July 08, 2008
The US Food and Drug Administration (FDA), Center for Devices and Riadiological Health has informed Vistakon about the positive decision on the premarket notification (called 510(k)) for a new type of Contact Lenses made from narafilcon A.
Within the application, originally submitted by Vistakon back in December of 2007, the description of the new lenses - which includes 1-DAY ACUVUE® TruEye® - reads as following:
The VISTAKON (narafilcon A) Contact Lens Clear and Device Visibility Tinted with UV blocker is available as a spherical lens, multifocal lens, toric lens, and toric-multifocal lens.
- The lenses are made of a silicone hydrogel material containing an internal wetting agent.
- The VISTAKON (narafilcon A) Contact Lens may be tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling
- A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 1% in the UVB range of 280 - 315nm and less than 10% in the UVA range of 316 - 380nm.
- The VISTAKON (narafilcon A) Contact Lens is a hemispherical or hemitoric shell.
- The lens is supplied in a sterile state, packaged in a buffered saline solution with methyl ether cellulose.
- The composition of the lens is 54% narafilcon A and 46% water by weight when hydrated and stored in the buffered saline solution.
So, everything is lining up for a successful product introduction in the US. As previously reported, 1-DAY ACUVUE® TruEye® was unveiled at the British Contact Lens Association conference in Birmingham (May 29). 1-DAY ACUVUE® TruEye® will be available in the UK and Ireland in autumn 2008, with the US following afterward.
Additional information including updates and images are available in the new 1-DAY ACUVUE® TruEye® section.
But is the application also revealing that there might be other narafilcon A based ACUVUE® contact lenses coming?
The 'Indications for Use' section describes various different lens designs:
1-DAY ACUVUE® TruEye® (narafilcon A) Contact Lenses are indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON (narafilcon A) Contact Lenses are indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less.
The VISTAKON (narafilcon A) Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON (narafilcon A) Contact Lens is indicated Toric for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
VISTAKON (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
So what does this mean?
The first indication-for-use paragraph (Spherical) is most likely referring to the new 1-DAY ACUVUE® TruEye® (Note: Intro Date for the US still unknown). But will there be a Multifocal and/or a Toric (for Astigmatism) version as well? And would they be marketed as e.g. 1-DAY ACUVUE® TruEye® for Astigmatism or 1-DAY ACUVUE® TruEye® Multifocal? We don't know yet, but will keep our eyes (and ears) open.
Source: lenses-now.com, FDA (www.fda.gov/cdrh/ Summer Report 2008)