Pulsar trial aflibercept Presented at the 23. Presented at the 127. What are some of the clinical outcomes from this trial that stand out to you? The Phase 3 PULSAR trial evaluated the safety and efficacy of intravitreal injections of 8 mg aflibercept in eyes with nAMD. The PULSAR Study Aug 10, 2023 · 88% of all aflibercept 8 mg patients were on a ≥12-week dosing interval at the end of two years 78% of all aflibercept 8 mg patients maintained ≥12-week dosing intervals throughout the two Sep 28, 2023 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at Oct 5, 2023 · Reviewed by Chui Ming Gemmy Cheung, MD. Tien Y Wong, 1. Free Paper Session 3: Intravitreal aflibercept 8 mg injection in patients with neovascular age-related macular degeneration: 60-week results from the phase 3 PULSAR trial. 11. Sep 11, 2024 · Intraocular pressure outcomes with intravitreal aflibercept 8 mg and 2 mg in patients with neovascular age-related macular degeneration through Week 96 of the PULSAR trial: Paolo Lanzetta, MD: Oral Presentation at Speakers’ Corner Date: September 19 Time: 13:50–13:55 CEST Session 2: AMD Apr 29, 2024 · One-year results from the PULSAR and PHOTON trials were recently published in The Lancet. Both trials were conducted in multiple centers globally, including Canada, with similar designs and endpoints. 8) 28 (2. One randomized, double-blind, active-controlled, phase III trial (PULSAR, N = 1,009) demonstrated that aflibercept 8 mg every 12 weeks and every 16 weeks was noninferior to aflibercept 2 mg every 8 weeks in improving best-corrected visual acuity (BCVA) from baseline over 48 weeks of treatment in adult patients with treatment-naive nAMD. Dec 21, 2024 · Boyer D, PHOTON study investigators (2023) Intravitreal Aflibercept injection 8mg for DME: 48-week results from the phase 2/3 PHOTON Trial. Both the PULSAR trial in wet AMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with aflibercept . May 13, 2024 · Here are the results recorded at week 96 of the Pulsar trial: Seventy-five percent of 8q12 patients and 70% of 8q16 patients maintained ≥12- and ≥16-week dosing intervals. . Wong, MD, FRCS(C) Subgroup Analyses From the Phase 3 PULSAR Trial of Aflibercept 8 Jun 29, 2023 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at Oct 5, 2023 · EYLEA® HD (aflibercept) Injection 8 mg Two-year Results from Pivotal PULSAR Trial in Wet Age-related Macular Degeneration Presented at EURETINA Aflibercept 8 mg monotherapy shows maintained efficacy over 96 weeks, with the ability to extend dosing intervals beyond every 16 weeks, in patients with PCV in the PULSAR Phase 3 trial You will receive an email whenever this article is corrected, updated, or cited in the literature. Available on Jun 27, 2023 · The two-year data from the pivotal PULSAR trial for aflibercept 8 mg in wet age-related macular degeneration are expected in the third quarter of 2023, and the two-year data from both PHOTON and Jan 8, 2024 · The EU approval is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DME. May 6, 2024 · Recent three clinical trials, PULSAR that evaluated aflibercept 8 mg and TENAYA and LUCERNE faricimab trials met non-inferiority in terms of mean change in VA compared to aflibercept 2 mg given as Methods : PULSAR (NCT04423718) is a double-masked, 96-week, Phase 3 trial. We would like to show you a description here but the site won’t allow us. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or EYLEA every 8 weeks. 1 Aflibercept 8 mg: 48-Week results from the Phase 3 clinical trial program in nAMD and DME The PULSAR and PHOTON trials Nitin Verma1 – on behalf of the PULSAR study investigators Reference: 1. trials of aflibercept 8 mg • Safety data from 3 multi-center clinical trials comparing the efficacy and safety of aflibercept 8 mg versus 2 mg were pooled (Figure 1): – The phase 2 CANDELA trial and Phase 3 PULSAR trial in treatment-naïve patients with nAMD – The phase 2/3 PHOTON trial in treatment-naïve and previously treated patients Jan 18, 2024 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA Mar 8, 2024 · The 96-week, phase 3 PULSAR trial was conducted across 223 global sites, in which adults with nAMD were randomized to aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or aflibercept 2 mg every 8 weeks, after three initial monthly doses in all groups. 