same views that Ramaswamy has championed for years as he’s made himself one of the key figures fighting against the intersection of social politics and corporate life. He won’t be the only former entrepreneur in the race, however, taking on the current polling favorite and former President Donald Trump. Fierce Biotech Top FDA oncology deputy departs for new biotech Food and Drug Administration  Julia Beaver, M.D., has departed the FDA to take on a new role as senior vice president of clinical development at Treeline Biosciences. Beaver was previously chief medical officer of the FDA’s Oncology Center for Excellence and acting deputy director of the Office of Oncologic Diseases. Her departure was confirmed by the agency.  Beaver’s move marks her first foray into industry after working for nine and a half years at the FDA following nine years at Johns Hopkins. The cancer professor and regulator now heads up clinical development at one of the buzziest biotechs in the business. Treeline has raised almost half a billion dollars including a $261 million series A.  Ironically, the CEO of Treeline is a former regulator himself. Josh Bilenker, M.D., was a medical officer at the agency before launching Loxo Oncology in 2013, which was ultimately sold to Eli Lilly for $8 billion in 2019. According to Bilenker’s LinkedIn, he started working on Treeline in April 2021. LinkedIn   Medidata names new top executives  Medidata  Medidata announced that it had tapped Pascal Daloz to be its new chief executive, finding a permanent replacement after an 18-month search. Daloz, who was influential in Dassault Systèmes acquisition of Medidata in 2019, replaces co-CEOs Rama Kondru and Sastry Chilukuri. The company also announced it had tapped former chief commercial officer Michael Pray to be chief operating officer.   The two major hires come a year and a half after Kondru and Chilukuri were named interim co-CEOs of the life science software provider. Just weeks later, Medidata’s co-founder, Glen de Vries, died in a plane crash in New Jersey. De Vries launched the company in 1999 and sold it to Dassault in 2019. And his love of aviation was emblematic in the fact that he was one of a handful of people to join Amazon founder Jeff Bezos on a Blue Origins flight earlier in 2021.  In its hiring announcement, Medidata says Pray will be responsible for day-to-day operations at the company and will report directly to Daloz. Fierce Biotech > Moderna’s Juan Andres will be retiring in May after working at the Big Pharma for more than six years. Andres is currently president of strategic partnerships and enterprise expansion for the company, and has also served as chief technical operations and quality officer. Prior to Moderna, Andres held leadership roles at Eli Lilly and Novartis. Release  > Having already drastically reduced head count, ObsEva has now turned its sights on the company’s U.S.-based leadership. The women’s-health focused biotech waved goodbye to CEO Brian O’Callaghan, Chief Commercial Officer Clive Bertram, Chief Clinical Officer Brandi Howard and Chief Transformation Officer Luigi Marro. Clancy and O’Callaghan are among five board members who will be stepping down. The biotech has already began a search for a CEO who will be based at the company’s home of Switzerland. Fierce Biotech > CymaBay Therapeutics Chief Medical Officer Dennis Kim, M.D., resigned Feb. 20, effective immediately. Release > Precision BioSciences is shaking up its leadership team, promoting VP of CMC Neil Leatherbury to SVP, head of CMC. Meanwhile, Co-Founder and Chief Scientific Officer Derek Jantz, Ph.D., has announced his intentions to eventually step away from his current day-to-day responsibilities and will instead take on the role of chief science advisor. Additionally, Co-Founder and Chief Research Officer Jeff Smith, Ph.D., will tack on leadership of the Precision's joint steering committees with Eli Lilly and Novartis and serve as head scientific lead for potential new business development partners. Release > Arthur Levin, Ph.D., is transitioning out of his role as Avidity’s chief scientific officer to the board of directors and the role of distinguished scientist and strategic leader. Levin is a founding member of Avidity, and his spot as CSO will be taken up by Chief Technical Officer Michael Flanagan, Ph.D., who will remain in his current role as well. Release   > NextPoint Therapeutics has appointed Leena Gandhi, M.D., Ph.D., to serve as chief medical officer and oversee development of its precision immuno-oncology programs. Gandhi previously worked at the Dana-Farber Cancer Institute, where she was director of the Center for Cancer Therapeutic Innovation, and has also previously served as Eli Lilly’s VP of immuno-oncology development. Release > After ending all cardiology work, Quantum Genomics is reorganizing its board of directors, restructuring staff and conducting another strategic review. Frédéric Duchesne resigned from his role as independent administrator, while founder and President Lionel Ségard has been ousted and will be replaced with CEO Jean-Philippe Milon. Fierce Biotech > Chester Wong is jumping from Big Pharma