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UNITY BIOTECHNOLOGY UNITY Biotechnology Announces Improvement in Visual Acuity Sustained Through 24 Weeks Following Single Dose of UBX1325 in Phase 1 Study of Patients with Advanced Vascular Eye Disease November 9 , 2021 Patients with diabetic macular edema in higher dose cohorts showed a mean BCVA gain of approximately 10 ETDRS letters sustained through 24 weeks after a single intravitreal injection Patients with wet age - related macular degeneration showed improvement in visual acuity through 12 weeks supporting initiation of Phase 2 study in AMD UNITY to host investor call with retinal experts Arshad Khanani , M.D. , M.A. , and Robert Bhisitkul , M.D. , Ph.D. , today , November 9 , 2021 at 8:00 a.m. ET SOUTH SAN FRANCISCO , Calif . , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- UNITY Biotechnology , Inc. ( " UNITY " ) [ NASDAQ : UBX ] , a biotechnology company developing therapeutics to slow , halt , or reverse diseases of aging , today announced 24 - week data from its Phase 1 single ascending dose ( SAD ) safety study of UBX1325 in patients with advanced disease from diabetic macular edema ( DME ) or wet age - related macular degeneration ( AMD ) . A majority of patients with DME across all doses had rapid improvements in vision , and patients in the higher dose cohorts showed a mean gain of 9.5 ETDRS letters in best - corrected visual acuity ( BCVA ) at 24 weeks following a single injection of UBX1325 . Similarly , a majority of wet AMD patients treated with UBX1325 showed rapid gains in visual acuity , which were maintained through 12 weeks . In most patients , central subfield thickness ( CST ) remained stable through the study period . UBX1325 Well - Tolerated at All Doses The study enrolled a total of 19 patients with advanced DME ( n = 8 ) and wet AMD ( n = 11 ) for whom anti - VEGF therapy was no longer considered beneficial . UBX1325 was well - tolerated at all doses tested ( through 10 mcg ) with no dose - limiting toxicities and no reported incidence of inflammation . Results from Patients with Diabetic Macular Edema Treated with UBX1325 The Phase 1 data show rapid improvements in visual acuity as measured by BCVA in patients with DME , with the majority of patients demonstrating sustained responses through 24 weeks : • ⚫Across all DME patients enrolled ( n = 8 ) , there was an improvement in visual acuity in 6 of 8 patients at 12 weeks , and in 5 of 8 patients at 24 weeks • ⚫In the higher dose cohorts ( 5 , 10 mcg ) , patients had a mean improvement of 9.5 ETDRS letters from baseline at 24 weeks • ⚫Amongst all DME patients , 62.5 % gained 5 or more letters at 24 weeks , and 50 % gained 10 or more letters also at 24 weeks • • In the majority of patients with DME , CST remained stable through 24 weeks " A 10 letter gain in DME patients , maintained through six months , is an impressive outcome , and is particularly noteworthy considering that it was achieved with a single injection , " said Arshad Khanani , M.D. , M.A. , managing partner of Sierra Eye Associates . " Hard - to - treat patients require as many as 10 injections in the first year of treatment to see full benefits from currently available anti - VEGF therapies . A treatment that reduces the frequency of injections while showing meaningful and sustained improvements in BCVA would be of huge value for patients and physicians . " Results from Patients with Wet Age - Related Macular Degeneration Treated with UBX1325 The Phase 1 study included 11 wet AMD patients ( 4 in the SAD cohort , and an additional 7 in an expansion cohort ) . A majority of patients showed rapid improvements in visual acuity : • ⚫Across all evaluable patients with wet AMD enrolled ( 10 of 11 ) , there was an improvement in visual acuity in 7 of 10 patients at 8 weeks , and in 5 of 10 patients at 12 weeks ⚫⚫2 of 3 patients in the SAD cohort maintained their visual acuity gain through 24 weeks ⚫⚫Within the ten evaluable patients with wet AMD , CST remained stable through 12 weeks ; this trend was also observed in the three evaluable patients with wet AMD at 24 weeks , and 2 of those 3 patients showed resolution of most subretinal fluid " Patients with wet AMD will lose vision without treatment and have a worse prognosis than patients with DME , which is why the letter gain seen in the AMD cohort is so meaningful , " said Robert Bhisitkul , M.D. , Ph.D. , professor of ophthalmology and director of the Retina Fellowship at University of California , San Francisco . " The efficacy that we are seeing in AMD patients provides a convincing rationale for advancing this program into additional clinical studies . " " We have now followed advanced DME and AMD patients for 24 weeks , and see clear evidence of rapid and sustained responses from a single