Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

The United States Food and Drug Administration (US FDA) has granted accelerated approval to lunsotogene parvec-cwha (Otarmeni) for severe-to-profound and profound sensorineural hearing loss associated with biallelic 

 variants, marking the first FDA-approved gene therapy for a genetic form of hearing loss and, according to the company, the first approved gene therapy intended to restore a neurosensory function to normal levels.

 For clinicians, the decision introduces a new option for a narrowly defined population in whom treatment has largely centered on hearing devices and cochlear implantation rather than molecular correction of the underlying defect.

Approval was based on 24-week findings from the ongoing phase 1/2 CHORD study, an open-label multicenter trial enrolling infants, children, and adolescents with 

-related hearing loss. The indication includes pediatric and adult patients with molecularly confirmed biallelic 

 variants, preserved outer hair cell function, and no prior cochlear implant in the same ear.^1

“The FDA approval of Otarmeni signals a new era in the treatment of genetic forms of hearing loss, where reinstating 24/7 natural hearing is now possible,” investigator A. Eliot Shearer, MD, PhD, otolaryngologist in the department of Otolaryngology and Communication Enhancement at Boston Children’s Hospital, Associate Professor of Otolaryngology-Head and Neck Surgery at Harvard Medical School, said in a statement.

 “In the pivotal trial, the one-time gene therapy demonstrated rapid, meaningful and consistent hearing responses, with most children achieving remarkable hearing improvements. I’ve witnessed firsthand my trial participant responding to their mother’s voice, dancing to music and interacting with the world, and these moments are now possible for more children born with this specific form of hearing loss.”

 encodes otoferlin, a protein required for synaptic transmission between inner hair cells and the auditory nerve. Pathogenic variants typically cause auditory neuropathy spectrum disorder or congenital severe hearing loss despite structurally intact cochlear hair cells, making the disorder an attractive target for gene replacement strategies.

 The approved product is an adeno-associated virus vector–based therapy delivered by intracochlear infusion under general anesthesia, using a surgical approach similar to cochlear implantation.

In CHORD, 20 participants aged 10 months to 16 years received a single dose either unilaterally (n = 10) or bilaterally (n = 10).

 All had profound hearing loss by behavioral pure tone audiometry (PTA) at baseline and lacked auditory brainstem response (ABR) at maximum sound levels, according to the release. The primary end point was improvement in hearing sensitivity by average PTA at week 24.

Among the 20 treated participants, 16 (80%) reached a hearing threshold of 70 dB hearing level or better at 24 weeks, meeting the primary end point; 1 additional participant met that threshold by week 48.

On the key secondary end point, 14 participants (70%) demonstrated ABR at 90 dB or less by week 24. In longer-term follow-up, all prior responders reportedly maintained response, and 5 of 12 participants (42%) with 48-week follow-up achieved hearing thresholds of 25 dB or less, which the company described as normal hearing including whispers.

 Because approval is accelerated, continued approval may depend on confirmatory evidence from the ongoing CHORD trial.

Safety findings should be interpreted in the context of both the gene therapy and the required otologic procedure. In the CHORD safety population (n = 24), the most common adverse reactions, each reported in at least 5%, were otitis media, vomiting, nausea, dizziness, procedural pain, gait disturbance, and nystagmus.

The prescribing information summarized in the release also notes risks associated with inner ear surgery, including vertigo, tinnitus, cerebrospinal fluid leak, facial weakness, meningitis, mastoiditis, wound infection, and labyrinthitis. The therapy is not recommended when preoperative imaging suggests that access to the inner ear is not feasible, including abnormal mastoid pneumatization or clinically significant anatomic variation.

The clinical relevance of the approval lies partly in the limitations of current management. Hearing aids may amplify sound but do not correct synaptic transmission defects, and cochlear implantation—while often beneficial in 

-related deafness—requires an implanted device and long-term hardware dependence.

Whether gene replacement will alter long-term language acquisition, developmental outcomes, bilateral hearing function, or the timing and need for cochlear implantation remains to be established in larger cohorts with longer follow-up.

The company said it will provide the therapy at no cost in the US, although administration-related costs may still apply.

 That access model is unusual, but it does not change the narrow regulatory scope of the approval or the practical requirement for specialized surgical centers. Regulatory submissions are planned outside the US; the European Medicines Agency has granted orphan designation, but no approval was reported in Europe.

The main limitations of the current evidence are the small sample size, open-label design, mixed unilateral and bilateral treatment cohorts, and reliance on surrogate and intermediate auditory end points at an early time point. Even so, the approval establishes a regulatory pathway for inner ear gene therapy and will likely intensify interest in genotype-specific treatment strategies for hereditary hearing loss.

