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 affectingmillion people worldwideIt is estimated thatinpeople who receivepropertreatment for glaucoma still experience loss of visionThe only proven method of treating glaucoma is to reduce the pressure in the eyeIntraocular PressureIOPAdvanced glaucoma must achieve IOP in the low teens to stop progressionUnfortunatelyless invasive therapies like anti glaucoma drugs and laser surgery do not commonly achieve these low IOPsthereforesurgical intervention is requiredStandard glaucoma surgeries are suboptimal with unpredictable outcomes and high complication ratesCamras Vision has created a biocompatible microchannel shunt capable of regulating IOPOur 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 tubeThe key to the Camras Shunt s success is its design to drain aqueous humor externallytherebyavoiding failure due to scarring within the drainage site associated with all other glaucoma surgeriesIn this Fast Track applicationwe will create a new generation shuntthe Titratable Camras ShunttCSto enable precise control of IOPIn Phase Iwe will construct a tCS prototype consisting of two outlet tubesinitially sealed with sutureseach containing a single microchannelthat allows for noninvasive manipulation postoperativelyOpening and closing of individual tubes controls and adjusts the target IOP rangeAdditionallythe tubes can be trimmed inmm increments to fine tune the IOP postoperativelyIn vitro fluid dynamic testingAimwill be used to assess the ability to set pressure ranges tommHg with one open channel andmmHg with two open channelsand to use tube trimming to reduce resistancewith each cut of the outlet tubeThe feasibility of precisely controlling IOP in vivoAimwill be assessed in cynomolgus monkeyswhich exhibit similar ocular fluid dynamics as humansovermonths in partnership with DrCarol TorisUniversity of Nebraska Medical CenterSuccess and justification for progression to Phase II will be indicated by the ability to set in vivo IOPs tommHg andmmHgmaintain IOP lowering in amonth follow up periodIOP does not increase more thanmmHgreduce IOP bywith tube trimming with no evidence of adverse effects to the monkeysIn Phase IIwe will optimize scale up manufacturing in partnership with Sil Pro Medical Manufacturing SolutionsThe manufactured devices will be tested after sterilizationby radiation or ethylene oxidebased on FDA guidelines forAqueous ShuntskSubmissionswhich will first include flowstabilityuniformityand mechanical testing at Camras facilitiesAimBiocompatibility toxicity testing to evaluate safetyAimwhich includes systemic toxicitygenotoxicitychemical testingandmonth rabbit ocular biocompatibility assessmentswill be conducted at NAMSAa GLPgood laboratory practiceapproved CRO with extensive ophthalmic experienceSuccess 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 akapplicationOnce commercializedwe anticipate that the tCS will make glaucoma surgery as accessible as cataract surgerywhich is known for its elegant surgeryeffectivenessand minimal complicationsMoreoverthe proposed shunt should enable ophthalmologists to target IOP with a quick and simple procedurestube opening and trimmingthat can be maintained via routine follow up outpatient visits