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Clinical Trial News

BOTOX® Cosmetic Receives FDA Approval for Platysma Bands

  • BOTOX® Cosmetic (onabotulinumtoxinA) gains FDA approval for temporarily improving the appearance of moderate to severe platysma bands in adults.
  • This approval expands BOTOX® Cosmetic's indications, making it the first and only product approved for forehead lines, frown lines, crow's feet, and platysma bands.
  • Phase III trials showed statistically significant improvement in platysma band appearance with BOTOX® Cosmetic compared to placebo (p<0.0001), based on investigator and subject assessments.
  • The treatment involves injecting BOTOX® Cosmetic along the jawline and vertical bands of the neck, reducing muscle activity and improving jawline definition.

A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

NCT04994535CompletedPhase 3
AbbVie
Posted 8/10/2021

A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence

NCT04949399CompletedPhase 3
AbbVie
Posted 7/8/2021

Real-World Persistence with Ocrelizumab in Multiple Sclerosis Patients

A systematic literature review highlights the real-world persistence and discontinuation rates of ocrelizumab treatment in patients with relapsing remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS), showing low discontinuation rates and high persistence, consistent with clinical trial outcomes.

MIT Develops Ultrasound Bra for At-Home Breast Cancer Detection

  • MIT researchers have developed a novel ultrasound bra that allows women to monitor their breast health at home, potentially improving early detection of breast cancer.
  • The wearable technology utilizes a 3D-printed patch with a tiny tracker that captures real-time ultrasound images from multiple angles, suitable for all breast types.
  • Clinical trials are underway, with hopes for FDA approval within five years, aiming to provide a more accessible and frequent screening method, especially for high-risk individuals and those in lower-income countries.
  • The device could significantly improve survival rates by detecting cancer earlier, addressing the concerning statistic that half of high-risk women develop breast cancer between annual mammograms.

Boston Scientific's Farapulse System Gains FDA Nod for Enhanced Cardiac Mapping

  • Boston Scientific received FDA approval for the Farawave Nav Ablation Catheter, enhancing cardiac mapping and pulsed field ablation (PFA) for paroxysmal atrial fibrillation (AF).
  • The new Faraview software gained FDA 510(k) clearance, offering visualization for cardiac ablation procedures using the Farapulse PFA system.
  • The integrated system provides physicians with a dynamic view of catheter placement and pulsed field application, potentially improving workflow and treatment efficacy.
  • These technologies are exclusively compatible with Boston Scientific's cardiac mapping technology, offering a comprehensive solution for PFA procedures.

Angiopoietin-2 Shows Promise in Treating Cardiovascular Complications of Progeria

  • Researchers have identified Angiopoietin-2 (Ang2) as a key protein linked to cardiovascular health in progeria models, potentially leading to new treatments.
  • The study found that Ang2 can "rescue" endothelial cells, improving blood vessel formation and restoring nitric oxide levels in individuals with progeria.
  • Ang2 treatment may improve endothelial cell signaling, suggesting it could be a potential therapy for vascular dysfunctions associated with HGPS.
  • Further studies are planned to explore different methods of administering Ang2 to animal models, bringing researchers closer to a cure for progeria.

Tiziana Life Sciences' Foralumab Shows Promise in Neurodegenerative and Autoimmune Disease Trials

  • Tiziana Life Sciences reports positive interim results for Foralumab in treating neurodegenerative and autoimmune diseases.
  • A Phase 2 study of Foralumab is currently underway, with the FDA granting Fast Track designation.
  • Foralumab demonstrates the potential to be a more effective and less harmful treatment option for multiple sclerosis.
  • These advancements underscore Tiziana's dedication to developing innovative therapies for significant patient care improvements.

EP-104IAR Shows Promise for Knee Osteoarthritis Pain Relief in Phase 2 Trial

  • Phase 2 trial data indicates EP-104IAR is safe and effective in reducing knee osteoarthritis (OA) pain for up to 14 weeks.
  • The SPRINGBOARD trial demonstrated a statistically significant improvement in WOMAC pain scores with EP-104IAR compared to the vehicle control group.
  • Treatment-emergent adverse events were similar between the EP-104IAR and control groups, with minimal effects on glucose and cortisol levels.
  • EP-104IAR's advanced formulation offers sustained pain relief and an improved safety profile, potentially advancing the standard of care for knee OA.

Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee

NCT04120402CompletedPhase 2
Eupraxia Pharmaceuticals Inc.
Posted 9/10/2021

Vabysmo Shows Vision Improvement in Underrepresented DME Populations in ELEVATUM Study

  • Roche's Vabysmo significantly improved vision in underrepresented racial and ethnic groups with diabetic macular edema (DME), as shown in the ELEVATUM study.
  • Participants experienced an average gain of 12.3 letters on eye charts after one year, with Hispanic/Latino individuals showing a 14.1-letter improvement.
  • The study adjusted HbA1c eligibility criteria to ensure inclusivity, reflecting real-world diabetes management in diverse populations.
  • Vabysmo was well-tolerated, reinforcing its potential as an effective first-line treatment for DME across various racial and ethnic backgrounds.

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

NCT04432831CompletedPhase 3
Hoffmann-La Roche
Posted 8/5/2020

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

NCT06176352Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 3/6/2024

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

NCT04777201CompletedPhase 3
Hoffmann-La Roche
Posted 4/19/2021

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

NCT05224102Active, Not RecruitingPhase 4
Genentech, Inc.
Posted 2/28/2022

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

NCT05476926Recruiting
Hoffmann-La Roche
Posted 11/21/2022

Neoadjuvant Immunotherapy Shows Promise in Improving Outcomes for Liver Cancer Patients

  • Neoadjuvant immunotherapy can shrink locally advanced liver tumors, potentially making them eligible for surgical removal.
  • Administering immunotherapy before surgery allows the immune system to mount a broader response against cancer antigens, reducing micrometastases.
  • A study at Johns Hopkins found that neoadjuvant immune checkpoint inhibitors led to successful resections in patients who initially were ineligible for surgery.
  • While recurrence-free survival was comparable, the findings suggest current criteria for curative therapy may be too narrow, warranting further prospective trials.

FDA Issues Draft Guidance on Patient-Reported Outcomes in Cancer Clinical Trials

  • The FDA has released draft guidance on using patient-reported outcome (PRO) instruments in cancer clinical trials, aiming to capture the patient's perspective on treatment benefits.
  • The guidance addresses the selection, development, and use of PRO measures to support claims in cancer drug development, emphasizing the importance of well-defined concepts of interest.
  • Recommendations include ensuring PRO instruments are reliable, valid, and able to detect changes relevant to patients, as well as minimizing missing data.
  • The FDA's guidance seeks to standardize the use of PROs, facilitating more meaningful and interpretable data for regulatory decision-making and ultimately improving patient care.

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