Regeneron Pharmaceuticals, Inc. Otarmeni (lunsotogene parvec-cwha) approved by FDA as first and only gene therapy for genetic hearing loss; Regeneron to provide Otarmeni for free in the U.S. GlobeNewswire. April 23, 2026. Accessed April 23, 2026. 

https://www.globenewswire.com/news-release/2026/04/23/3280270/0/en/otarmeni-lunsotogene-parvec-cwha-approved-by-fda-as-first-and-only-gene-therapy-for-genetic-hearing-loss-regeneron-to-provide-otarmeni-for-free-in-the-u-s.html

Shearer AE, Smith RJH. Massively parallel sequencing for genetic diagnosis of hearing loss: the new standard of care. Otolaryngol Head Neck Surg. 2015;153(2):175-182.

Delmaghani S, El-Amraoui A. Inner ear gene therapies take off: advances for monogenic forms of deafness. Hum Mol Genet. 2020;29(R1):R80-R88.

Articles

US FDA accelerated approval of lunsotogene parvec-cwha (Otarmeni), an AAV intracochlear gene replacement therapy for biallelic OTOF-related severe-to-profound sensorineural hearing loss, establishes the first approved gene therapy for genetic deafness and aims to restore physiologic auditory function. In the phase 1/2 CHORD trial, most pediatric participants achieved clinically meaningful improvements in PTA and ABR by 24 weeks, with some reaching thresholds consistent with normal hearing by 48 weeks. Durability, developmental impact, and long-term safety require confirmation.

FDA approved lunsotogene parvec for OTOF-related hearing loss based on phase 1/2 data showing improved hearing in a small cohort.

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FDA Approves Lunsotogene Parvec for OTOF-Related Genetic Hearing Loss

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Christie Polycarpe, DO | Image Credit: American Association of Clinical Endocrinology

, the use of GLP-1 receptor agonists was associated with a statistically significant reduction in the risk of several end-organ complications, according to a retrospective cohort analysis.

, their effects on patients with T1D have not been substantially explored. Recent research has demonstrated GLP-1s’ efficacy in conjunction with automatic insulin delivery systems, showing substantial improvements in time in range. However, the broader effects of this medication class, including its effects on many end-organ complications such as diabetic retinopathy and renal disease, are not well-known and do not possess significant evidence to support an indication.

American Association of Clinical Endocrinology (AACE) Annual Meeting 2026

 in Las Vegas, Nevada, by Christie Polycarpe, DO, department of internal medicine, Jefferson Einstein Medical Center, the present data emphasize the rapidly growing safety data supporting the use of GLP-1s in T1D.

“Emerging evidence suggests GLP-1 RAs may protect patients with T2DM from end-organ complications, such as major cardiac events and CKD,” Polycarpe and colleagues wrote. “The potential of GLP-1 RAs to help prevent these complications in T1DM remains understudied, likely because insulin is central to T1DM management.”

Polycarpe and colleagues collected data from the TriNetX Global Collaborative Network, establishing 2 primary cohorts: patients with T1DM who had received GLP-1 RAs (Cohort 1: n = 133,782) and those who had not (Cohort 2: n = 985,724). Propensity score matching for vital signs, body mass index, and bloodwork ultimately narrowed the cohorts to 130,453 patients each. The study’s primary outcomes were renal disease, diabetic retinopathy, diabetic neuropathy, and atherosclerotic disease.

The team ultimately found that the use of GLP-1 RAs in patients with T1DM was associated with a small but statistically significant reduction in the risk of all 4 outcomes compared to those who did not receive treatment. However, patients who did not receive GLP-1 RAs showed a small but significantly lower risk of atherosclerotic disease. Polycarpe and colleagues acknowledge that this could be a result of temporal bias, wherein patients receiving GLP-1 RAs could potentially have pre-existing cardiovascular disease risk and are receiving the medication for cardiovascular benefit in addition to diabetes.

Investigators also highlighted several potential mechanisms behind this protective effect, including direct anti-inflammatory actions on micro- and macrovasculature, improved glycemic control, reducing exogenous insulin needs, thereby decreasing glycemic variability and endothelial stress, and reduced visceral adipose tissue, which could lower vascular inflammation indirectly.

Polycarpe and colleagues also noted limitations inherent in their study’s design, including the risk of inaccuracies in ICD coding, a lack of matching for socioeconomic factors that could confound the results, and the inability to verify duration or adherence to GLP-1 RA treatment after prescription. To that end, the team calls for further research.

