HCPLive Podcasts

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 Healthcare Headlines for March 23-30, 2025:Zetomipzomib Shows Promise for Autoimmune Hepatitis in Phase 2a PORTOLA TrialZetomipzomib demonstrated steroid-sparing biochemical remissions in refractory autoimmune hepatitis patients, aligning with AASLD treatment guidelines in the Phase 2a PORTOLA trial.Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 TrialSolriamfetol met its primary endpoint in the Phase 3 FOCUS trial, significantly improving ADHD symptoms, with a higher proportion of patients achieving clinical response compared to placebo.Sozinibercept for Wet AMD Misses Primary Endpoint in Phase 3 COAST TrialSozinibercept combined with aflibercept failed to meet the primary endpoint for visual acuity improvement in wet AMD, showing no added benefit over aflibercept monotherapy.FDA Approves Gepotidacin (Blujepa) for Uncomplicated UTIThe FDA approved gepotidacin for uncomplicated urinary tract infections based on Phase 3 trials demonstrating non-inferiority to nitrofurantoin in female adults and adolescents.FDA Issues CRL for Etripamil Nasal Spray (Cardamyst) in PSVTThe FDA issued a Complete Response Letter for etripamil nasal spray, citing manufacturing and control issues while confirming no concerns regarding its clinical safety or efficacy.

Welcome back to New Insight with Veeral Sheth, MD!Veeral Sheth, MD, is joined by Rich Small, the CEO of Neurotech, to discuss the historic approval of revakinagene taroretcel (ENCELTO) a groundbreaking encapsulated cell therapy for macular telangiectasia type 2 (MacTel). This approval marked the first and only FDA–approved treatment for MacTel, a neurodegenerative disease of the retina that can cause progressive and irreversible vision loss.Speaking with Sheth, Small recounted the long journey of Neurotech, which began in 2007, emphasizing the perseverance required to bring ENCELTO to market. He detailed his transition from Chief Financial Officer to CEO in 2016 and highlighted his team’s commitment, many of whom have been with the company for over a decade.The conversation explored the scientific foundation of ENCELTO, which uses genetically modified cells to release neurotrophic factors that protect photoreceptors in the retina. Unlike previous treatments that relied on best corrected visual acuity (BCVA) as a clinical endpoint, ENCELTO’s approval was enabled by advancements in imaging technology that allowed for direct measurement of photoreceptor health. Sheth and Small discussed the ideal patient profile for ENCELTO, noting that early intervention is key to preserving vision in MacTel patients.With ENCELTO’s approval secured, Small indicated the next step is widespread adoption, introducing ENCELTO.com as a patient service hub designed to streamline diagnosis, treatment, and access to care. #Ophthalmology #Podcast #RareDisease

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!New ACP Guidelines Recommend Adding Triptan to NSAID or Acetaminophen for Migraines The American College of Physicians now recommends adding a triptan to NSAIDs or acetaminophen for moderate to severe acute migraines and urges clinicians to initiate combination therapy early.Automated Insulin Delivery Effectively Lowers HbA1c in Type 2 Diabetes Tandem Diabetes Care’s Control-IQ+ automated insulin delivery system led to greater HbA1c reduction than continuous glucose monitoring alone in adults with insulin-requiring type 2 diabetes.FDA Approves Guselkumab (Tremfya) For Crohn's Disease The FDA approved guselkumab for moderately to severely active Crohn’s disease based on phase 3 trial data demonstrating superior efficacy over ustekinumab on endoscopic endpoints.FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy The FDA approved iptacopan as the first therapy for C3 glomerulopathy, with phase 3 data showing significant proteinuria reduction and sustained efficacy at 12 months.FDA Approves Vutrisiran (AMVUTTRA) for ATTR-CM The FDA expanded vutrisiran’s approval for cardiomyopathy in transthyretin-mediated amyloidosis, making it the first RNAi therapeutic to reduce cardiovascular mortality and hospitalizations in ATTR-CM.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 healthcare headlines for March 9-16, 2025:1. CagriSema Yields Nearly 16% Weight Loss in Phase 3 REDEFINE 2 TrialIn the Phase 3 REDEFINE 2 trial, CagriSema showed weight reduction in adults with obesity or overweight and type 2 diabetes, outperforming placebo.2. Lorundrostat Significantly Lowers Blood Pressure in Key Hypertension TrialsThe Phase 3 Launch-HTN and Phase 2 Advance-HTN trials showed lorundrostat effectively reduced blood pressure in uncontrolled or resistant hypertension with a favorable safety profile.3. PharmaTher Receives New Early June FDA Goal Date for KetaminePharmaTher announced the FDA set a new Priority Review goal date of June 4, 2025, for ketamine to treat anesthesia, pain, mental health, and neurological conditions.4. FDA Awards Fast Track Designation to ATSN-201 Gene Therapy for XLRSThe FDA granted Fast Track designation to ATSN-201 for X-linked retinoschisis, allowing Atsena Therapeutics to seek Priority Review for their gene therapy.5. FDA Approves First Interchangeable Biosimilar for OmalizumabThe FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to Xolair for asthma, CRSwNP, IgE-mediated food allergy, and CSU.