3 mg/ml solution for injection) has been approved in the EU, Japan, and other markets for the treatment of nAMD and DME. Treatment intervals could be shortened to as little as 8 weeks from Week 16 or extended up to 24 weeks. May 7, 2024 · Results from the double-masked, PULSAR trial found that the higher-dose aflibercept 8 mg was non-inferior to aflibercept 2 mg in improving vision outcomes. The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens (8q12, 8q16) versus Eylea (aflibercept 2 mg) dosed every 8 weeks (2q8) with the primary endpoint at week 48. Nov 10, 2023 · Recommendation by Committee for Medicinal Products for Human Use (CHMP) based on positive results from PULSAR clinical trial in neovascular (wet) age-related macular degeneration (nAMD) and PHOTON trial in diabetic macular edema (DME) / If approved by European Commission, aflibercept 8 mg will be the only drug providing extended treatment interv Aug 10, 2023 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at Aflibercept 8 mg in Patients with nAMD: Phase 3 PULSAR Trial 96-Week Results Hideki Koizumi,1 Jean-François Korobelnik,2,3 Paolo Lanzetta,4,5 on behalf of the PULSAR study investigators 1Department of Ophthalmology, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan 2CHU de Bordeaux, Service d’Ophtalmologie, Bordeaux, France May 10, 2023 · Global phase III QUASAR study will assess the efficacy and safety of aflibercept 8 mg in macular edema secondary to retinal vein occlusion (RVO) / Study comes after positive data from the phase III PULSAR trial in neovascular (wet) age-related macular degeneration (nAMD) and phase II/III PHOTON trial in diabetic macular edema (DME) / QUASAR is e Mar 23, 2024 · PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Marion Munk reviews the Phase 3 clinical trial of high-dose aflibercept (8 mg) in neovascular AMD, emphasizing how this new therapy could alleviate the treatment burden for patients while providing superior outcomes. EYLEA ® HD (Aflibercept, 8 mg). 3 Notably, aflibercept 8 mg offered the ability to extend further between injections, with every-12-week (Q12W) and every-16-week (Q16W) intervals showing non-inferiority to every-8-week Nov 17, 2023 · The PULSAR study was a randomized, multicenter, double-masked pivotal trial of ≥1,000 patients which compared aflibercept 2 mg every 6 weeks (Q6W), aflibercept 8 mg every 12 weeks (Q12W), and aflibercept 8 mg every 16 weeks (Q16W). In the 48-week results of the PULSAR phase 3 trial in patients with Wet AMD (N=1009), the EYLEA HD Q12W and Q16W treatment arms demonstrated noninferiority in mean change in BCVA from baseline compared with EYLEA ® (aflibercept) Injection 2 mg Q8W with fewer injections and a comparable safety profile. 6) Aflibercept Exposure CANDELA Phase 2, multi-center, randomized, Trial Design PULSAR and PHOTON Dec 19, 2022 · We took to the streets at APVRS 2022 in Taipei to gauge sentiment on the stunning new aflibercept 8 mg data from the PULSAR and PHOTON trials. PHOTON in DME and PULSAR in wAMD are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. of nAMD. 2) 69 (5. on behalf of the aflibercept 2 mg is hypothesized to provide longer effective vitreal concentrations and enable a more sustained effect on VEGF signaling Here, we present the results of the ongoing, randomized, double-masked, 96-week, Phase 3 PULSAR trial in patients with treatment-naïve nAMD PIEGF„ VEGE uls Purpose : PULSAR (NCT04423718) is an ongoing, double-masked, 96-week, Phase 3 trial in patients