EyeGate Pharma is taking two technology platforms quickly through to commercialization, CEO Stephen From said. The first is a hyaluronic acid (HA) the company is cross-linking. The technology is moving through a 510(k) De Novo pathway with the first human clinical trial completed in patients who had undergone photorefractive keratectomy (PRK), with a filing expected at the end of 2018. “We see this as a versatile product that can be used in several ocular surface indications from wounds to epitheliopathies,” From commented. More studies should start early next year; cross-linking prevents the degradation commonly associated with HA.
In their platform, EyeGate can get HA at 8 times the concentration of other products but without the blurring issues. “We’ve found this formulation is able to stay on the surface for up to two hours,” he said. In the PRK patients, at day 3, EyeGate’s product was able to close 83.3% of wounds (compared with 64.3% with the addition of a bandage contact lens, or 53.8% with standard of care). The company is in discussions with the FDA about initiating an SPK study. Second, EyeGate is concentrating on direct delivery of medications through iontopheresis.
Its EGP-437 (corticosteroid) is in a Phase III study for anterior uveitis with data expected in the first half of 2018. Bausch + Lomb has licensed the platform for both uveitis and inflammation associated with cataract surgery. In the clinic, the technology can be used noninvasively to treat macular edema, From said. The noninvasive method propels an active charged compound into the eye; more than 2,400 treatments have been performed in an office setting. Each treatment takes about one to three minutes. EyeGate also just completed enrollment in its Phase I/II cataract study. Finally, the company is taking its technology and embedding it in a contact lens. The first indication will use dexamethasone for macular edema; proof-of-concept animal data are expected my mid-2018.