Video version available on HCPLive!In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, speaks with Riad Sherif, MD, chief executive officer of Oculis, about the company's groundbreaking advancements in ophthalmic therapeutics.The discussion delves into Oculis' clinical pipeline, particularly OCS-05, a neuroprotective agent demonstrating promising results in acute optic neuritis. The Phase 2 ACUITY trial showed that OCS-05 preserved retinal ganglion cells (RGCs), reduced axonal loss, and improved low-contrast visual acuity. Importantly, patients receiving OCS-05 experienced significantly fewer multiple sclerosis relapses, suggesting broader neuroprotective potential. Administered intravenously alongside corticosteroids, the therapy could represent a paradigm shift in preserving vision in acute optic neuritis and beyond.Sheth and Sherif also explore Oculis' lead candidate, OCS-01, a topical treatment for diabetic macular edema (DME) that utilizes Optireach™ technology to penetrate the retina. With two ongoing Phase 3 trials (DIAMOND 1 and 2), OCS-01 has the potential to offer a non-invasive alternative or adjunct to intravitreal injections, expanding treatment options for patients with DME. Additionally, Oculis' OCS-02, a TNF inhibitor for dry eye disease, integrates a biomarker-driven precision medicine approach, ensuring targeted therapy for responders and potentially revolutionizing dry eye treatment.Looking ahead, Oculis is focused on executing its clinical programs, particularly finalizing patient randomization in the DIAMOND trials, advancing precision medicine for inflammation, and expanding indications for OCS-05 in neuroprotection. Sherif envisions OCS-05 as a potential game-changer, addressing significant unmet needs in ophthalmology and neurology by preserving vision and improving quality of life for patients facing vision-threatening diseases.Key Episode Timestamps00:00:06 Introduction to New Insight00:01:13 Riad Sherif's Journey from Physician to CEO00:05:23 Challenges of Balancing Medical and Business Roles00:09:44 Oculis' Portfolio and Recent Developments00:14:40 OCS 05 and Its Clinical Applications00:20:22 Oculis' Team and Leadership Philosophy00:24:35 Future Goals and Vision for Oculis

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!Interested in a more traditional, text rundown? Check out the HCPFive!Top 5 healthcare headlines for February 16 - 23, 2025:1. Sotagliflozin Cuts MACE Risk By 23% in Patients with Type 2 Diabetes, CKDDual SGLT1/2 inhibition with sotagliflozin significantly reduced both heart attacks and stroke in a prespecified secondary analysis of the SCORED trial.2. Nebokitug (CM-101) Gets FDA Runway for PSC ApprovalChemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC.3. FDA Clears IND Application for Zabalafin Hydrogel Treatment of Atopic DermatitisAlpyn’s Investigational New Drug application’s clearance by the FDA for the new Zabalafin Hydrogel for atopic dermatitis follows positive phase 2a clinical findings.4. Expert Panel Develops Consensus Definition, Clinical Tool for Anaphylaxis CareA 46-member expert panel created a consensus anaphylaxis definition, overview, and clinical tool to aid clinicians in recognition and management across settings.5. FDA Announces End to Shortage of Semaglutide Products (Ozempic, Wegovy)The US supply of semaglutide and semaglutide 2.4 mg now meets or exceeds current and projected demand, ending the long-running shortages of these blockbuster drugs.

