Adjustable Phakic Intraocular Lens

DESCRIPTION (provided by applicant): Refractive surgery is the most rapidly evolving discipline in ophthalmology today, with 1.2 million procedures performed in 2002. The emergence of phakic intraocular lens (PIOL) technology expands the capabilities of refractive surgery to address higher level of myopic and hyperopic corrections than were previously possible. Despite careful preoperative measurements and calculations of required lens power, errors in the effective implanted lens power, and thus the degree of refractive correction, are similar to errors seen in cataract IOL patients. In addition to imprecise IOL power determinations, uncorrected visual acuity is often limited by pre-existing or induced astigmatism, making it necessary for the PIOL patient to continue with some form of spectacle correction or undergo an additional refractive surgical procedure to become spectacle-free. The objective of this program is to develop a light adjustable acrylic phakic intraocular lens for use in refractive surgery. Using the Company's proprietary technology, any residual spherical or cylindrical refractive errors can be corrected post-operatively in a simple, non-invasive procedure to insure the phakic IOL patient achieves freedom from the need for spectacle correction. Upon successful completion of this project, the Company will be able to commercialize a PIOL for hyperopia (+3 D to 15 D) and myopia (-3 to -20 D), including astigmatism correction of up to 3.0 D. In Phase II, we propose to further study the selected material to optimize the soft acrylic LAL formulation, develop the irradiation conditions to produce predictable myopic, hyperopic and astigmatic changes in refractive power, establish the biological safety of the material through toxicity, animal implant and stability studies, and to evaluate phakic lens designs for feasibility testing purposes. Phase III of the project will include US clinical studies, leading to PMA approval and commercial sales.