aged ≥50 years with treatment-naïve neovascular age-related macular degeneration randomly assigned 1:1:1 to intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12, 8q16) or 2 mg every 8 weeks (2q8), each after three initial monthly injections Aflibercept 8 mg in Patients with Neovascular Age-Related Macular Degeneration: Phase 3 PULSAR Trial 96-Week Results. Nov 13, 2023 · Both the PULSAR trial in wet AMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with aflibercept injection 8 mg demonstrating non-inferior and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses, compared to an EYLEA 8-week dosing regimen after Apr 29, 2024 · Two-year (96 week) results from the PULSAR trial investigating EYLEA HD in patients with wet age-related macular degeneration (wAMD), compared to EYLEA, which will feature a post-hoc analysis on Jan 24, 2024 · At week 48 in the PULSAR clinical trial, aflibercept 8 mg, dosed with extended treatment intervals (every 12 or every 16 weeks) demonstrated comparable visual acuity to the standard of care Eylea ™ (aflibercept 2 mg) with a fixed 8-week treatment interval, following three initial monthly doses. As published in The Lancet, both PULSAR in wAMD (N=1,009) and PHOTON in DME (N=658 Pooled Safety Analysis of Aflibercept 8 mg in the and PULSAR Trials Carolyn Majcher, 01), FAAO, on behalf of CANDELA, PHOTON, and PULSAR study investigators Oklahoma College of Optometry, Northeastern State University, Talequah, Oklahoma CANDELA, PHOTON, 266 Aflibercept 8 mg pooled n=1217 654 (53. 3 Movement Apr 17, 2023 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at Jan 1, 2023 · Shortly before the 2022 American Academy of Ophthalmology annual meeting, positive 1-year data from the PULSAR and PHOTON trials read out. 1 These trials investigated the clinical efficacy and safety of 8 mg aflibercept relative to 2 mg aflibercept in both AMD and DME. Xin Zhang, 3. Safety data for PHOTON and PULSAR were pooled up to Week 96 and CANDELA through Week 44. Aug 19, 2023 · According to the news release, the approval is based on the 48-week results of PULSAR and PHOTON – two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA (aflibercept) Injection 2 mg. May 6, 2024 · Dr. announced positive, 2-year topline data from the pivotal PULSAR trial assessing the use of aflibercept 8 mg in patients diagnosed with wet age-related macular degeneration (AMD). These proportions are comparable to those for the overall patient populations in the PULSAR trial. Nov 5, 2022 · About trial design of PULSAR and PHOTON. A PULSAR Phase 3 Trial Post-hoc Analysis: Evaluating the Timing and Magnitude of Control of Disease Activity with Aflibercept 8 mg and Faricimab, Applying Similar Disease Activity Criteria Across Different Pivotal Phase 3 Trials for nAMD Michael W. Presented Jun 27, 2023 · Both trials reported those treated with aflibercept 8 mg in PULSAR (n = 673) and PHOTON (n = 491) met the primary endpoint of noninferiority in vision gains for both 12- and 16-week dosing regimens at 48 weeks, compared to patients treated with an aflibercept 8-week dosing regimen (PULSAR, n = 336; PHOTON, n = 167). Black or African American patients were excluded due to small sample size. Annual Meeting of the American Academy of Ophthalmology, November 3–6, 2023 A 96-week PULSAR Phase 3 trial post-hoc analysis: Rapid and sustained fluid control with aflibercept 8mg every 12 weeks or longer, as defined by fluid-free status at Weeks 16, 48, and 96 Objective: This analysis evaluated the pooled safety of aflibercept 8 mg and 2 mg for up to 96 weeks across the CANDELA, PULSAR, and PHOTON trials Aflibercept 8 mg pooled (n=1217) 10,067 8. A subgroup analysis of the phase 3 PULSAR Trial, which evaluated intravitreal aflibercept 8-mg monotherapy (Eylea, Regeneron Pharmaceuticals) compared to aflibercept 2 mg to treat polypoidal choroidal vasculopathy (PCV), showed robust increases in