to biotech, exiting his role as director of business development for Amgen to become Cartography Biosciences’ VP and head of business development. Wong will help the biotech, which emerged last summer, form key industry relationships that advance its pipeline of next-gen cancer immunotherapies. Release    > After a business review, Graphite Bio is writing off a sickle cell therapy and cutting half its staff—including two executives. Chief Business Officer Philip Gutry and Chief Scientific Officer Jane Grogan, Ph.D., are slated to leave the company at the end of the second quarter. Fierce Biotech > Transcend Therapeutics has emerged with a $40 million series A and several C-suite leaders. The biotech working to develop meds for neuropsychiatric diseases is led by co-founder and CEO Blake Mandell, who has spent most of his career working in venture capital. Fellow co-founder Kevin Ryan, who is also the founder and CEO AlleyCorp, will serve as chair for Transcend, while third co-founder Ben Kelmendi, M.D., will hold the spot as chief scientific adviser. Meanwhile, Martin Stogniew, Ph.D., who has led development at six biotech startups, will take on the role of chief development officer. In the spot of SVP of clinical development is Amanda Jones, who most recently led clinical development at Axsome Therapeutics. Release   > Impel Pharmaceuticals is reducing its head count by 16% to save cash, with Chief Medical Officer Stephen Shrewsbury, M.D., also heading out the door at the end of March. Fierce Biotech   > Alongside the launch of a new wet-dry lab, Relation Therapeutics has tapped Edith Hessel, Ph.D., to fill its chief scientific officer spot. Hessel is a former GSK R&D exec and helped build out the Big Pharma’s Refractory Respiratory Inflammation Discovery Performance Unit. Release  > Starting March 1, Taiwan-based BRIM Biotechnology will have a new CEO at the helm. Dr. Wen-Chyi Shyu is taking the reins from Dr. Haishan Jang, Brim’s CEO and chair. Shyu has clocked in experience for many Big Pharmas, including Bristol Myers Squibb and Takeda, and will help the biotech expand internationally. Meanwhile, globally known entrepreneur Andrew Lin will take over as company chair. Release > Kate Broderick will become Maravai Life Sciences’ chief innovation officer of the newly created office of science and innovation. Broderick joined Maravai’s TriLink Biotechnologies in July 2022 as SVP of R&D and, before that, spent 15 years at Inovio Pharmaceuticals. Release  > AI-driven Genomenon has tapped John Battles to serve as its VP of engineering. Battles has more than 25 years of experience in the field, with past roles at Genomind and Q2 Solutions, among others. Release

Cigall Kadoch has won an appointment as an investigator at the Howard Hughes Medical Institute — and subsequently will be resigning from Flagship’s Foghorn Therapeutics board. Kadoch, who co-founded Foghorn in 2016, will continue working with the company, but as a scientific advisor. Foghorn CEO Adrian Gottschalk said in a prepared statement: Foghorn, however, is facing trouble as its partial clinical hold on a blood cancer treatment was converted into a full clinical hold in August. The initial hold came in May after a patient died in Foghorn’s early stage trial for FHD-286. The drug is meant to target two key proteins of the “BAF complex,” and is part of Foghorn’s bigger picture to treat cancer by drugging chromatin, or packaged DNA. — Lei Lei Wu BRIM Biotechnology, which recently listed on a Taiwanese stock exchange, has announced a seasoned equity offering to fund a Phase III trial for its dry eye treatment. The biotech will be offering NTD 500-600 million, or approximately $17-20 million USD, in common stock. One week after it went public in June, the biotech reported that its eye drops had shown “promising results” in a Phase II study — though it whiffed on the primary endpoint. That study was conducted on 220 patients in the US but did not show statistically significant improvement in corneal repair or patient-reported outcomes. The biotech highlighted that the study had statistically significant results in a few secondary measures. Regardless, the biotech will be moving forward with its Phase III study on its lead candidate BRM421, and it has a meeting lined up with the FDA later this year to discuss that prospect. — Lei Lei Wu Palo Alto-based Guardant Health has expanded its tie-up with German biotech Merck KGaA. The California cancer screening and testing company will offer up its real-world evidence know-how to “accelerate development” work on its partner’s precision oncology drugs, the companies said Wednesday. Applying to “core cancer indications with significant unmet need,” the collaboration expands upon previous work the pair has done together. The life sciences tech company developed its biomarker detection tool GuardantOMNI in collaboration with Merck KGaA and a host of other biopharma partners, including the other Merck, Pfizer, AstraZeneca and Bristol Myers Squibb. Merck KGaA’s researchers will team up with Guardant’s data scientists to tap into genomics and clinical information, the companies said. — Kyle LaHucik