This article is more than 5 years old. Information may no longer be current.
In-office gene therapy injection maintains BCVA through 24 weeks in wet AMD patients
SAN FRANCISCO — Patients with wet age-related macular degeneration in the OPTIC trial treated with one in-office injection of ADVM-022, a gene therapy specifically designed for long-term intraocular VEGF suppression, maintained best corrected visual acuity and experienced improved central subfield thickness from baseline through 24 weeks’ follow-up, according to a speaker here.
“In the 8 months prior to OPTIC, the six patients in the first cohort received 37 injections of aflibercept. With a median of 8 months’ follow-up after intravitreal gene therapy, no rescue injections were required,” Szilard Kiss, MD, said at Retina Subspecialty Day at the American Academy of Ophthalmology meeting.
Kiss presented 24-week results of the OPTIC phase 1 trial, a 2-year multicenter study of ADVM-022 (Adverum Biotechnologies) for the treatment of AMD. The six patients in the study were given an injection of Eylea (aflibercept, Regeneron) 1 to 2 weeks before baseline and then a single in-office intravitreal injection of ADVM-022. Safety and tolerability were evaluated at week 24 as the primary outcomes, with best corrected visual acuity, central subfield thickness and the need for rescue injections of aflibercept as the secondary outcomes, Kiss said.
At week 24, patients experienced no serious adverse events and no drug-related non-ocular adverse events, and no adverse events met the criterial for dose-limiting toxicity. There were 19 ocular adverse events possibly related to ADVM-022; 14 events were mild, and five were moderate.
Patients maintained BCVA from baseline, experiencing a mean two letter loss, and had a mean 52.7 µm improvement in central subfield thickness.
No rescue anti-VEGF injections were required, and fluid resolved on OCT by week 24.
Through Oct. 1, the patients maintained their BCVA and improvements in central subfield thickness, and still no rescue injections were required, Kiss said.
Enrollment for cohort three is ongoing, he said. – by Robert Linnehan
Reference:
Kiss S. 24-week results of phase 1 study of intravitreal gene therapy with ADVM-022 for neovascular AMD (OPTIC trial). Presented at: American Academy of Ophthalmology annual meeting; October 11-15, 2019; San Francisco.
Disclosure: Kiss reports he is a consultant and adviser for and has equity with Adverum Biotechnologies, Regenxbio and Fortress Bio; is a consultant for and adviser with Genentech/Roche and Novartis; is a consultant and adviser for and receives research grant support from Optos; and has intellectual property related to gene and cellular therapy assigned to Weill Cornell/Cornell University.