Cataract is a condition where vision is lost because the human ocular lens becomes opaque. To address this second problem, the cataractous lens material is removed from its capsular sac and a fixed intraocular lens (IOL) inserted which corrects only distance vision.
DV Gel has been designed to replace both the rigid, older in presbyopia and/or the cataractous lens material with a soft pliable gel, thereby restoring the ability to read unaided. The old (presbyopic) or opaque (cataractous) natural lens material is removed through a small aperture in the lens capsular sac and the DV Gel injected directly into the sac through the same aperture.The old (presbyopic) or opaque (cataractous) natural lens material is removed through a small aperture in the lens capsular sac and the DV Gel injected directly into the sac through the same aperture. When near vision is needed, a muscle in the eye called the ciliary muscle contracts and it is intended that the lens capsular sac filled with the soft cohesive Gel will automatically change shape, increasing the lens power thus enabling reading vision – just like the young natural lens. Conversely when a person looks in the distance, the ciliary muscle controlling the tension on the lens capsule would relax, reducing the lens power and automatically allowing clear distance. The DV Gel is intended to mimic the capabilities of a young eye by giving clear vision at all distances automatically.
Accommodation
Younger people have the ability to rapidly and imperceptibly change the focus of the eyes from far to very close distances. This process, called accommodation, is mediated by the ocular (crystalline) lens and is triggered (when a near object first starts becoming blurred) by visual feedback from the eye and the brain to a (ciliary) muscle inside the anterior eye which constricts, relaxing the tension on the (zonular) fibers stretching the ocular lens capsule, allowing the lens itself to adopt a more curved shape. This almost instantaneous steepening in shape in young people increases the lens optical power, clearing the near image automatically. Subsequent relaxation of the fibers allows clear distance vision to return equally as quickly in young people.
Presbyopia
In presbyopia, a condition that affects every person over the age of 40 to 55 years of age (depending on climate and a number of other factors), the ocular lens material becomes more rigid, losing its ability to change its shape sufficiently for the patient to be able to focus clearly at close distances. There are well over a billion people with functional (significant) presbyopia globally.
DV Gel and Presbyopia
DV Gel offers a novel solution to presbyopia, being designed to mimic the natural performance of a young accommodating ocular lens by replacing the more rigid, older, ocular lens material with a soft and pliable polymer. The product is intended to be injected directly into the sac through the same aperture from which the rigid, older, natural ocular lens contents have been removed. The soft, pliable, but cross linked DV Gel, is intended to fill the sac and when the patient tries to read or see at close distances, the lens shape can automatically change power and focus on a near object.
The (intended) effect created in an older person is that of a young eye with the ability to see clearly at all focal distances and without the glare, contrast loss, halos or ghosting, which can be problems with rigid multifocal intraocular lenses (IOLs). The procedures is intended to be fully reversible. Should it be necessary, the Gel could be removed through the same aperture as used in the filling procedure.
Cataract
Cataract is a loss of transparency of the ocular lens varying from slight to complete opacity which obstructs the light from an image reaching the retina. Dense cataracts cause blindness. Cataracts result from a variety of causes including aging, trauma, diabetes etc. Age-related lenticular (cataractous) changes have been reported in more that 50% of the population over 52 years of age in the United States. At least 18 million people are blind from cataract globally.
Cataract and Intraocular Lenses (IOLs)
When the human ocular lens is removed during cataract surgery, that lens power must be replaced in the eye otherwise the eye remains virtually blind (<20/400). The most commonly used procedure is to insert a fixed, single focus intraocular lens into the eye which restores refractive power for one visual distance only. More recently, multifocal lenses, designed to provide two foci and lenses that have two or more elements designed to physically shift position, have been introduced to try to provide both distance and reading vision. These attempts to correct distance and near vision are all a compromise, generally giving only small levels of near vision help and in the multifocal fixed lenses they can have additional problems of decreasing contrast vision, ‘glare’ and ‘flare’.
Cataract and DV Gel
Dynamic Vision (DV) Gel is designed to replace the hardened ocular lens in older people and those with cataracts in order to restore the eye’s ability to focus at all distances, including close vision. The inefficient lens is surgically removed and the DV Gel is injected directly into the sac through the aperture from which the original lens was removed.
The DV Gel is expected, and has been measured, in in-vitro human and animal studies, to provide more accommodation (5-10 dioptres) than is possible with any current pseudo-accommodating IOL (less than 2 dioptres).
In vitro human and animal studies have establish the feasibility of the DV Gel method of restoring accommodation. Longer term biocompatibility testing on the DV Gel material is in progress. New and modified equipment has also been developed for DV Gel surgery. Key aspects of the DV Gel technology have been patented or are patent pending.
DV Gel Patents
Vision CRC/CRCERT and their collaborators have been researching and developing Corneal Onlay and DV-Gel for the past 15 years.
Through its licensing arrangement with Viscorp, Adventus maintains strong intellectual property protection through the 20 issued patents, three pending and two applications for patents protecting these two products in the United States. Certain of these patents are also protected in most of the world.
In return for issuance of Adventus common stock, Adventus has obtained, from Viscorp, an exclusive worldwide license to market and sell both products whilst the research collaborators have retained the right to conduct further research using the licensed intellectual property and have retained the right to use the intellectual property for other applications including the development of an inlay product. Adventus has agreed to license exclusively any intellectual property it develops to Viscorp and research collaborators, royalty free and irrevocable, for other applications. Adventus has the right to negotiate a license to use the intellectual property for the inlay application. All further costs incurred in the continued development and improvement of either Onlay or DV Gel will be born by Adventus.
DV-Gel