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Adverum Provides Update on ADVM - 022 and the INFINITY Trial in Patients with Diabetic Macular Edema July 22 , 2021 -- Based on latest analyses , company is revising ADVM - 022 development plan to focus on wet AMD and low doses ( 2 x 10 ^ 11 vg / eye and lower ) ; no longer planning development for DME -- · Company to host conference call and webcast today at 1:30 pm PT / 4:30 pm ET -- REDWOOD CITY , Calif . , July 22 , 2021 ( GLOBE NEWSWIRE ) -- Adverum Biotechnologies , Inc. ( Nasdaq : ADVM ) , a clinical - stage gene therapy company targeting unmet medical needs in ocular and rare diseases , today provided an update on the ADVM - 022 development program following a thorough review of data available from the INFINITY clinical trial in patients with diabetic macular edema ( DME ) and the OPTIC clinical trial in patients with wet age - related macular degeneration ( wet AMD ) . The data from the studies show marked differences in the safety profile between the two patient populations and between the low ( 2 x 10 ^ 11 vg / eye ) versus high ( 6 x 10 ^ 11 vg / eye ) doses . Adverum no longer plans future development for DME after a dose - limiting toxicity ( DLT ) not seen before in ocular gene therapy or anti - VEGF treatment has been observed at the high dose ( 6 x 10 ^ 11 vg / eye ) in patients with DME . The company is planning to evaluate ADVM - 022 , a single intravitreal ( IVT ) injection gene therapy , at low doses ( 2 x 10 ^ 11 vg / eye and lower ) and with alternative prophylactic regimens in a future Phase 2 clinical trial in wet AMD . Wet AMD and DME have different pathophysiological causes with different risk factors . While the root cause of the DLT is not yet known , diabetic patients with DME typically have multiple underlying comorbidities , such as severe vascular disease , which can contribute to inflammatory factors that may induce an increase in vascular permeability and disrupt the blood - ocular barrier in DME patients.i As disclosed in late April 2021 , Adverum immediately unmasked INFINITY and began closely monitoring all patients treated to date with ADVM - 022 following a Suspected Unexpected Serious Adverse Reaction ( SUSAR ) of hypotony in the treated eye of a patient with DME who received a single high dose of ADVM - 022 . Additional patients in INFINITY treated with a single high dose of ADVM - 022 have , despite close monitoring and aggressive treatment , experienced adverse events that have included rapid , clinically - relevant decreases in intraocular pressure refractory to steroids and requiring subsequent additional treatment . These events occurred 16-36 weeks after treatment with the high dose . No similar clinically - relevant events have been observed to date in DME patients in INFINITY treated with the low dose or to date in any wet AMD patients in OPTIC treated at either the high or low dose . The company is closely managing patient care working with the data monitoring committee ( DMC ) , its scientific advisory board ( SAB ) , leading retina specialists , and investigators . All clinical trial sites and the U.S. Food and Drug Administration ( FDA ) have been advised of these cases . " Our primary focus remains patient safety , " said Laurent Fischer , M.D. , president and chief executive officer at Adverum Biotechnologies . " We deeply appreciate the continued expertise shared by the DMC , the SAB , retina specialists , and investigators to guide best patient care decisions . Gene therapy is a new and very promising , yet challenging field , as we work to develop durable treatments for patients . Our team is grateful for all of the patients and investigators participating