Adjustable Injectable Intraocular Lens

DESCRIPTION (provided by applicant): Using proprietary light adjustable materials technology, Calhoun Vision's mission is to perfect vision in patients undergoing cataract and refractive surgery. The injectable, accommodating light adjustable intraocular lens system proposed to address presbyopia in the cataract patient is comprised of an injectable, gel-filled capsular lens with an adjustable, anterior capsule supported intraocular lens (AC-LAL). The AC-LAL is formulated from Calhoun Vision's proprietary light adjustable silicone material which allows for in situ post-operative refractive correction of pre-existing and induced spherical and astigmatic errors. The capsular gel lens with modulus mimicking the young human lens promotes restoration of natural accommodative ability for cataract patients. The primary goal of this Phase II proposal is to demonstrate the in vivo performance of the proposed adjustable, injectable intraocular lens system in a primate model. This will be accomplished by: (1) Optimization of UV-absorbing gel material from Phase I for mechanical and optical properties, (2) Develop the AC-LAL design based upon proprietary light adjustable materials, (3) Demonstrate the safety of the AC-LAL and gel material through biocompatibility studies, (4) Develop prototype packaging for sterile gel delivery into the eye, (5) Conduct in vitro testing to demonstrate accommodative amplitude, (6) Conduct rabbit studies to evaluate posterior capsule opacification with the proposed lens system, and (7) Demonstrate accommodation amplitude of the optimized adjustable, injectable lens system in a primate model. Presbyopia is a progressive, age-related loss of accommodation affecting 100 percent of the population which is characterized by the noticeable loss of near vision at the age of 40-45 years with complete loss of accommodation by the age of 50. Conventional treatment has been limited to reading glasses, bifocals or contact lenses. Calhoun Vision's proposed adjustable, injectable silicone intraocular lens incorporating our proprietary light adjustable lens (LAL) material technology may provide for the restoration of accommodative power with in situ post-implantation refraction correction to provide the patient with true spectacle independence for both near and distance vision.