atropine low dose (NVK002) / Nevakar, Zhaoke Ophthalmology - LARVOL DELTA

Vyluma Announces Acceptance of Drug Application for NVK002 by China’s National Medical Products Administration (NMPA) (GlobeNewswire) - "Vyluma, Inc...announced today that the National Medical Products Administration (NMPA) of China has accepted the drug application from Zhaoke Ophthalmology Limited...for its lead compound, NVK002 (low-dose atropine 0.01%), as a potential treatment for myopia progression in children...The drug application is based on the first Phase III clinical trial ('Mini-CHAMP') conducted by Zhaoke in China."

China filing • Ophthalmology

CHAMP: Study of NVK-002 in Children With Myopia (clinicaltrials.gov) - P3 | N=670 | Completed | Sponsor: Vyluma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology

Comparative Rebound Effects in Myopia Control: Insights from CHAMP and LAMP Trials of Low-Dose Atropine (AAO 2024) - "0.01% in both trials showed minimal rebound. Conclusion Given the clear efficacy, these data support the preferential use of lower atropine concentrations (0.01%, 0.02%) in managing myopia due to their limited rebound effect after cessation, especially when compared to higher doses like LAMP's 0.05%, emphasizing careful consideration of dose in therapeutic planning."

Ophthalmology • Strabismus

Predicting Long-Term Myopia Control: Insights From the CHAMP Phase 3 Trial of NVK002 0.01% Atropine (AAO 2024) - "Conclusion One-year effect of NVK002 is a good indicator of 3-year outcomes, underscoring its practical value in myopia progression management. Despite individual variability, NVK002 shows a population-level benefit over placebo."

P3 data • Ophthalmology • Strabismus

NVK002 low-dose atropine 0.01% produced clinically meaningful myopia control over 3 years in the CHAMP phase 3 clinical trial for treatment of pediatric myopia progression (ARVO 2024) - "These findings underscore the clinical significance of NVK002 low-dose atropine 0.01% in controlling pediatric myopia, particularly in children with lower baseline myopia. The marked 63% relative improvement in responder rates in the broader mITT population and the even more pronounced 90% improvement in the subset with low baseline myopia reinforce the rationale for early intervention with NVK002 0.01% in the myopic process, rather than delaying until further progression. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P3 data • Ophthalmology

NVK002 low-dose atropine 0.01% maintains myopia control during a fourth year of dosing and discontinuation does not cause rebound myopia progression (ARVO 2024) - "These findings from Stage 2 of the CHAMP phase 3 trial suggest that NVK002 low-dose atropine 0.01% continues to be both effective and safe in treating pediatric myopia progression following four years of nightly dosing. Moreover, after switching to placebo drops for one year following three years of dosing with NVK002 0.01%, there was no meaningful rebound effect. These data support NVK002 0.01% as a potential long-term treatment for pediatric myopia."

Dry Eye Disease • Ophthalmology

The CHAMP phase 3 clinical trial of NVK002 low-dose atropine for treatment of pediatric myopia progression: A time-to-event analysis (ARVO 2024) - "The TTE analysis indicates a clear therapeutic benefit of both concentrations of NVK002 over placebo in controlling myopia progression using clinically meaningful endpoints. This evidence further supports the potential of NVK002 as a treatment for myopia management in the pediatric population, offering a promising avenue to mitigate the long-term ocular complications associated with myopic progression. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand."

Clinical • P3 data • Ophthalmology

The Efficacy of NVK002 in Treating Pediatric Myopia Progression is Maintained Each Year over 36 Months in the CHAMP Phase 3 Trial (AAPOS 2024) - No abstract available

Clinical • P3 data • Ophthalmology • Pediatrics

Does Myopia Control at 12 Months Predict 3-Year Efficacy of NVK002 Atropine 0.01% in the CHAMP Clinical Trial of Low Dose Atropine for Pediatric Myopia (AAPOS 2024) - No abstract available

Clinical • Ophthalmology • Pediatrics

NVK002 Low-Dose Atropine for Treatment of Pediatric Myopia Progression: Analysis of Efficacy by Baseline Subgroups (AAO 2023) - "No treatment-by-subgroup interaction was identified. Conclusion Over 3 years, NVK002 0.01% effectively slowed myopia progression regardless of baseline characteristics."

Clinical • Ophthalmology

Low-Dose Atropine for Treatment of Pediatric Myopia Progression: Analysis of Responders by SER Progression Over 3 Years (AAO 2023) - "Proportion of responders versus placebo was 31.6%/21.3% (<0.50 D, P = .007), 42.8%/29.4% (<0.75 D, P = .001) and 54.8%/43% (<1.00 D, P = .006) at 3 years. Conclusion Over 3 years, NVK002 0.01% meaningfully slowed myopia progression at 0.50 D, 0.75 D and 1.00 D thresholds."

Clinical • Ophthalmology

Vyluma Announces FDA Acceptance of New Drug Application for NVK002, Its Novel Investigational Treatment for Pediatric Myopia (GlobeNewswire) - "Vyluma, Inc...announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead compound, NVK002 (low dose atropine 0.01%) as a potential treatment for myopia in children....A Prescription Drug User Fee Act (PDUFA) goal date of January 31, 2024, has been assigned by FDA....Vyluma’s NDA is supported by positive results from its landmark, three-year, placebo-controlled international Phase III CHAMP (Childhood Atropine for Myopia Progression) clinical study..."

NDA • PDUFA date • Ophthalmology