“Further prospective studies and clinical trials are needed to validate our findings,” Polycarpe and colleagues wrote.

Polycarpe C, Gadalla K, Rodriguez A. Impact of GLP-1 Receptor Agonists on End-Organ Complications in Type 1 Diabetes: A Retrospective Cohort Analysis. Abstract presented at the American Association of Clinical Endocrinology Annual Meeting 2026, Las Vegas, NV. April 22-24, 2026.

Shah VN, Akturk HK, Kruger D, et al. Semaglutide in Adults with Type 1 Diabetes and Obesity. 

Use of GLP-1 receptor agonists in type 1 diabetes was associated with statistically significant risk reductions across renal disease, diabetic retinopathy, diabetic neuropathy, and atherosclerotic disease in a large, propensity-matched TriNetX retrospective cohort. A paradoxical signal showed slightly lower atherosclerotic risk in nonusers, potentially reflecting temporal bias and higher baseline cardiovascular risk among treated patients. Proposed biologic explanations include anti-inflammatory vascular effects, improved glycemic control with reduced insulin requirements and variability, and decreased visceral adiposity. Key limitations include ICD coding accuracy, unmeasured socioeconomic confounding, and uncertain adherence.

Recent data presented at AACE 2026 have indicated the efficacy of GLP-1 RA treatment in reducing risk of diabetic retinopathy, renal disease, and others.

Endocrinology

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GLP-1 RAs Improve End-Organ Complications in Patients With Type 1 Diabetes

Guidance for Clinicians on Patient Questions About Psychedelics, With Gus Alva, MD

General clinicians should take patient questions about psychedelic therapies seriously and respond with balanced, nonjudgmental information, even if they lack detailed expertise, according to Gus Alva, MD, psychiatrist and medical director of ATP Clinical Research. He emphasized that inquiries often reflect unmet treatment needs rather than curiosity alone.

“It's really important that if a clinician just dismisses the question, they might then push the patient towards [a] less safe, unsupervised route, and that would be catastrophic in and of itself,” Alva told 

. “It's important for generalists also to know what is approved versus what is experimental.”

He cited ketamine, which is used off-label for treatment-resistant depression, and intranasal esketamine (Spravato), which has received approval from the Food and Drug Administration (FDA) under a Risk Evaluation and Mitigation Strategy. In contrast, agents such as psilocybin, MDMA, LSD, DMT, and ibogaine remain investigational and are generally accessible only through clinical trials or limited research settings.

He encouraged clinicians to screen for features that may increase risk, including histories of bipolar disorder, psychosis, or cardiovascular disease, when patients express interest in psychedelic therapies. These considerations are particularly relevant given reports of patients seeking treatment through retreat centers or other unregulated providers, he said.

“That would actually expose individuals to additional risks,” Alva noted.

Alva also recommended that generalists familiarize themselves with local research programs and referral pathways. Although most clinicians will not deliver psychedelic-assisted therapy, awareness of legitimate clinical trial options can help guide patients appropriately. He emphasized that many individuals pursuing these therapies have experienced partial response or failure with standard treatments, including antidepressants or psychotherapy, and may have higher symptom burden.

Providing clear, evidence-based information while acknowledging uncertainty may help clinicians support patient decision-making. According to Alva, clinicians should focus on understanding why patients are interested, assessing safety considerations, and maintaining open communication. He added that this approach can help strengthen trust while ensuring that patients receive guidance grounded in current evidence and regulatory status.

spoke with Alva in light of the White House executive order issued on April 18, 2026, that directs federal agencies to accelerate psychedelic research for serious mental illness.

 The order, signed by President Donald Trump, outlines steps for prioritizing review of psychedelic compounds, facilitating access under the Right to Try framework, and supporting collaborative research efforts involving federal agencies, academic centers, and the private sector. With federal efforts accelerating psychedelic research, the field may be moving closer to establishing these agents as therapeutic options for patients with mental illness.

“It doesn't mean that every generalist is going to have to become now a psychedelic expert or therapist or clinician, but we should be able to figure out why [our] patients [are] asking about it who have high-risk features and provide non-judgmental information, as well as referring appropriately,” Alva said. “[This] subsequently will help strengthen the therapeutic relationship of the individual with their provider.”

Watch parts 1 and 2 of our interview with Alva here: 

White House Order Accelerates Psychedelic Research for Mental Illness, With Gus Alva, MD

Psychiatry Infrastructure Lags Psychedelic Momentum, With Gus Alva, MD

Relevant disclosures for Alva include Teva Pharmaceuticals, Otsuka America Pharmaceuticals, AbbVie Inc., Axsome Therapeutics, Janssen Pharmaceuticals, and more.