the best-corrected visual acuity (BCVA) compared with baseline at week 48. The results provide strong evidence of the comparable visual and anatomic outcomes of aflibercept 8 mg administered at Intravitreal Aflibercept 8 mg Injection: Results From the PULSAR and PHOTON Trials. Nov 7, 2023 · In another poster, the Phase III PULSAR trial further went on to analyse the relationship between early fluid resolution in the initial treatment phase and dosing intervals and to reveal whether this may be used as a biomarker to estimate how likely it is for nAMD patients to attain longer dosing intervals with aflibercept 8mg. Singh, MD: Recently, we’ve had the high-dose aflibercept 8 mg, which was approved by the FDA and PULSAR and PHOTON. Available on Aug 10, 2023 · PULSAR (N= 1,009) is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg 12-week (n=335) and 16-week (n=338) dosing regimens compared to an 8-week Pooled Safety Analysis of Aflibercept 8 mg in the CANDELA, PHOTON, and PULSAR Trials . Department of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany Mar 8, 2024 · The lead sponsors of the trials were Bayer for PULSAR and Regeneron for PHOTON. 1,2 Oct 5, 2023 · Regeneron announced the first presentation of positive 2-year (96 weeks) results from the PULSAR trial investigating Eylea HD (aflibercept) injection 8 mg with 12- and 16-week dosing regimens, compared to Eylea (aflibercept) injection, in patients with wet age-related macular degeneration (AMD). Inclusion criteria: Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye Aug 11, 2023 · “In the PULSAR trial, aflibercept 8 mg achieved impressive durability, while importantly maintaining visual acuity gains from year one through year two. Comparative clinical efficacy Aug 10, 2023 · About the Aflibercept 8 mg Clinical Trial Program PULSAR in wAMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. 3 (2. Singapore Eye Research Institute, Singapore National Eye Centre, Singapore; Tsinghua Medicine, Tsinghua University, Beijing, China . Karen Chu, 4. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to aflibercept 2 mg (Eylea 40 mg/ml) with a fixed 8-week treatment Oct 5, 2023 · The PULSAR trial met its primary endpoint, with EYLEA HD patients achieving clinically equivalent vision gains to EYLEA at 48 weeks. Mar 8, 2024 · “The publication of 48-week results from PULSAR and PHOTON in The Lancet are a recognition of the important advancement Eylea HD has made in retinal care,” said David M Brown, MD, FACS, director of research at Retina Consultants of Texas and a trial investigator in a press release from Regeneron. 7) 75 (6. May 7, 2024 · Dr. 2 Methods : PULSAR (NCT04423718) is an ongoing, double-masked, 96-week, Phase 3 trial: patients aged ≥50 years with nAMD were randomly assigned 1:1:1 to receive 8q12, 8q16 or 2q8. All patients received three initial monthly doses. Aug 18, 2023 · The FDA approval is based on the 48-week results of PULSAR and PHOTON – two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA (aflibercept) Injection 2 mg. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or May 23, 2023 · With Aflibercept 8 mg vs Patients With Shortened Treatment Intervals: Phase 3 PULSAR Post Hoc Analysis, David R. These data are consistent with the results from the PHOTON trial in diabetic macular edema, with both trials demonstrating a consistent safety profile with substantially fewer treatments than Mar 8, 2024 · PULSAR and PHOTON are two double-masked, active-controlled pivotal trials evaluating EYLEA HD compared to EYLEA. Added value of this study . We report 48-week results for the phase 2/3 PHOTON trial, which evaluated the efficacy and safety of aflibercept 8 mg versus 2 mg in patients with DMO. Apr 29, 2024 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at Dec 16, 2022 · But in both the PULSAR and PHOTON trials of 8 mg aflibercept for nAMD and DME, this interval was astonishingly