Eyeworld

EW CORNEA 66 May 2017 by Liz Hillman EyeWorld Staff Writer everything from cases of dry eye to chemical burn injuries to abrasions and even ocular surface disease due to contact lens wear. "I think the other aspect that's really exciting is it's hyaluronic acid—this is a polymer that's known to ophthal- mologists, we're familiar with it. There is so much data on thousands of animals where this polymer has demonstrated excellent safety and efficacy not just in research models but in real animals. These animals have come in with non-healing ul- cers or severe dry eye which haven't responded to a routine standard of care. This topical crosslinked HA has significantly benefitted the patient, in those cases dogs and cats. The wealth of data speaks to a high like- lihood of success." EyeGate's other technology in the pipeline—EGP-437 delivered via an iontophoresis system—released clinical trial data within the last few months as well. In early Decem- ber 2016, it announced data from the third stage of its phase 1B/2A clinical trial of technology that uses a charge to deliver a drug, such as dexamethasone, into the ocular tissue. This trial specifically involved cataract surgery patients where EGP- 437 was used as an anti-inflammato- ry and pain-relieving therapy. Thirty patients were divided into cohorts to receive iontophoretic doses of EGP-437 at either 4.5 mA- min or 14.0 mA-min or a placebo at 14.0 mA-min. Doses were ad- ministered preop and on day 1 and day 4 postop in the 14.0 mA-min group, and on day zero immediately postop, day 1, and day 4 for the 4.5 mA-min. Thirty percent of patients on day 14 and 80% on day 28 in the 4.5 mA-min group saw a complete resolution of anterior chamber cell (ACC) counts or an ACC count of zero. Eighty percent of patients in the placebo group, conversely, had to be rescued before day 14. From a pain standpoint, 70 to 90% of patients who received EGP-437 at 4.5 or 14.0 mA-min respectively reported a pain score of zero as early as day 1 postop. On the flip side, only 10% of those in the you can't put a contact lens on or a non-healing ulcer or neurotrophic ulcers… I think it will hopefully be another tool in our dry eye treat- ment box that can help with these patients," Dr. Wolsey said. This compound is what had Barbara Wirostko, MD, chief med- ical officer of EyeGate and adjunct associate professor, University of Utah School of Medicine, Salt Lake City, founding Jade Therapeutics (ac- quired by EyeGate in March 2016) in September 2011. At that time, the University of Utah invented a topical HA polymer that was being developed and manufactured by SentrX, SLC, Utah, and sold by Bay- er Animal Health to the veterinary market to heal the cornea. Prior to acquisition by EyeGate, Dr. Wirost- ko and Jade co-founder MaryJane Rafii, PhD, originally planned to add other components—small mole- cules, proteins, and growth factors— to the novel HA polymer. "That's where we took a step back … and said 'Wow, this poly- mer in and of itself has been shown to heal corneas in animals,'" Dr. Wirostko said. "What is really unique is this HA polymer. Un- like other topical eye drops, even lubricants, if you put a drug in the commonly recognized vehicles, the vehicle will stay on the eye for several seconds to minutes, while this HA polymer stays on the eye for upwards of 90 minutes. So now, whatever you add to this HA poly- mer, it can stay on the cornea and ocular surface for up to 90 minutes." Crosslinking the polymer con- trols its viscosity, meaning it can take various forms. "You can use it as an eye drop. You can make it into a film. It could be drug delivery. It could be a topi- cal bandage. It could be a bandage film. It has so much versatility," Dr. Wirostko said. "As a clinician, the whole reason I went down this path of research was due to the unmet need for treatments that can help accel- erate healing of the cornea," Dr. Wirostko explained later, adding that she believes the HA polymer could speed re-epithelization in alone saw complete wound closure by day 3, compared to 53.8% of pa- tients receiving BCL standard-of-care therapy. The average wound surface area just 24 hours after surgery was 18.5 mm 2 in the OBG alone group, compared to 39.5 mm 2 in the BCL standard-of-care group, which the company noted is a 53.3% improve- ment. Darcy Wolsey, MD, adjunct assistant professor, University of Utah, and private practice, The Eye Institute of Utah, Salt Lake City, was involved in the pilot study and said while there wasn't much of a dif- ference in the rate of healing in the group that received OBG and BCL, personally, she felt those eyes looked the best. "Obviously, no bandage lens after PRK is quite miserable in the first 24 to 48 hours, so it's certainly not something most of us would jump to as treatment, but it shows that OBG alone can heal. So if you have patients with an abrasion that EyeGate has completed studies on two of its product platforms T he results from the first human trials of an ocular bandage gel made from a compound that's already well-known in dermatology and in veterinary medicine for rapid corneal healing were announced in late January. Ocular Bandage Gel (OBG, EyeGate Pharmaceuticals, Waltham, Massachusetts), which is based on hyaluronic acid (HA) that has been modified into a thiolated carboxymethyl HA, which in and of itself has healing properties, was compared to OBG with a bandage contact lens, and artificial tears with a bandage contact lens (BCL) (the standard of care group) in 39 patients who had bilateral PRK. According to EyeGate, 83.3% of patients who received the OBG Company looking at novel approaches to corneal healing and drug delivery Eyegate II System: EyeGate is researching drug delivery with an iontophoresis system that uses a low electrical charger to deliver therapeutic agents into the eye. Source: EyeGate

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