Objective Acuity ("OAL") today announced the completion of a pilot study using 
OAL's threshold visual acuity test for young children diagnosed with 
late-infantile neuronal ceroid lipofuscinosis Type 2 (CLN2 disease), a form of 
Batten disease.

A prominent feature of CLN2 disease is vision loss, which typically develops 
when cognitive, motor and language impairments are already present. Measurement 
of visual acuity of those with the disease using standard methods is difficult 
and unreliable due to the age of those affected and their cognitive, language, 
and motor impairments.

Pursuant to an agreement between OAL and REGENXBIO Inc., a leading 
clinical-stage biotechnology company seeking to improve lives through the 
curative potential of gene therapy, a pilot study was conducted at 
Universitätsklinikum Hamburg-Eppendorf (UKE) in Hamburg, Germany, using OAL's 
objective optokinetic nystagmus (OKN) detection technology to determine its 
usefulness in monitoring children with CLN2 disease. 

OAL's technology uses a camera to measure the movement of each eye while the 
child looks at a screen displaying a "drifting stimulus" pattern. Data from the 
camera is used by OAL's proprietary algorithms to detect OKN, an involuntary 
motion of the eye that typically occurs as a reflex response to the visual 
stimuli. 

Visual acuity read-outs using OAL's technology were compared to measurements of 
central retinal thickness (CRT) obtained under anaesthesia. The results of the 
pilot study demonstrate a high correlation between visual acuity results 
determined using OAL's technology and the CRT measurements. Therefore, 
determining visual acuity results using OAL's technology could potentially be 
used as a significantly less subjective method for measuring visual acuity of 
those with CLN2 disease. Further details were presented by REGENXBIO at the 
ARVO 2021 Annual Meeting in a presentation titled "Pilot Study of Novel 
Optokinetic Nystagmus-Based Visual Acuity Test in Children with CLN2 Disease."

As a result of the successful pilot study, REGENXBIO has signed an agreement 
with OAL to use OAL's technology in future studies for the development of 
RGX-381, REGENXBIO's gene therapy candidate to treat ocular manifestations of 
CLN2 disease.

Christina Ohnsman, M.D., Senior Clinical Development Lead of REGENXBIO, who 
presented the work at ARVO, said: "We are pleased with the results of this 
study.  The objective visual acuity measurement obtained using OAL's technology 
may allow REGENXBIO to obtain further data on the range, severity and impact of 
visual impairment in patients with CLN2 disease as we advance our gene therapy 
candidate to treat ocular manifestations of the disease."

Adam Podmore, Chief Executive Officer of OAL, said: "It is exciting to be 
working with REGENXBIO and to have OAL's technology potentially be deployed in 
REGENXBIO's studies."

About Objective Acuity ("OAL")
OAL aims to develop objective vision tests for children and adults. The tests 
do not require children to provide a response, unlike existing picture or 
letter chart tests. We are developing two tests, a vision screening test for 
young children displayed on an iPad Pro and a threshold visual acuity test.

OAL's patented technology involves a "drifting stimulus". The camera measures 
movement of the eyes and OAL's proprietary algorithms use data from the camera 
to detect optokinetic nystagmus (OKN). OKN is an involuntary sawtooth motion of 
the eye that typically occurs as a reflex response to the visual stimuli. The 
test is 100% objective and the system indicates the presence or absence of an 
OKN response. Intuitively, the presence of OKN indicates that the child can see 
the drifting stimulus, while the absence of OKN indicates the opposite. 

SOURCE  Objective Acuity Limited