O’Neil G. Accelerating Medical Treatments for Serious Mental Illness. The White House. Published on April 18, 2026. Accessed April 20, 2026. 

https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/

Kotkiewicz J. Fact Sheet: President Donald J. Trump is Accelerating Medical Treatments for Serious Mental Illness. The White House. Published April 18, 2026. 

https://www.whitehouse.gov/fact-sheets/2026/04/fact-sheet-president-donald-j-trump-is-accelerating-medical-treatments-for-serious-mental-illness/

Videos

Alva outlines how general clinicians should address patient questions on psychedelic therapies, including risks, approvals, and referral pathways.


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Rory Sayres, PhD, is a researcher in the Health AI group in Google Research who focuses on intelligence augmentation of medical experts using machine-learning-based assistance.

Yun Liu, PhD, is a senior staff research scientist at Google Health/Research, focused on developing and validating machine learning models for medical imaging, including pathology, dermatology, and ophthalmology.

Patient Awareness of Dermatologic Conditions Using AI, With Rory Sayres, PhD, and Yun Liu, PhD

, Rory Sayres, MD, and Yun Liu, PhD, of Google Research, went into greater depth about the implications of their recent 

 study, focusing on how artificial intelligence (AI)-generated information is interpreted by consumers and what improvements may be needed to better support clinical decision-making.

A key theme in this video segment was the gap noted by the 2 speakers between improved condition recognition and limited gains in understanding appropriate next steps. While AI tools can meaningfully increase a user’s ability to identify a likely skin condition, Sayres expressed, translating this recognition into actionable decisions, such as whether to seek care, remains more complex. Such a disconnect, he noted, is consistent with prior data observed on use of online health information, suggesting influencing behavior is inherently more difficult than improving knowledge alone.

“There are definitely a lot of diseases [in ophthalmology], but when an ophthalmologist is looking at like an image of a retina, that number of possible diseases is somewhat smaller,” Sayres explained. “Whereas when you look at dermatology, one of the first things we saw is the set of conditions you might want to assess for numbers at least in the hundreds.”

The investigators emphasized that accuracy of the underlying AI predictions plays a critical role in shaping outcomes. The study’s “Wizard of Oz” arm, which presented dermatologist-generated differentials, demonstrated stronger improvements in next-step decision-making compared with the AI arm. This finding highlights that even modest gaps in prediction quality can influence how users interpret and act on information. Liu noted that improving the precision and ranking of suggested conditions may therefore be an important step toward enhancing the clinical usefulness of these tools.

Outside of prediction accuracy, the 2 speakers pointed to the value of how information is presented to users. In their study design, they included structured condition “cards” with images, descriptions, and treatment information, but their results indicate the providing of more data is not sufficient. Instead, Sayres indicated future iterations of AI tools may require guiding users through decision-making processes, potentially by providing them with more apparent recommendations or contextual cues regarding the level of severity and urgency.

In their discussion, Liu and Sayres also touched on user behavior and variability in how individuals act on their health information. Participants brought differing levels of prior knowledge, interpretation strategies, and confidence, all of which can impact patient outcomes regardless of the use of AI tools. As a result, the 2 investigators describe optimizing user experience and interface design as just as necessary as algorithmic accuracy improvements.

Looking ahead, Sayres and Liu noted the promise held by AI tools as adjuncts to, not replacements for, clinical care. Although current data support their role in improving consumer understanding of skin conditions, further refinement was described necessary to ensure these technologies can reliably guide patients toward appropriate next steps.

The quotes contained in this summary were edited for the purposes of clarity.

Disclosures: Sayres and Liu reported stock ownership from Google outside the submitted work.

GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8. Erratum in: Lancet. 2019 Jun 22;393(10190):e44. 

Sayres R, Jain A, Liu Y, et al. Consumer Understanding of Skin Concerns With an AI-Powered Informational Tool. JAMA Dermatol. 2026 Apr 15:e260597. 

. Epub ahead of print. PMID: 41984449; PMCID: PMC13084546.

Liu and Sayres emphasize that while AI tools improve consumer recognition of skin conditions, gaps remain in prediction accuracy and information.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

IBI311 Efficacious and Safe in Reducing Proptosis in Thyroid Eye Disease | Image Credit: Pexels

IBI311, an insulin-like growth factor 1 receptor (IGF-1R) inhibitor, has successfully improved proptosis and disease activity in patients with moderate-to-severe 

 who responded poorly to glucocorticoid therapy.

 in Las Vegas, Nevada, by Xiuying Zhang, PhD, department of endocrinology and metabolism, Peking University People’s Hospital, followed up the phase 3 RESTORE-1 study in China, which saw IBI311 (teprotumumab N01) demonstrate promising results in TED.

