OCT 01, 2022
Study Results: Gene Tx for Geographic Atrophy
Data from a phase 1 study of the safety and efficacy of JNJ-1887 (Johnson & Johnson) in geographic atrophy (GA) indicate that the study met its primary safety objective, Michael Nathan Cohen, MD, reported on Saturday at Retina Subspecialty Day. After 24 months of extended follow-up, all three doses of the gene therapy were safe and well-tolerated, said Dr. Cohen, an investigator in the study.
Study design. For this study, the researchers assigned 17 participants into three dose-escalation cohorts, with three in each of the low- and medium-dose cohorts and 11 in the high-dose cohort.
Key inclusion criteria included BCVA of 20/80 or worse in the study eye, BCVA of 20/800 or better in the fellow eye, and total GA lesion size of 5 mm2 to 20 mm2 in the study eye. Exclusion criteria included prior active choroidal neovascularization (CNV) in the study eye.
“Of note, no steroid prophylaxis was administered during the study,” Dr. Cohen said.
Results. Dr. Cohen outlined the following outcomes:
- Adverse events. Five instances of intraocular inflammation were observed; these were mild and managed with either topical corticosteroids or observation. No cases of endophthalmitis occurred, and there were no instances of new-onset CNV or wet age-related macular degeneration in treated eyes. During the panel discussion, Dr. Cohen emphasized that the cases of inflammation were mild and resolved quickly.
- GA lesion growth rate. The growth rate of the GA lesion was similar in all three dosing cohorts. In those who received the highest dose of JNJ-1887, the lesion growth rate continued to decrease up to the final measurement at the 24-month mark.
Next steps. These are very preliminary results and more study is needed, Dr. Cohen said.—Jean Shaw
Financial disclosures: Dr. Cohen: Alimera: C; Allergan: C; Keeler Instruments: C.
Disclosure key: C = Consultant/Advisor; E = Employee; EE = Employee, executive role; EO = Owner of company; I = Independent contractor; L = Lecture fees/Speakers bureau; P = Patents/Royalty; PS = Equity/Stock holder, private corporation; S = Grant support; SO = Stock options, public or private corporation; US = Equity/Stock holder, public corporation For definitions of each category, see aao.org/eyenet/disclosures.
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