Eyevensys this week presented results from part 1 of its phase 1/2 study for noninfectious uveitis (NIU) at the Ophthalmology Innovation Summit’s (OIS) 11th Annual OIS@AAO conference on October 10, 2019 in San Francisco. Ronald R. Buggage, MD, Chief Medical Officer of Eyevensys, discussed the novel technology during the Gene & Cell Therapy Spotlight session.
The company’s technology is a non-viral gene therapy ocular drug delivery platform that uses a two-part Electrotransfection System, including a proprietary Ocular Device and Electrical Pulse Generator, that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle. This turns the eye into a biofactory, allowing the ciliary muscle to produce the therapeutic protein. The secreted protein reaches the back of the eye, including the retina and choroid.
Eyevensys has successfully completed Part 1 of a clinical safety study of its lead product EYS606, a non-viral vector encoding an anti-TNFα protein. Tumor necrosis factor alpha (TNFα) is a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation. The trial enrolled nine patients (three patients per cohort) with late-stage, NIU in France and the U.K. The study revealed no serious adverse events related to the Eyevensys technology and the overall early safety profile was similar to that of other intraocularly administered ophthalmic treatments.
Despite their advanced disease stage at enrollment three of the 9 patients treated with EYS606 showed clinical improvements lasting for 6 months after one administration of the treatment. The first patient treated in the lowest dose cohort experienced a >10 ETDRS letter improvement in best corrected visual acuity while two patients treated in the highest dose cohort showed a significant reduction of macular edema via optical coherence tomography (OCT) associated with at least +12 ETDRS letters increase in BCVA from baseline.
An investigational new drug (IND) application was filed in July 2019 and subsequently cleared with the FDA in August 2019. This IND allows Eyevensys to further validate the technology in a phase 2 clinical study targeting patients with active chronic NIU. In parallel, Eyevensys is also advancing preclinical programs using different proteins for other ophthalmic diseases, including retinitis pigmentosa, dry AMD, glaucoma, macular edema associated with wet-AMD, DME, and CRVO.
“We are extremely proud to reach this stage of development with our lead clinical candidate based on the Eyevensys technology,” Dr. Buggage said in a company news release. “The potential to express a diversity of therapeutic proteins at effective intraocular concentrations sustained for over 6 months with our minimally invasive, non-viral gene therapy drug delivery platform will revolutionize the way we treat ocular diseases while reducing the burden of treatment for both patients and ophthalmologists.”
“We’re pleased to have an opportunity to share these initial findings from our lead study with our peers and offer a glimpse into ongoing development at Eyevensys to date,” Dr. Patricia Zilliox, Chief Executive Officer, said in the news release. “With these results, we can continue to move forward with our strategy to introduce our proprietary technology, the Electrotransfection System, into the treatment paradigm to improve long-term therapeutic outcomes.”