Safety and Efficacy of a Titratable External Shunt

Glaucoma is a diverse group of chronic diseases that causes irreversible damage to the optic nerve and is a leading cause of blindness affecting million people worldwide It is estimated that in people who receive proper treatment for glaucoma still experience loss of vision The only proven method of treating glaucoma is to reduce the pressure in the eye Intraocular Pressure IOP Advanced glaucoma must achieve IOP in the low teens to stop progression Unfortunately less invasive therapies like anti glaucoma drugs and laser surgery do not commonly achieve these low IOPs therefore surgical intervention is required Standard glaucoma surgeries are suboptimal with unpredictable outcomes and high complication rates Camras Vision has created a biocompatible microchannel shunt capable of regulating IOP Our preliminary data demonstrate that the prototype can be used to set in vitro pressure based on the number and length of microchannels within the outlet tube The key to the Camras Shunt s success is its design to drain aqueous humor externally thereby avoiding failure due to scarring within the drainage site associated with all other glaucoma surgeries In this Fast Track application we will create a new generation shunt the Titratable Camras Shunt tCS to enable precise control of IOP In Phase I we will construct a tCS prototype consisting of two outlet tubes initially sealed with sutures each containing a single microchannel that allows for noninvasive manipulation postoperatively Opening and closing of individual tubes controls and adjusts the target IOP range Additionally the tubes can be trimmed in mm increments to fine tune the IOP postoperatively In vitro fluid dynamic testing Aim will be used to assess the ability to set pressure ranges to mmHg with one open channel and mmHg with two open channels and to use tube trimming to reduce resistance with each cut of the outlet tube The feasibility of precisely controlling IOP in vivo Aim will be assessed in cynomolgus monkeys which exhibit similar ocular fluid dynamics as humans over months in partnership with Dr Carol Toris University of Nebraska Medical Center Success and justification for progression to Phase II will be indicated by the ability to set in vivo IOPs to mmHg and mmHg maintain IOP lowering in a month follow up period IOP does not increase more than mmHg reduce IOP by with tube trimming with no evidence of adverse effects to the monkeys In Phase II we will optimize scale up manufacturing in partnership with Sil Pro Medical Manufacturing Solutions The manufactured devices will be tested after sterilization by radiation or ethylene oxide based on FDA guidelines for Aqueous Shunts k Submissions which will first include flow stability uniformity and mechanical testing at Camras facilities Aim Biocompatibility toxicity testing to evaluate safety Aim which includes systemic toxicity genotoxicity chemical testing and month rabbit ocular biocompatibility assessments will be conducted at NAMSA a GLP good laboratory practice approved CRO with extensive ophthalmic experience Success will be indicated if the final form tCS meets or exceeds guidelines set forth by the FDA for Aqueous Shunts to enable Camras Vision to submit a k application Once commercialized we anticipate that the tCS will make glaucoma surgery as accessible as cataract surgery which is known for its elegant surgery effectiveness and minimal complications Moreover the proposed shunt should enable ophthalmologists to target IOP with a quick and simple procedures tube opening and trimming that can be maintained via routine follow up outpatient visits Glaucoma is a leading cause of blindness worldwide and is treated by reducing eye pressure intraocular pressure IOP Current glaucoma treatments include drugs laser therapy and or surgical intervention Although drugs are non invasive they are associated with poor patient compliance and in many cases drugs do not sufficiently lower IOP to stop progression Standard glaucoma surgeries are lengthy and traumatic with unpredictable outcomes and complication rates of There has not been a major improvement in both safety and efficacy of glaucoma surgeries for the last years Camras Vision has developed a prototype shunt which can set and adjust pressure and circumvents the major source of complications present with standard glaucoma surgeries This shunt provides ophthalmologists with the first tool that can predictable control IOP to stop the progression of glaucoma