Elate Ocular® is a biologic topical eye drop pooled from donor (allogeneic) versus patient (autologous) sourced platelets. These platelets are then enriched in Cambium’s novel manufacturing process. This process includes the removal of fibrinogen (platelet’s clotting agent) from base platelets. This is done because clotting is not needed or of benefit on the cornea in the treatment of dry eye. Elate Ocular® is currently being evaluated in a clinical study involving patients with Graft versus host disease dry eye (ocular or oGvHD). These are patients typically with severe debilitating dry eye as a result of a bone marrow transplant. Cambium chose this patient population not because it would be easy, but because it would be hard. And to demonstrate Elate Ocular®’s safety and efficacy among a most challenging sub-set of dry eye patients. And because, to date, there remains no FDA approved therapy for oGvHD. And because there are no standardized, enriched, allogeneic, cGMP processed and potentially longer term–reimbursed serum drops approved as yet by the FDA. And because Elate Ocular® may also be effective longer term, along with dry eye, in the treatment of other corneal diseases and conditions.
As mentioned, Elate Ocular® is formulated from the novel processing of base human platelets sourced not from patients (common with most serum drops today), but generally healthier younger eligible donors at U.S. blood collection centers. Two significant advantages are derived from this sourcing. One, these centers know and are overwhelmingly focused on blood safety. Numerous safety steps and SOPs are mandated by the FDA involving among other things donor screening, the collecting, the processing, the packaging, the storing and the shipping of all blood products. All this occurs prior to receipt by Cambium of its donor platelets, and in advance of its own safety steps and SOPs. Second, because donors tend to be younger and generally healthier than patient sourced platelets, and because donor platelets are pooled prior to processing—the level and consistency of key platelet components per batch are generally better. The resulting biologic drug is trademarked Aurarix®, Cambium’s novel processed human platelet lysate. Aurarix® is then formulated into Elate Ocular®, the Company’s biologic eye drop for dry eye. Through a strategic partner, Cambium began commercializing worldwide in 2015 Aurarix® in the stem cell growth supplement market under the trademarks UltraGRO Advanced™ and UltraGRO Pure™.
While it must be stressed that Elate Ocular® remains today in development, remains today an investigational biologic unapproved for sale or commercial use and will require eventual FDA review and approval of Cambium’s clinical studies to support the following—a hypothetical comparison Cambium’s Elate Ocular® versus other leading dry eye therapies is provided below: