dm+d

Unassigned

New Medicines

Chronic non-infectious uveitis

Information

New molecular entity
Eyevensys
Eyevensys

Development and Regulatory status

Phase II Clinical Trials
None
Phase II Clinical Trials

Category

An engineered plasmid encodes a recombinant fusion protein consisting of the extracellular domain of the human tumour necrosis factor-alpha (TNF-α) p55 receptor linked to the human IgG1 Fc which neutralise TNF-α. The company utilises its EyeCET platform, that uses Electro-Transfection Injection System (ETIS), for the accurate injection of a high expression plasmid into the ciliary muscle to induce transfection of the plasmid into the ciliary muscle cells.
Anterior uveitis is the most common form in the UK. The prevalence of uveitis is variously given as 25-50 per 100,000 persons, with the mean onset at 30.7 years of age. Most people who develop uveitis are aged 20-50 years. Roughly 5% to 10% of these cases occur in children under the age of 16. Systemic corticosteroids are the mainstay of systemic treatment for patients with chronic uveitis: the usual indication for treatment is presence of macular oedema and visual acuity less than 6/12 [1].
Chronic non-infectious uveitis
Intraocular

Trial or other data

Oct 21Eyevensys completes the PII ELECTRO trial that evaluated the safety and efficacy of two EYS 606 treatment regimens in patients with active CNIU (EYS606-CT2; NCT04207983). The randomised open label trial was initiated in February 2020 and enrolled three patients in the US [3].
Jun 21PI/II trial (NCT03308045) completes [2].
Oct 19Company releases preliminary efficacy results from the PI/II trial (NCT03308045). EYS 606 showed clinical improvements lasting for six months after single administration in three of nine patients. In lowest dose cohort, one patient experienced a >10 ETDRS letter improvement in best corrected visual acuity (BCVA) from baseline. Also 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 [3].
Apr 17PI/II trial to evaluate the safety and tolerability of EYS 606 when the plasmid component of EYS606 is administered using EyeCET technology by electro-transfer into the ciliary muscle of patients with non-infectious posterior, intermediate or pan uveitis starts (EYS606-CT1; NCT03308045). The open-label, multicentre dose escalation trial will enrol 15 adults in France and the UK (at Bristol Eye Hospital and Moorfields Eye Hospital). Cohort 1 will receive pEYS606 lower dose; Cohort 2 intermediate dose; Cohort 3 higher dose; and an Extension Cohort the maximum tolerated dose [2].