OSLI Retina

August 2020

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476 Ophthalmic Surgery, Lasers & Imaging Retina | Healio.com/OSLIRetina News and Notes News and Notes AGTC Updates Plan for Retinitis Pigmentosa Gene Therapy Trials Applied Genetic Technologies Corporation has received written feedback from the U.S. Food and Drug Administration (FDA) about its potential X-linked retini- tis pigmentosa treatment and updated its development plan accordingly, accord- ing to a press release. The feedback focused mostly on the design and execution of a registration trial and future submissions. AGTC is conducting clinical trials of adeno-asso- ciated virus-based gene therapies for rare diseases, including X-linked retinitis pigmentosa (XLRP). "We are pleased with the productive feedback from the FDA and are modify- ing our development program based on their recommendations to advance our XLRP gene therapy candidate," Sue Washer, president and CEO, AGTC, said in the release. The plan features an expansion of the current phase 1/2 trial in which about 20 patients will be treated in two masked dosing arms to collect additional data, including a mobility test. Dosing is expected to begin in the fourth quarter. The revised phase 2/3 trial design will likely include two masked active arms and a control group, with visual sensitivity serving as the primary endpoint. Sup- plemental endpoints will include a mobility test. This trial is expected to begin in the first quarter of 2021. Originally published on www.Healio.com on July 23, 2020. Ophthalmic Surgery, Lasers & Imaging Retina® (ISSN-2325-8160, Canadian BN-12978 0466 RT ) is published 12 times per year by SLACK Incorporated®, and is an official publication of ARVO/ISIE. Publication Office: SLACK Incorporated®, 6900 Grove Road, Thorofare, NJ 08086-9447. Telephone (856) 848-1000. Printed in the USA. Periodicals Class Postage Paid at Deptford, NJ 08096 and at additional mailing offices. 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Readers with queries about the Journal's policies on error correction, version control, journal of record, ancillary material, or archiving should contact osli@healio.com. The Journal staff have no financial relationships to disclose. Financial disclosures for the Editor and members of the Editorial Board are on file with the editorial office. Indexed in: Medline/PubMed, ProQuest, EMCare, EMBASE, Science Citation Index, Current Contents/Clinical Medicine, BioEn- gineering Abstracts, CAB Abstracts, and SCOPUS. Follow OSLIJournal OSLI Retina SLACK Incorporated 6900 Grove Road Thorofare, NJ 08086-9447 Phone: 856-994-9900 Email: osli@healio.com Healio.com/OSLIRetina Chief Content Officer Joan-Marie Stiglich, ELS EDITORIAL Senior Editorial Director David W. Mullin Executive Editor Cara Dickinson SALES Chief Commercial Officer Matthew J. 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