Adverum Biotechnologies, Inc., a U.S. based biotechnology company that develops innovative therapies for ocular and rare diseases, has announced its first patient data from the OPTIC phase 1 clinical study of ADVM-022, an intravitreal injection gene therapy for wet age-related macular degeneration (AMD).
Reportedly, Charles C. Wykoff M.D., Ph.D., director of research, Retina Consultants of Houston, presented the data at New York’s Atlantic Coast Retina Club Macula 20/20 annual meet.
As per a recent report, ADVM-022 was seen to remain well-tolerated among the first cohort with no signs of procedure-related or drug-related serious adverse events (SAEs), no adverse events fulfilling the conditions for dose-limiting toxicities (DLTs) and no drug-related systemic adverse events.
However, six patients in the trial suffered from low-grade inflammation which was mostly moderate to mild and was responsive to steroid eye drops. Moreover, one particular ocular SAE, retinal detachment, was reported that was not related to the administration procedure or ADVM-022.
According to a statement, Aaron Osborne, MBBS, Chief Medical Officer, Adverum, said that these latest findings are promising as they carry on supporting the efficacy, durable and safety clinical profile of the drug.
The therapy has the potential to alter the treatment paradigm for patients suffering from wet AMD. The current standard of care, anti-VEGF injections, possess a substantial treatment burden and real-world findings data indicate that vision outcome is suboptimal because of undertreatment.
Osborne claims that in the company’s OPTIC’s first cohort it continues to observe anatomical improvements and stable vision being retained out to an average of 44 weeks after one ADVM-022 injection in these hard-to-treat subjects who earlier needed regular anti-VEGF injections.
Adverum is looking forward to delivering longer-term findings from the 24-week data from the second cohort and initial cohort of OPTIC at the Exudation, Angiogenesis and Degeneration 2020 symposium, said Osborne.
Source Credit: http://investors.adverum.com/news-releases/news-release-details/adverum-biotechnologies-reports-additional-clinical-data-first-0
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