Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

Pegavision (Toufilcon B) soft contact lenses are silicone hydrogel lenses designed for daily wear vision correction of myopia, hyperopia, and astigmatism in non-diseased eyes. Available in spherical, toric, and multifocal designs, they come in two formats: single-use daily disposable and frequent/planned replacement lenses requiring chemical disinfection.

Both subject and predicate devices are Group V silicone hydrogel lenses manufactured via cast-molding and steam sterilization. Key differences include: subject device water content 50%±2% vs. predicate 48%±2%; oxygen permeability 91 vs. 128 (×10⁻¹¹); light transmittance 95±5% vs. >97%; and refractive index 1.405 vs. 1.400. The subject device includes UV-blocking (Class II) capability. Power ranges are comparable, though the subject offers narrower cylinder power (-0.25D to -3.50D vs. -0.25D to -10.00D).

ISO 18369-3 and 18369-4 for optical and physicochemical properties; ISO 10993 series and ISO 9394 for biocompatibility; ISO 11981 for solution compatibility; ISO 11986 for preservative uptake/release; ISO 11987 for shelf life and sterility; ASTM D1708-13 for mechanical properties; ISO 9394 for 22-day ocular irritation.

Both devices are Group V silicone hydrogels using identical manufacturing processes (cast-molding and steam sterilization) and share the same intended daily-wear indication for vision correction. Clinical trial data (54 subjects, 3 months) demonstrated comparable corrected visual acuity and safety profiles with no serious adverse events in either test or control groups. Non-clinical testing confirmed the subject device meets all established specifications for physical, optical, and chemical properties, and biocompatibility testing showed no cytotoxicity, ocular irritation, or systemic toxicity, establishing functional and safety equivalence to the predicate Biofinity device.