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included the US Food and Drug Administration's (FDA) acceptance of a Biologics License Application (BLA) for a cholesterol-lowering drug, long-term data on a dermatologic treatment for hidradenitis suppurativa, an expanded dosing label for a blinding eye disease treatment, and more!With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of February 09, 2025—let’s jump in!Interested in oncology news? Check out The OncFive, from our sister publication OncLive.Top News for Healthcare Providers from the Week of 02/091. FDA Accepts Lerodalcibep BLA for LDL-C Reduction in High-Risk PatientsThe FDA accepted the BLA for lerodalcibep, targeting reductions in low-density lipoprotein cholesterol (LDL-C) levels in patients with or at high risk for atherosclerotic cardiovascular disease (ASCVD) and primary hyperlipidemia. The agency set a Prescription Drug User Fee Act (PDUFA) action date of December 12, 2025, and announced no plans to hold an advisory committee meeting.2. Travere Therapeutics Plans FSGS Submission for SparsentanTravere Therapeutics announced its intent to submit a supplemental New Drug Application (sNDA) for sparsentan (Filspari) with the FDA for the treatment of focal segmental glomerulosclerosis (FSGS) at the end of Q1. The announcement arrived soon after the completion of a Type C meeting with the FDA, with the sNDA based on existing data from the Phase 3 DUPLEX and Phase 2 DUET studies.3. Bimekizumab Long-Term Hidradenitis Suppurativa Data Support Efficacy, Safety ProfileBimekizumab (Bimzelx) was associated with sustained disease control for up to 2 years in patients with hidradenitis suppurativa (HS), according to presentation of long-term data from the BE HEARD trials. Presented at the 14th Conference of the European Hidradenitis Suppurativa Foundation (EHSF), bimekizumab reduced the symptoms of HS, achieved a low rate of flares, and improved health-related quality of life.4. Rosnilimab Demonstrates Historic Responses for Rheumatoid ArthritisRosnilimab achieved historic American College of Rheumatology (ACR) and clinical disease activity index (CDAI) low disease activity (LDA) responses in patients with rheumatoid arthritis (RA), according to new Phase 2b findings. A depleter and agonist of PD-1+ T cells, rosnilimab was evaluated in the global 424-patient RENOIR trial for efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with moderate-to-severe RA on background conventional disease-modifying antirheumatic drugs (cDMARDs).5. FDA Expands Dosing Label for Avacincaptad Pegol for Geographic AtrophyThe FDA approved an expanded label for avacincaptad pegol intravitreal solution (IZERVAY) for geographic atrophy (GA), extending the approved dosing beyond 12 months. Announced by Astellas Pharma, the decision comes after the company resubmitted its supplemental New Drug Application (nDA) in December 2024, based on feedback received from the FDA. The company received a Complete Response Letter (CRL) the month prior.See you next week!Editor's note: this was created with the assistance of AI tools.

Time Stamps:00:00 Introduction to GLP-1 Agonists and Ethical Considerations03:38 Current Landscape and Insurance Coverage06:04 Fair Priority Model and Ethical Principles13:37 Application of Principles and Tiered Allocation34:30 Challenges and Objections to the Framework38:41 Future Considerations and Broader ApplicationsVideo version available on YouTube.In this episode of Medical Ethics, Steve Levine, Dom Sisti, and guest Johan Dellgren explore the challenges surrounding the equitable allocation of GLP-1 receptor agonists (GLP-1 RAs). As these medications gain recognition for their effectiveness in treating obesity and type 2 diabetes, the discussion explores the systemic barriers preventing equal access, including high costs, insurance coverage limitations, and broader health disparities. The panel emphasizes the importance of prioritizing those at highest medical risk while also addressing the root causes of healthcare inequities. Watch to learn more about the ethical considerations and potential solutions in ensuring these medications reach those who need them most.

Video Version Available on YouTube!In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, explored the approval and impending launch of Qlosi (pilocarpine HCL ophthalmic solution) 0.4%, a groundbreaking pharmacologic option for managing presbyopia, with Elad Kedar, MBA, chief executive officer of Orasis Pharmaceuticals.A condition that affects nearly all adults as they age, presbyopia is characterized by the gradual loss of near vision due to reduced lens elasticity. Sheth and Kedar highlighted the significance of finding non-invasive treatment options for this pervasive issue, given the limitations of traditional solutions like reading glasses or surgical interventions.In October 2023, the US Food and Drug Administration (FDA) approved Qlosi, a preservative-free, low-dose eye drop for presbyopia, based on strong efficacy, safety, and tolerability data reported in the pivotal Phase 3 NEAR-1 and NEAR-2 clinical trials. On Day 8, patients treated with Qlosi achieved statistically significant ≥3-line gain in distance-corrected near visual acuity (DCNVA) and no loss of ≥1-line in distance visual acuity.Sheth and Kedar delved into Qlosi’s innovative mechanism of action, emphasizing how it leverages a unique pharmacologic approach to improve near vision. By modulating pupil dynamics, Qlosi enhances the depth of focus, effectively allowing patients to perform near-vision tasks without additional aids. Together, Sheth and Kedar walked through the drug’s clinical development journey, highlighting his journey through the founding of Orasis and the company’s name in Greek, meaning “good vision or sight.”The discussion included insights into the populations most likely to benefit from Qlosi and the practical considerations for prescribing. Sheth offered a nuanced take on how this therapy could fit into the broader landscape of presbyopia management, addressing questions about patient education, adherence, and expectations.Sheth also shared his perspective on the potential impact of Qlosi on clinical practice, noting that its ease of use and non-invasive nature could appeal to both patients and providers. He reflected on how treatments like Qlosi are part of a broader trend toward personalized medicine, focusing on solutions that improve the quality of life for aging populations.This episode concluded with a thoughtful look at future research directions and the impending launch of Qlosi. Expected soon, Kedar expressed an interest in sharing more details on the product and its position in the presbyopia treatment landscape once the drug comes to market.Every episode of New Insight is available on HCPLive.com. Watch full episodes on our YouTube channel and listen wherever you get your podcasts. Direct all podcast-related inquiries to show producer Connor Iapoce ([email protected]) and keep an eye out for more from New Insight!Key Episode Timestamps00:05 Introduction to Elad Kedar and Orasis04:34 Orasis' Journey and Initial Development06:45 Elad Kedar's Background and Company Growth08:36 Transition from Product Development to Team Building11:42 Phase Three Study Results and Efficacy13:39 Safety, Comfort, and Tolerability15:00 Genesis of the Company Name Orasis18:26 Challenges and Strategic Planning21:57 Market Position and Future Outlook27:27 Conclusion and Future Plans