The present study was a randomized, double-masked, placebo-controlled clinical trial, enrolling patients between 18 and 80 years and with a weight between 45 and 100 kg (99 and 220.5 lb). Additionally, patients were required to have a clinical diagnosis of Graves’ disease associated with active TED, with a Clinical Activity Score (CAS) ≥3 for ≥1 eye at screening and baseline, as well as moderate-severe active TED. Patients with optimal corrected vision loss due to optic neuropathy, corneal ulcers, or baseline CAS decreased by >2 points versus screening, among other criteria, were excluded.

Following enrollment, patients were stratified by baseline activity and randomly assigned in a 2:1 ratio to receive either IBI311 or placebo. Both treatments were given every 3 weeks for 4 infusions of 10mg/kg at day 1 and 20 mg/kg at weeks 3, 6, and 9. Patients were then evaluated at week 12, after which both arms were given another 4 infusions of IBI311 from week 12 to 21.

The study’s primary outcome was proptosis responder rate of the study eye, which was defined as the percentage of patients with a ≥2 mm reduction from baseline in proptosis without deterioration proptosis in the non-study eye. Secondary outcomes included the overall responder rate in the study eye, the percentage of subjects with a CAS value of 0 or 1 in the study eye, and the mean change from baseline in proptosis measurement, among others.

A total of 53 patients were included in the study, of whom 36 received IBI311 and 17 received placebo. Baseline characteristics were relatively balanced across both arms. By week 12, proptosis response was substantially higher with IBI311 than with placebo (58.3% vs 29.4%; 

 = .034). The IBI311 group also demonstrated greater mean reductions in proptosis (-2.28 vs -0.77 mm; 

Patients with active TED in the IBI311 arm achieved a superior overall response rate (46.2% vs 16.7%; 

 = .043), and a higher proportion of patients reached a CAS of 0 or 1 in the IBI311 arm. Diplopia response was numerically higher in the IBI311 arm. After transitioning from placebo to IBI311, patients in both arms saw sustained and further improved therapeutic benefits through week 24.

“In participants with moderate-to-severe TED with poor response to glucocorticoid therapy, IBI311 demonstrated significant efficacy in improving proptosis and disease activity and was well tolerated,” Zhang and colleagues wrote. “These findings support IGF-1R inhibitors as a promising treatment option for this population with unmet clinical need.”

Zhang XY, Zhao W, Li TY, et al. Efficacy and Safety of IBI311 in Thyroid Eye Disease (TED) Poorly Responsive to Glucocorticoids: A Randomized, Double-Masked, Placebo-Controlled Trial. Abstract presented at the American Association of Clinical Endocrinology Annual Meeting 2026, Las Vegas, NV. April 22-24, 2026.

Innovent Biologics (Suzhou) Co. Ltd. A Study of IBI311 in Subjects With Active Thyroid Eye Disease. ClinicalTrials.gov Identifier: NCT05795621. Updated February 8, 2024. Accessed April 22, 2026. 

https://clinicaltrials.gov/study/NCT05795621

IBI311, an IGF-1R inhibitor (teprotumumab N01), showed clinically meaningful improvements in moderate-to-severe active thyroid eye disease refractory to glucocorticoids. In a randomized, double-masked, placebo-controlled trial (n=53; 2:1 allocation), IBI311 produced higher week-12 proptosis responder rates and greater reductions in proptosis and Clinical Activity Score than placebo. Additional benefits were observed in overall response and attainment of low disease activity (CAS 0–1), with numerically improved diplopia. After crossover to active therapy, responses were sustained through week 24 with acceptable tolerability.

A recent study presented at AACE 2026 has displayed the IGF-1R’s capacity for improving proptosis and disease activity in patients with poorly-controlled TED.

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IBI311 Efficacious and Safe in Reducing Proptosis in Thyroid Eye Disease

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She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

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Latest News

FDA Approves Lunsotogene Parvec for OTOF-Related Genetic Hearing Loss

GLP-1 RAs Improve End-Organ Complications in Patients With Type 1 Diabetes

Guidance for Clinicians on Patient Questions About Psychedelics, With Gus Alva, MD

Patient Awareness of Dermatologic Conditions Using AI, With Rory Sayres, PhD, and Yun Liu, PhD

IBI311 Efficacious and Safe in Reducing Proptosis in Thyroid Eye Disease