Macular Degeneration is the leading cause of blindness and vision loss in people over 50 –and with life expectancies well into the 80s, it is estimated that 1 and 3 elderly individuals will have to deal with this degenerative disease. The remedy? Monthly injections (via needle) into the back of the eye, where the disease lives. Not only does this method come with the possibility of an infection, but the costs of this treatment – upwards of thousands per injection – renders it impossible to achieve in third world nations.
Enter Charlesson LLC, which thanks to some SBIR grants from the Department of Health and Human Services (HHS) and supplemental state funding, has developed a patented means to deliver therapeutics right to the retina – without the use of invasive needles.
“One inherent problem with injections is that if a variety of drugs are needed, you can’t use 8 needles at once,” explains Charlesson CEO Dr. Rafal Farjo. “By making these emulsions, you can deliver a customized treatment for each individual within an eye drop, and successfully reach the back of the eye.”
The technology is called Microemulsion Drug Ocular Penetration System (MiDROPS™) and it allows the topical delivery of compounds into the eye in a non-invasive manner. Charlesson spun off eyecro – short for Eye Contract Research Organization – in order to dedicate the necessary personnel and research to this coveted medical breakthrough. It is eyecro’s goal to be able to formulate eye drops for a variety of applications in therapeutics. In the future, eyecro would like to tackle diabetic retinopathy, diabetic eye diseases, inherited and genetic diseases like retinitis pigmentosa, and eventually Glaucoma. Farjo credits the SBIR program with helping the company to take the necessary steps needed to venture out into the new and unknown spinoff territory.
“When we first started getting our grants from HHS, we had to identify industry partners, and we realized two things,” says Farjo. “The quality of the science wasn’t up to par with what we had in our own research lab since the research wasn’t well optimized, and many studies were cost prohibitive. We thought – we can do this better ourselves and offer a higher standard of science, while at a lower cost to enable more academic and startup groups the ability to conduct preclinical studies. So that was the start of eyecro. And we are in the process of spinning off another organization as well.”
Earlier this year, eyecro made public a deal with NeuMedics Inc. to facilitate the development of NM108, a first-in-class small molecule to treat a number of ophthalmic disorders that lead to blindness, including Diabetic Retinopathy. The collaboration grants NeuMedics full access to the eyecro’s MiDROPS formulation platform. eyecro will receive a tiered single-digit royalty on commercialized products for ophthalmologic indications as well as a number of development and regulatory milestones.
As for the new spinoff, Farjo is focused on developing a treatment for diabetic eye disease. The company, called FenoVision, is based on the Fenofibrate therapeutics originally thought to treat heart and kidney problems in diabetic patients caused by elevated lipids. While it didn’t prove to solve those issues, it did show substantial improvement in preventing or reducing severity of Diabetic Retinopathy. Charlesson/eyecro is hoping that this too, may also be delivered via its MiDROPS™ platform in what will be an expedited clinical approach.
It may seem like eyecro is on the fast track to success in an industry that is notoriously slow to market, but Farjo credits part of this to the company’s location in Oklahoma. With Charlesson originating right inside the University of Oklahoma by a faculty professor, it makes sense that the University is still a cornerstone of its success. eyecro has a longstanding partnership with the University of Oklahoma Heath Sciences Center – this allows the company to keep costs low while providing a benefit to the University as well. Another factor has been the company’s relationship with the Oklahoma Center for the Advancement of Science & Technology (OCAST) – which has been instrumental in securing SBIR grants.
“OCAST was absolutely fantastic for us because they enabled us to use these small grants to get to proof of concept data, and those were used to submit a successful SBIR proposal,” adds Farjo. “That early stage funding was critical for us. Beyond that, they really do have a vision to understand and know the new technologies that can attract and retain talent to the state. It is a very collaborative environment here in Oklahoma, and people are team inspired and motivated.”
While preclinical trials for MiDROPS are currently being conducted, Charlesson has high hopes for some of its applications, which will begin human clinical trials in 2017.
Through its Microemulsion Drug Ocular Penetration System (MiDROPS™) – eyecro has developed a custom library of thermodynamically-stable micro emulsions which can replace needles and injections which are normally used to treat degenerative ocular diseases.