In the first episode of Medical Ethics Unpacked, hosts Steve Levine, MD, and Dominic Sisti, PhD, examine the profound ethical and clinical challenges surrounding medically assisted suicide, or medical assistance in dying (MAID), for individuals with severe psychiatric conditions. Dr. Sisti, an associate professor at the University of Pennsylvania, interrogates pivotal questions central to this debate, including whether psychiatric disorders can be deemed terminal and whether individuals with such conditions possess the requisite capacity to make autonomous decisions regarding MAID. Drawing on data from jurisdictions such as Belgium and the Netherlands, he highlights critical concerns, including gender disparities, inconsistent capacity evaluations, and the societal risks of expanding access to psychiatric euthanasia without addressing structural deficiencies, such as inadequate mental health care systems or pervasive social inequities.Dr. Levine, a psychiatrist, explores the complex and dynamic nature of capacity assessments, emphasizing the episodic and often treatable trajectory of psychiatric conditions such as major depressive disorder and anorexia nervosa. He reflects on the potential for recovery facilitated by novel treatments, such as ketamine or psychedelics, juxtaposed with the limitations and gaps in current psychiatric care. Together, the hosts deliberate on the ethical implications of mandating exhaustive treatment attempts, including experimental options, before permitting MAID, balanced against the imperative to respect patient autonomy.Through a rigorous and nuanced discussion, Drs. Levine and Sisti advocate for the establishment of robust ethical frameworks, equitable practices, and comprehensive capacity evaluations. Their discourse challenges societal and professional norms, encouraging reflection on autonomy, human suffering, and the intrinsic value of life in the context of this ethically fraught issue.Relevant studies and documentation mentioned in this episode: Doernberg, Samuel N., John R. Peteet, and Scott YH Kim. "Capacity evaluations of psychiatric patients requesting assisted death in the Netherlands." Psychosomatics 57, no. 6 (2016): 556-565. Kim, Scott YH, Raymond G. De Vries, and John R. Peteet. "Euthanasia and assisted suicide of patients with psychiatric disorders in the Netherlands 2011 to 2014." JAMA psychiatry73, no. 4 (2016): 362-368. Kious, Brent M., and Margaret Battin. "Physician aid-in-dying and suicide prevention in psychiatry: A moral crisis?." The American Journal of Bioethics 19, no. 10 (2019): 29-39. Nicolini, Marie E., Scott YH Kim, Madison E. Churchill, and Chris Gastmans. "Should euthanasia and assisted suicide for psychiatric disorders be permitted? A systematic review of reasons." Psychological medicine 50, no. 8 (2020): 1241-1256. Nicolini, Marie E., Chris Gastmans, and Scott YH Kim. "Psychiatric euthanasia, suicide and the role of gender." The British Journal of Psychiatry 220, no. 1 (2022): 10-13. Sisti, Dominic, J. John Mann, and Maria A. Oquendo. "Suicidal behaviour is pathological: implications for psychiatric euthanasia." Journal of Medical Ethics (2024). Relevant disclosures for Sisti include Lykos Therapeutics and Tactogen. Relevant disclosures for include Levine include Compass Pathways.Chapters 00:00 - Introduction00:45 - Key Issues in the Debate on Euthanasia and Mental Illness07:25 - Clinical Perspective on Capacity and Competence12:45 - Challenges in Evaluating Capacity in Mental Illness19:32 - Treatment Options and the Role of Social Structures26:35 - The Parity Between Mental and Physical Illness31:41 - Requiring Treatment Before Considering Euthanasia34:44 - The Complexity of Egosyntonic Psychiatric Conditions37:52 - The Potential for "Terminal Addiction"43:05 - The Societal Impact and Implications of Psychiatric Euthanasia

Lauren Miller, MPAS, PA-C; Jayme M. Heim, MSN FNP-BC, and Lakshi Aldredge, MSN, ANP-BC, discuss recent advancements in plaque psoriasis treatment, focusing on novel oral systemic therapies like the TYK-2 inhibitor deucravacitinib and its clinical trial data, to inform therapeutic decisions for this systemic disease.

