QLS-101 is our lead program based upon research from the laboratory of Professor Michael Fautsch at Mayo Clinic. QLS-101 is a novel, ATP-sensitive potassium (KATP) channel modulator, that lowers Intraocular Pressure (IOP) by causing vasodilation of vessels distal to the Trabecular Meshwork, thereby reducing distal outflow resistance and lowering Episcleral Venous Pressure (EVP).
Though multiple mechanisms of action exist to lower IOP, these agents all target 3 of the 4 components of IOP as described by the Goldmann equation for IOP: Aqueous Humor Inflow, Uveoscleral Outflow, or Conventional Outflow Facility. There are currently no approved drugs that solely and significantly lower EVP leaving a major gap in the potential of IOP-lowering therapies since EVP can be a very large contributor to overall IOP.
As a vasodilatory agent, QLS-101 is able to improve flow through vessels distal to the Trabecular Meshwork and significantly lower EVP and improve overall distal outflow. QLS-101 has shown efficacy in lowering IOP across multiple preclinical animal species, including mice, rabbits, dogs, and non-human primates, as well as in human eye explants, and has to date been demonstrated to be well-tolerated with no observed hyperemia.
By uniquely targeting EVP and distal outflow, QLS-101 enables the treatment of diseases for which there are currently inadequate therapies: namely, those diseases of pathologic EVP or where EVP currently sets the floor for maximal therapy despite the use of multiple agents since no approved drugs currently lower EVP primarily.
QLS-101 is currently in preclinical, IND-enabling studies in preparation for entry into human clinical studies.
Sturge-Weber Syndrome (SWS) is a Pediatric Rare Disease signified by a facial port wine stain birthmark. Patients with SWS can often suffer from severe, intractable glaucoma in the eye on the same side as their birthmark. Currently, therapies are limited and only modestly effective since SWS-related IOP elevation is caused by elevated EVP, for which no therapies are currently targeted. By lowering EVP, QLS-101 may be uniquely well-suited to addressing this disease and improving the lives of SWS sufferers.
Normal Tension Glaucoma
Treatment guidelines for patients suffering from Normal Tension Glaucoma (NTG) suggest lowering IOP as far as possible pharmacologically. However, it is well known that the lowest one can lower IOP is to the floor set by EVP since no therapeutic agents can currently lower EVP. By lowering EVP, QLS-101 could present a wholly new paradigm in the treatment of NTG, which can affect up to 40% of glaucoma patients in the US and strikingly, up to 90% of glaucoma patients in East Asia.
Additive Use with MIGS Devices
Minimally (micro) Invasive Surgery (MIGS) devices are a rapidly growing segment of the glaucoma therapy market. MIGS devices serve to obviate certain outflow pathways of the eye to alleviate elevated IOP. Certain devices, such as those that bypass the Trabecular Meshwork and shunt aqueous humor into the distal outflow vessels and Episcopal Veins, could be ideally suited to the combined use of QLS-101 which would allow the further lowering of IOP by the lowering of EVP which currently available pharmacotherapies are unable to provide.
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