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Eyevensys a private, clinical-stage biotechnology company developing non-viral gene therapies for ophthalmic diseases, this week presented results from part 1 of its phase I/II study for non-infectious uveitis (NIU) at the Ophthalmology Innovation Summit’s (OIS) 11th Annual OIS@AAO conference on October 10, 2019 in San Francisco. Dr. 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 six 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 U.S. Food and Drug Administration in August 2019. This IND allows Eyevensys to further validate the technology in a phase II 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.
Dr. Buggage said, “We are extremely proud to reach this stage of development with our lead clinical candidate based on the Eyevensys technology. 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.”
Dr. Patricia Zilliox, Chief Executive Officer, said, “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. 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.”
Eyevensys is a private clinical stage biotechnology company developing its innovative technology to enable the sustained intraocular production of therapeutic proteins to treat a broad range of ophthalmic diseases.
The Eyevensys technology, developed by Dr. Francine Behar-Cohen in Paris, uses electroporation to deliver improved proprietary DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye. This approach facilitates the sustained intra-ocular production of therapeutic proteins.
Eyevensys' lead product EYS606 is a potential new treatment for patients with chronic non-infectious uveitis (NIU). EYS606 combines Eyevensys' proprietary Electrotransfection System with plasmids encoding for the production of a potent fusion protein which neutralizes the activity of TNFα, a cytokine that has been shown to play a pivotal role in mediating intraocular inflammation in NIU. EYS606 is currently in a phase I/II clinical trial in the EU and has been granted an Orphan drug designation by the European Medicines Agency (EMA) for the treatment of NIU. The therapeutic potential of EYS606 in patients with active, chronic NIU will be further investigated in Part 2 of the ongoing EYS606-CT1 study in the EU and in the Phase 2 EYS606-CT2 (Electro) Study that will be launched in the US in early 2020.
Eyevensys was founded in 2008. It is headquartered in Paris, France, incorporated in the U.S., and is funded by Boehringer Ingelheim Venture Fund, BPIFrance, CapDecisif, Inserm Transfert, Pontifax and GHS.
For more information about Eyevensys please visit www.eyevensys.com.
Marion Janic, RooneyPartners
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