Corneal blindness has a significant public health impact, particularly in low- and middle-income countries where access to eye care is limited. It can contribute to a high burden of disability, affecting individuals' quality of life and economic productivity, while straining healthcare systems with the need for preventive measures, surgical treatments, and rehabilitation services. In the latest episode of New Insight, host Veeral Sheth, MD is joined by John Sheets, PhD, the president, chief executive officer, and co-founder of Pantheon Vision, a pioneering early research-stage organization working to develop bioengineered solutions to eliminate corneal blindness and restore sight to millions. As part of its mission, Pantheon is dedicated to reducing reliance on donated corneal tissues to address corneal blindness. Although corneal transplant surgery has long been the gold standard, there remains significant room for improvement in graft acceptance, vision restoration, and long-term outcomes to better combat corneal blindness. Highlights 0:06 Introduction 2:20 Sheet's Background 6:30 Experience with FDA 10:58 Mission of Pantheon Vision 17:10 Corneal Transplant Alternatives 22:54 Overcoming Challenges 28:49 Conclusion #ophthalmology #cornea #podcast

Proton pump inhibitors have long been the mainstay of treatment for gastroesophageal reflux disease (GERD), dating back to omeprazole (Prilosec)’s initial approval in 1989. However, the treatment landscape has undergone its first major changes in the past 30 years with the emergence of vonoprazan (Voquezna).A novel, first-in-class small molecule potassium-competitive acid blocker (PCAB), vonoprazan now boasts 3 US Food and Drug Administration (FDA) approvals across both erosive and non-erosive GERD. Less than a year after earning approval for the healing and maintenance of healing of all grades of erosive GERD as well as the relief of heartburn associated with erosive GERD, vonoprazan has also been approved for the treatment of heartburn in non-erosive GERD.

Led by a flood of biologic therapies becoming available and progressing within the therapeutic pipeline, the field of dermatology finds itself in the midst of a watershed moment for many dermatologic conditions. To celebrate and recap the advancements occurring in the first half of 2024, the editorial team of HCPLive Dermatology sat down with James Del Rosso, DO, research director of JDR Dermatology Research and president of the American Acne and Rosacea Society, for more perspective on pipeline movement.Del Rosso, who also serves as an adjunct clinical professor of Dermatology at Touro University, takes a deep dive into several different disease states in dermatology and highlights how the news to emerge in the last 6 months, as well as prior to the close of 2023, has influenced real-world management.

In the latest episode of New Insight with Veeral Sheth, MD, host Veeral Sheth, MD, director of clinical research at University Retina, speaks with Seemi Khan, chief medical officer at Alkeus Pharmaceuticals, on the company’s lead candidate being evaluated in clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Gildeuretinol is a novel molecule designed as a specialized form of deuterated vitamin A to reduce the dimerization of vitamin A without disrupting vision. The therapy has received Breakthrough and Orphan Drug designations from the US Food and Drug Administration (FDA). Listen to the conversation between experts on Khan’s background in the pharmaceutical industry, including time spent at Abbott, Abbvie, and Quark Pharmaceuticals, her experience bringing treatments to patients with rare diseases, and the impressive data from gildeuretinol in the TEASE clinical trial program for a currently unmet need.Episode Highlights0:07 Episode Intro0:57 Seemi Khan's background4:38 Mechanism of action of gildeuretinol7:22 Patient populations9:00 TEASE clinical trial program14:37 Gildeuretinol in GA16:32 Safety data18:47 Next steps for Alkeus22:28 ConclusionCheck out more ophthalmology coverage at HCPLive.com!

Since the mid-20th century ushered in the ‘Information Age’, a desire for innovation has driven the pursuit of technological advancements. Many may immediately consider the transformations personal computers and smartphones have had on modern society, but these advancements have transformed the fields of medicine time and time again. In the latest episode of New Insight with Veeral Sheth, MD, Michael Freeman, the chief executive officer of Ocutrx, joins Dr. Sheth to discuss the history of Ocutrx, its OcuLez and OR-Bot products, and what he envisions in the next decade at the company.Episode Highlights0:06 Introduction1:22 History of Ocutrx9:05 A look at the Oculenz18:27 Introduction of a caretaker app19:26 A look at the OR-Bot25:55 Envisioning the next decade at Ocutrx29:02 ConclusionEvery episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at [email protected].

Episode Highlights: 0:16 Intro 0:28 Overview of presentation 0:38 Acne and post-inflammatory hyperpigmentation 01:35 Approaches to take 03:21 Rosacea, use of dermoscopy and symptomatology assessment 04:59 Necessity of inclusivity in clinical trials, other knowledge gaps 06:05 Images used in education The American Academy of Dermatology (AAD) Annual Meeting in 2024 featured Dr. Andrew Alexis, a prominent figure in dermatology. Dr. Alexis, currently serving as the vice-chair for diversity in the department of dermatology and a professor of clinical dermatology at Weill Cornell Medical College in New York, presented a talk titled "Controversies in Acne and Rosacea." In the interview, he shed light on critical aspects of managing acne and rosacea, particularly focusing on patients with skin of color. Dr. Alexis advocated for inclusivity in clinical trials to improve understanding across diverse patient populations. He stressed the importance of expanding public awareness of rosacea in communities with skin of color and suggested incorporating diverse images into educational materials to better represent the spectrum of affected individuals. Dr. Alexis's insights underscore the necessity of tailored approaches and increased inclusivity in dermatological research and education to better serve patients with diverse skin tones and backgrounds. For additional information covered at the 2024 AAD conference, visit us at: https://www.hcplive.com/conference/aad.

In the medical community, a revolving cast of players plays a pivotal role in advancing scientific discovery and enhancing patient outcomes. During the research stage, a collaborative team effort, from the clinical trial sponsors to research sites and patient populations, is essential to ensure smooth progress and sustain momentum toward the finish line. The latest episode of New Insight with Veeral Sheth, MD features a conversation with Brad Doerschuk, the CEO of InFocus Clinical Research, on the important role of contract research organizations (CROs) in retina and the field of ophthalmology.In their conversation, Sheth and Doerschuk shed light on the role of CROs in managing clinical trials, dive into the evolution of the retina space in recent decades, and describe the challenges in recruiting for trials of new agents.Episode Highlights0:00 Introduction0:52 What is a CRO?2:13 Development of InFocus6:45 Discussing the retina pipeline11:46 Recruitment challenges, solutions15:50 Developing new clinical trial sites18:19 Relationship between investigators, CROs19:56 Shift in FDA guidance23:14 New trial endpoints25:16 ConclusionEvery episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at [email protected].

A special double-episode of New Insight with Veeral Sheth, MD features a well-rounded conversation on all things ophthalmology with returning guest David Eichenbaum, MD, the director of research for Retina Vitreous Associates of Florida, as well as first-time guest Roger Goldberg, MD, a vitreoretinal surgeon at Bay Area Retina Associates.The trio of retina specialists discuss recent conference news, the anniversary of a landmark agent, and what’s to come in 2024 for the specialty.Episode Highlights: 0:00 Introduction1:25 Entering 20247:34 The importance of treatment efficacy 12:09 Re-engaging GA treatment15:05 Comparing aflibercept 8 mg and faricimab23:00 Real-world data sets26:30 What’s to come in 202427:45 Intravitreal gene therapies 31:00 Port delivery system 36:00 Wrapping-up Every episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at [email protected].

In every episode of New Insight, Veeral Sheth, MD, Director of Clinical Trials at University Retina in Chicago, takes an in-depth look at the biggest news in ophthalmology and the behind the scenes work involved in eye care, with a rotation of guest experts involved in ophthalmic research, development, and clinical care. The latest episode of New Insight features a conversation with Ocuphire Pharma’s CEO on the company’s flagship retinal product and leading a small, but high-powered research team. Episode Highlights: 0:04 Introduction1:23 History of Ocuphire Pharma3:50 Leading a small, high-functioning team6:41 Magrath’s background and journey 11:02 APX3330 for Diabetic Retinopathy15:20 2024 Plans for Ocuphire18:53 Addressing unmet needs20:20 OutroEvery episode of New Insight is available on HCPLive.com and be sure to subscribe to our channel on Spotify and Apple Podcasts. Please direct any podcast-related inquiries to show producer Connor Iapoce at [email protected].

On the floor at AAO 2023, host Veeral Sheth, MD, and producer Connor Iapoce discuss UBX1325 for patients with diabetic macular edema, based on the 48-week results from the phase 2 BEHOLD study. Episode Highlights:0:30 Introduction0:48 Background into UBX1325 and BEHOLD2:49 BEHOLD 48-week results6:05 Next steps6:56 ConclusionPlease direct any podcast-related inquiries to [email protected].

Episode Highlights 0:12 Intro 1:24 Challenges in autoimmune hepatitis 3:30 Patient demographics 4:25 Diagnostic challenges 6:35 What is overlap syndrome? 8:04 Mysteries behind immune dysregulation 9:05 Promising drugs in investigation 10:51 The BAFF receptor target 11:41 Infliximab & rituximab 12:38 An autoimmune hepatitis wishlist 15:29 Outro Autoimmune hepatitis (AIH), a rare liver disease characterized by an unclear driver of inflammation, is historically challenged by limited clinical understanding, a slow development of treatment options in investigation, and a nonetheless concerning prognosis for affected adults and children. While some prospects are in development to aid specialists in adequately identifying risk factors for, diagnosing and treating AIH, education and communication on those developments is vital. In an interview with HCPLive during the American College of Gastroenterology (ACG 2023) Annual Scientific Meeting in Vancouver, BC this week, Gina Choi, MD, associator clinical professor of medicine and surgery at UCLA Health, discussed the ins and outs of modern autoimmune liver disease research and development. Including the treatment pipeline and current standards for diagnostics, Choi additionally discussed the sociodemographic and pathophysiological traits of AIH burden—as well as the lesser-known overlap syndrome. For more hepatology and gastroenterology coverage from ACG 2023, visit us at https://www.hcplive.com/conference/acg.

