MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
FDA premarket approval P180035/S031 · decided 2025-10-28
Approval details
- PMA number
- P180035
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
- Generic name
- Daily wear soft contact lens to reduce the progression of myopia
- Applicant
- CooperVision, Inc.
- Date received
- 2025-08-27
- Decision date
- 2025-10-28
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- Approval of protocol changes to enroll approximately 1000 subjects in PAS002 to achieve at least 4000 patient years total (approximately 2000 per study) with an average follow up of 2-3 years per subject. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180035.
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