Host Veeral Sheth, MD is joined by Megan Baldwin, PhD, CEO and Managing Director of Opthea Limited, to discuss OPT-302 or sozinibercept, the company's novel anti-VEGF-C / VEGF-D treatment for wet AMD and other retinal diseases.Episode Highlights:0:06 Introduction0:37 Background of Dr. Baldwin9:56 Promising data on OPT-302/sozinibercept16:39 Making decisions as a clinician, industry leader22:11 Future of the treatment landscape28:24 What’s next for Opthea?32:39 ConclusionPlease direct any podcast-related inquiries to [email protected].

Warren Jones, PhD, scientific founder of EarliTec Diagnostics and autism expert, discusses his team's development of an eye-tracking device recently authorized by the FDA and proven in clinical trials to predict autism consistent with expert diagnoses.

After a historically low-transmission summer, new cases, hospitalizations and deaths due to COVID-19 have increased by approximately 18% in the US over the last week, according to CDC data. In a new DocTalk interview, Donald J. Alcendor, PhD, associate professor, department of pathology microbiology and immunology, division of infectious diseases, Vanderbilt University Medical Center, and HCPLive Editorial Advisory Board member, discussed the factors influencing the current iteration of COVID-19 in the US. Put briefly: “The virus is changing, and immunity is waning.” Want more COVID-19 and health care news updates? Visit us at HCPLive.com.Episode highlights:0:16 Intro1:36 The current climb in COVID-19: What’s happening?3:58 Are the variants becoming harder to dodge?7:01 How the end of the US public health emergency impacted prevention11:07 Realistic vaccine expectations13:13 Advancing COVID-19 antivirals17:32 The future for mRNA vaccines infectious disease21:27 Public health implications22:58 A quiet COVID-19 summer: What went well?25:06 Projecting future waves28:26 Advice for clinicians in preparing patients

In this episode, host Veeral Sheth, MD, and producer Connor Iapoce discuss 5 important presentations from ASRS 2023. The discussion centers around new data on geographic atrophy therapies, novel agents for DME, and the feasibility of home OCT. Please direct any podcast-related inquiries to [email protected].

The newest episode of New Insight with Veeral Sheth, MD features a conversation with David Eichenbaum, MD, the director of research for Retina Vitreous Associates of Florida. A seasoned clinical trial investigator and a friendly face at major medical meetings, Eichenbaum provides insights into his goals behind mentorship and inspiring others, sharing anecdotes about his own journey. On the heels of an already busy year, the experts discuss evolutions in the field and the pipeline, as the retina landscape changes each calendar month. In this vein, the two specialists discuss their ever-changing roles from investigators to mentors to stewards for the next generation of retina specialists. Please direct any podcast-related inquiries to show producer Connor Iapoce at [email protected].

In the latest episode of New Insight, Veeral Sheth, MD sat down with Cedric Francois, MD, PhD, co-founder and chief executive officer/president of Apellis Pharmaceuticals. The two experts discussed the company's landmark therapy, pegcetacoplan (SYFOVRE™), for geographic atrophy and the decades-long journey toward FDA approval. Sheth also asked about Francois' evolving role in the company and the interplay between being a scientist, clinician, and corporate executive. The experts also touched on how the GA treatment landscape might evolve over the next few years and what will shape the future of retina. Please direct any podcast-related inquiries to [email protected].

In this episode, Veeral Sheth, MD, sits down with Jay Duker, MD, the president and chief operating officer of Eyepoint Pharmaceuticals, for a discussion on his storied career in ophthalmology, the importance of fostering a relationship between clinicians and industry, and the current biotech Dr. Duker and team are working on at Eyepoint. Please direct any podcast-related inquiries to [email protected].

In this episode, Charles Wykoff, MD, PhD joins Dr. Sheth to provide insight into the recent landmark approval of pegcetacoplan injection (SYFOVRE™) for geographic atrophy, how clinical practice has changed as a result, and both the early struggles with and optimism for an ever-changing treatment landscape. Please direct any podcast-related inquiries to [email protected].

As part of our ARVO 2023 coverage, Dr. Sheth sat down with Pravin Dugel, MD, President of Iveric Bio. Together, the experts discussed the lead molecule for the company, avacincaptad pegol for geographic atrophy, and touched on the data being presented at the conference, as well as a look back at Dugel's career and his transition into industry.

The inaugural episode of New Insight with Veeral Sheth, MD, our premier ophthalmology-focused podcast, features a conversation with Arshad Khanai, MD, the Director of Clinical Research at Sierra Eye Associates in Reno, Nevada. Together, our experts discuss their background and education in retina, and how they started working on clinical trials. They go on to describe the work that has led to recent landmark drug approvals in ophthalmology, including faricimab and pegcetacoplan, and the impact of these treatments on patients. Friends and colleagues for nearly 20 years, Sheth and Khanani talk a bit about their history, what mentorship means in medicine and their role as mentors to fellows and younger colleagues within the space. Lastly, the two KOLs discuss what they are looking forward to in the year, with particular mention of upcoming meetings and developments that may define the year 2023. We hope you enjoy our first episode! Keep an eye out for more from New Insight.

The latest offering from HCPLive Podcasts is New InSight with Veeral Sheth, MD, an in-depth series examining the biggest news in ophthalmology. The podcast will feature conversations on research news and new therapies, landmark findings from major medical meetings, and the day-to-day life of an ophthalmologist in the 21st century. A range of guests will join Dr. Sheth to share perspective and provide new insight into an ever-changing and ever-growing field. Stay tuned for our first episodes set to be released in April. But, for now, enjoy this first look at New InSight!

Lawrence Eichenfield, MD, reviews major drug approvals and advancement of screening and prevention strategies for the youngest patients with atopic dermatitis.

As 2022 concludes, a dermatologist reflects on the first drug approved for vitiligo.

Dr. Lally of New England Retina Consultants joins to discuss avacincaptad pegol, a promising injection treatment for GA, and its supporting data from the GATHER trial program. Will the complement C5 inhibitor drug receive FDA approval in 2023? Lally discusses this and more on the latest DocTalk.

Ahead of the American College of Rheumatology 2022 Convergence meeting on Nov. 10-14, our editorial team sat down with planning committee member Zsuzsanna McMahan, MD, MHS, of Johns Hopkins University School of Medicine, to take a deep dive into the upcoming meeting.

The FDA is expected to announce the final decision for the dual therapy AT-GAA, which uses miglustat in combination with cipaglucosidase alfa for treating Pompe disease, an inherited and often times fatal disorder. Expert Barry Byrne discusses the characteristics of the condition and what this FDA decision will mean for treatment.

One of the most notable topics discussed at the 2022 American Academy of Ophthalmology Meeting in Chicago was new advancements in geographic atrophy (GA) treatment. A form of advanced age-related macular degeneration (AMD), there are no currently available treatments for the debilitating disease. In this episode of DocTalk, we spoke with Arshad Khanani, MD, Director of Clinical Research, Sierra Eye Associates, on the findings from the GATHER2 trial on avacincaptad pegol for the treatment of GA. Throughout our conversation, Khanani laid out the first-time efficacy results of the phase 3 trial and its patient population, the overall safety of the agent, and what it might mean to alleviate the biggest unmet need in retina today. We hope you enjoy. If you are interested in more content from AAO 2022 or our ophthalmology coverage, visit us at HCPLive.

In the wake of Newborn Screening Awareness Month, this episode dives into a novel diagnostic precision medicine guidance tool called BeginNGS. Catherine Nester, RN, and Dr. Stephen Kingsmore, discuss the pivotal role of newborn screening in diagnosing rare diseases. As representatives from collaborating partners Inozyme Pharma and Rady Children's Institute that created this tool, they explain the impact that BeginNGS can have on the future of rare disease medicine.

Martha Gulati, MD, Director of Preventive Cardiology, Associate Director of the Barbara Streisand Women’s Heart Center, Associate Director of Preventive and Cardiac Rehabilitation at Cedars-Sinai Medical Center, joins Heart Team to discuss current challenges in women’s cardiovascular disease research and clinical advancement. Gulati also provides guidance on improving female trial enrollment strategies and patient recruitment, and her thoughts on clinician perception of cardiovascular symptoms in men versus women. Heart Team is a monthly multimedia series hosted by Jorge Plutzky, MD, Director of Preventive Cardiology at Harvard Medical School, and Michael Farkouh, MD, Director of the Peter Munk Clinical Trials Unit and Vice Chair of Medicine at the University of Toronto. Watch the video of this interview, with more insights from Dr. Plutzky and Dr. Farkouh, at HCPLive.com.

In the first episode from this new cardiovascular medicine series, hosts Dr. Jorge Plutzky and Dr. Michael Farkouh speak with University of Maryland's Dr. Matthew Weir about the growing involvement of renal care in modern heart disease patients.

The second episode of the 2-part Rare Disease Report shifts to a clinical perspective with the expertise of Dr. Pestana, a pediatric epileptologist at the Epilepsy Center, Cleveland Clinic Neurological Institute who treats patients with CDKL5 deficiency disorder (CDD).

In the first episode of a 2-part Rare Disease Report, Whitney Mitchell, mother and caregiver to her 6 year old daughter Havilah, shared her experience leading up to, and now living with, Havilah’s CDKL5 deficiency disorder (CDD) diagnosis.