extended to q12 and q16. Sep 11, 2024 · A 96-week PULSAR Phase 3 trial post-hoc analysis: Rapid and sustained fluid control with aflibercept 8mg every 12 weeks or longer, as defined by fluid-free status at Weeks 16, 48, and 96 Nov 1, 2023 · Early Fluid Resolution Association With Treatment Interval Maintenance at Week 48 in Patients Receiving Aflibercept 8 mg: Phase 3 PULSAR Trial* PO474 ePoster: Varun Chaudhary, M. The baseline characteristics and initial distribution of patients across visual acuity health states in the model were based on the PULSAR trial, which randomized patients with nAMD (mean age of 74. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria for Apr 17, 2023 · Notable podium presentations will highlight the pivotal aflibercept 8 mg trials PULSAR and PHOTON, respectively, in wAMD and DME with 48-week efficacy and safety results, in addition to an Oct 12, 2023 · Lanzetta P. on behalf of CANDELA, PHOTON, and PULSAR study investigators. Moorfields Eye Hospital, London, UK. This 4-times higher molar dose of aflibercept is hypothesized to provide longer effective vitreal concentrations and enable a more sustained effect on vascular endothelial growth factor (VEGF) signaling. Mar 23, 2024 · Methods. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or Jan 24, 2024 · The application was accepted by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) on the merits of the Phase III PULSAR trial data, which has demonstrated unprecedented durability and treatment interval lengths and a safety profile similar to that of Eylea (aflibercept 2mg), one of the current Aug 20, 2024 · In 2023, aflibercept 8 mg was launched as a new anti-VEGF drug following a phase 3 clinical trial, the PULSAR trial, with aflibercept 2 mg serving as the control drug . D Jun 28, 2023 · Patients treated with aflibercept 8 mg in both trials had 3 initial monthly doses, and patients treated with aflibercept received 3 initial doses in PULSAR and 5 in PHOTON. Marion Munk examines the Phase 2/3 clinical trial of high-dose aflibercept (8 mg) in diabetic macular oedema, presenting key outcomes and clinical implications of the data. Sep 10, 2022 · Patients treated with aflibercept 8 mg in both trials had 3 initial monthly doses, and patients treated with aflibercept received 5 initial monthly doses in PHOTON and 3 in PULSAR. Sobha Sivaprasad, 1. today announced positive, two-year, topline data from the pivotal PULSAR trial investigating aflibercept 8 mg in patients with wet age-related macular degeneration. These findings supported the assessment of aflibercept 8 mg in two pivotal trials, one in patients with DMO (PHOTON), and one in patients with nAMD (PULSAR; NCT04423718). The results provide strong evidence of the comparable visual and anatomic outcomes of aflibercept 8 mg administered at extended dosing intervals to aflibercept 2 mg up to week 48. Purpose : In PULSAR (NCT04423718), the primary endpoint of change from baseline in best-corrected visual acuity at Week 48 (non-inferiority margin at 4 letters) was met with intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16) vs aflibercept 2 mg every 8 weeks (2q8). Varun Chaudhary, M. 5, +7. 1) 86. Presented at angiogenesis, exudation, and degeneration virtual meeting. John, Australia, Clinical Professor University of Tasmania, Clinical Associate Professor University of May 7, 2024 · Dr. Dr. PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Aflibercept 8 mg showed unprecedented durability Intravitreal Aflibercept 8 mg in Patients with PCV: 96-Week Subgroup Analysis from Phase 3 PULSAR Trial Tien Y Wong, 1 Chui Ming Gemmy Cheung,2 Jeffrey S Heier,3 Xin Zhang,4 Tobias Machewitz,5 Andrea Schulze,5 Zoran Hasanbasic,4 Sergio Leal,4. Conclusions: Baseline Subgroup Analyses at Week 48. Give me some details on aflibercept first. This aflibercept 8q12, 8q16, and 2q8 PCV subgroups (+9. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at Week 48 (non-inferiority margin at 4 letters). Sergio Leal, 3. These data are consistent with the results from the PHOTON trial in diabetic macular edema, with both trials demonstrating a consistent safety profile with substantially fewer treatments than Eylea. 3 days ago · Aflibercept 8 mg was initially approved by the FDA in August 2023 for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR), based on pivotal data from the Phase 3 PULSAR and PHOTON trials. In these trials, the safety of aflibercept 8 mg was consistent with the established safety profile of aflibercept. a. 00: PULSAR trial to inform clinical efficacy of aflibercept 8 mg. Aug 14, 2023 · Regeneron Pharmaceuticals, Inc. on behalf of the PULSAR and PHOTON study investigators. The trial design was a noninferiority study with the implied “superiority Subgroup analyses from the Phase 3 PULSAR trial of aflibercept 8 mg in patients with treatment-naïve neovascular age-related macular degeneration You will receive an email whenever this article is corrected, updated, or cited in the literature. on behalf of the PULSAR study investigators. The constant ebb and flow of new drug announcements is a rhythmic lullaby for hardworking ophthalmologists the world over. In both trials, patients were randomized into 3 treatment groups to receive either: EYLEA HD every 12 weeks, EYLEA HD every 16 weeks, or EYLEA every 8 weeks. Two-year data from the pivotal PULSAR trial were originally presented at the EURETINA Congress in October 2023, and two-year data from the pivotal PHOTON trial were first presented at the American Society of Retina Specialists annual meeting in July 2023. In 2023, aflibercept 8 mg was launched as a new anti-VEGF drug following a phase 3 clinical trial, the PULSAR trial, with aflibercept 2 mg serving as the control drug . of aflibercept 8 mg in the pivotal phase 3 PULSAR trial. Martin Spitzer, 1. 9% of participants in the second year maintained Jul 29, 2023 · The two-year data from the pivotal PULSAR trial for aflibercept 8 mg in wet age-related macular degeneration (wAMD) are expected in the third quarter of 2023. Regeneron announced positive two-year (96 weeks) results from its PULSAR trial investigating Eylea ® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA ® (aflibercept, 2 mg) in patients with wet AMD. Methods : CANDELA was a single-masked, open-label, 44-week, phase 2 trial in which treatment-naïve patients with neovascular age-related macular degeneration (nAMD) were randomized 1:1 to receive 3 monthly doses of aflibercept 8 mg or 2 mg followed by doses at Weeks 20 and 32. Ursula Schmidt-Ott, 2 . Honorary Consul for Timor Leste, Hospitaller St. Almost 80% of patients with nAMD and nearly 90% of patients with DME were able to maintain a 16-week dosing regimen. Alyson Berliner, 4. Veeral S. The first-year results of the PULSAR trial demonstrated injections of aflibercept 8 mg every 12 or 16 weeks to be non-inferior to injections of aflibercept 2 mg every 8 weeks in Jul 29, 2023 · The PULSAR trial evaluated the efficacy and safety of intravitreal aflibercept 8 mg injection administrated every 12 or 16 weeks versus aflibercept 2mg every 8 weeks, each after 3 initial monthly injections in patients with treatment-naive nAMD. Oct 16, 2023 · Although the safety data in each individual clinical trial were similar between 8 mg and 2 mg aflibercept, pooling the analysis from the CANDELA, PHOTON, and PULSAR trials provides a much larger set of patients to compare the rate of adverse events between the two drug doses. 4% female) to receive aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or aflibercept 2 mg every 8 weeks. 263 mL, single-use vial: $1,250. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all Intravitreal Aflibercept 8 mg Injection in Patients With Neovascular Age- Related Macular Degeneration: 60-Week and 96-Week Results from the Phase 3 PULSAR Trial. Robert Vitti, 4. Chow , MD, FRCS(C) Intravitreal Aflibercept 8 mg in Patients With Polypoidal Choroidal Vasculopathy: Phase 3 PULSAR Trial Subgroup Analysis, David T. 5) 34 (2. The first-year results of the PULSAR trial demonstrated injections of aflibercept 8 mg every 12 or 16 weeks to be non-inferior to injections of aflibercept 2 mg every 8 weeks in Nov 24, 2023 · Rishi P. Mar 29, 2024 · PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. European Society of Retina Specialists (EURETINA) Congress, Amsterdam, The Netherlands, October 5– 8, 2023 Aug 10, 2023 · Aflibercept 8 mg clinical trial program According to the company’s news release, PULSAR in wAMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. University Retina and Macula Associate, Oak Forest, IL, USA. Eylea HD (aflibercept 8 mg) has been approved for use by the FDA in August 2023. Nov 5, 2022 · Ines Lains, MD Vitreoretinal Fellow Massachusetts Eye and Ear Infirmary. Sep 8, 2022 · The PHOTON trial in DME and the PULSAR trial in wAMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week Intravitreal Aflibercept 8 mg Injection in Patients with Neovascular Age- Related Macular Degeneration: 48-Week Results from the Phase 3 PULSAR Trial. Jean-François Korobelnik, Professor of Ophthalmology and the Head of the Department of Ophthalmology at the University Hospital of Bordeaux in France, presented the results of the PULSAR trial – a phase 3 active-controlled trial assessing the efficacy and safety of high dose aflibercept (8 mg) in Jan 16, 2024 · The principle finding of this phase 3 trial was that aflibercept 8 mg demonstrated similar improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST) compared to the 2 mg dose of aflibercept, through week 96 among treatment-naïve patients with neovascular AMD. 5 years, 54. 2 Investigators sought to determine the therapeutic benefit, injection interval, and safety of Sep 11, 2024 · The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at We would like to show you a description here but the site won’t allow us. Kimberly Reed, 4 . intravitreal aflibercept 8 mg maintained Q12 or Q16 week treatment intervals. The primary endpoint was at 1 year and included the option for a second-year extension. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if protocol-defined criteria Jun 27, 2023 · The two-year data from the pivotal PULSAR trial for aflibercept 8 mg in wet age-related macular degeneration are expected in the third quarter of 2023, and the two-year data from both PHOTON and PULSAR are planned for presentation at an upcoming medical meeting. 6 As with PHOTON, patients Dec 10, 2024 · BARCELONA, Spain — A post hoc analysis of PULSAR trial data showed sustained fluid control at 2 years with fewer injections and longer dosing intervals in patients treated with aflibercept 8 mg The results of the PULSAR trial support the noninferiority of aflibercept 8 mg every 12 weeks and aflibercept 8 mg every 16 weeks to aflibercept 2 mg every 8 weeks for the mean change from baseline in BCVA at week 48 in treatment-naive patients with nAMD when using a noninferiority margin of 4 letters in the FAS (high certainty). Apr 24, 2023 · Notable podium presentations will highlight the pivotal aflibercept 8 mg trials PULSAR and PHOTON, respectively, in wAMD and DME with 48-week efficacy and safety results, in addition to an evaluation of baseline characteristics of patients randomized to aflibercept 8 mg who maintained their dosing intervals and those whose dosing intervals were Sep 11, 2024 · A 96-week PULSAR Phase 3 trial post-hoc analysis: Rapid and sustained fluid control with aflibercept 8mg every 12 weeks or longer, as defined by fluid-free status at Weeks 16, 48, and 96 Aug 10, 2023 · "In the PULSAR trial, aflibercept 8 mg achieved impressive durability, while importantly maintaining visual acuity gains from year one through year two," trial investigator Charles Wykoff, M. Now, through 2 years of study, the vision gains were sustained and mainly remained consistent with the 1-year results. D. 3) PULSAR was a double-masked, 96-week, non-inferiority, phase 3 trial: patients with nAMD were randomized 1:1:1 to receive aflibercept 2 mg every 8 weeks, or 8 mg every 12 or 16 weeks after 3 monthly doses. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups. Purpose : To compare the safety of aflibercept 8 mg and 2 mg in the CANDELA, PHOTON, and PULSAR trials. In the combined aflibercept 8mg arm, 47% of patients who completed 96 weeks had dosing intervals of ≥20 weeks at week 96, and 28% had a 24-week dosing interval. on behalf of the Aug 31, 2024 · In PULSAR, aflibercept 8 mg demonstrated superior drying compared with aflibercept 2 mg at Week 16, a key secondary endpoint for the trial , as well as rapid fluid control, with a numerically aflibercept 8 mg • The incidence of non-ocular TEAEs, including serious TEAEs, APTC events, and deaths, was similar between aflibercept 8 mg and 2 mg • Overall, aflibercept 8 mg demonstrated similar safety to aflibercept 2 mg across the CANDELA, PULSAR, and PHOTON trials Feb 6, 2023 · Filing for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) is based on positive results of clinical trials, PULSAR and PHOTON / In both trials, aflibercept 8 mg demonstrated unprecedented durability results with treatment intervals of up to 16 weeks, with comparable visual acuity as Sep 11, 2024 · A 96-week PULSAR Phase 3 trial post-hoc analysis: Rapid and sustained fluid control with aflibercept 8mg every 12 weeks or longer, as defined by fluid-free status at Weeks 16, 48, and 96 stratified by baseline CRT and BCVA Oct 3, 2022 · Results from the pivotal PHOTON and PULSAR trials highlighted the success of 8-mg aflibercept every 12 or 16 weeks in patients with diabetic macular edema (DME) and neovascular age-related macular Apr 13, 2024 · Similar to PHOTON’s results, PULSAR demonstrated durable vision gains and reduction in central subfield thickness (CST) with 8-mg aflibercept at extended dosing intervals that are comparable to the 2-mg group (Figure 3), with 88 percent treated on ≥12-week dosing interval at the end of two years (Figure 4). rd. 1. Apr 17, 2023 · Notable podium presentations will highlight the pivotal aflibercept 8 mg trials PULSAR and PHOTON, respectively, in wAMD and DME with 48-week efficacy and safety results, in addition to an Aug 10, 2023 · PULSAR (N= 1,009) is a double-masked, active-controlled pivotal trial evaluating non-inferiority of aflibercept 8 mg 12-week (n=335) and 16-week (n=338) dosing regimens compared to an 8-week dosing regimen for EYLEA ® (aflibercept) Injection (n=336). Both the PULSAR trial in wAMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with EYLEA HD About the Aflibercept 8 mg Clinical Trial Program PULSAR in wAMD and PHOTON in DME are double-masked, active-controlled pivotal trials that are being conducted in multiple centers globally. 2,3 Aflibercept 8 mg, 30 mg per 0. PULSAR is the first randomised controlled phase 3 trial to directly compare aflibercept 8 mg and aflibercept 2 mg for the treatment . th. Mar 23, 2024 · Methods: PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. 8 (22. Both the PULSAR trial in wAMD (N=1,009) and PHOTON trial in DME (N=658) met their primary endpoint, with EYLEA HD demonstrating non-inferior and The PULSAR trial assessed the long-term effects of aflibercept 8 mg administered every 12 (8q12) or 16 weeks (8q16) compared to the standard 2 mg dose every 8 weeks (2q8) for nAMD. Mar 7, 2024 · EYLEA HD (aflibercept injection) is jointly developed by Bayer and Regeneron. 5, and +9. 9% and 47. Brown DM, PULSAR study investigators (2023) Aflibercept 8 mg in patients with nAMD: 48-week results from the phase 3 PULSAR trial. 7) 43 (3. 3 letters, respectively) At Week 16, fluid was absent in 67% and 63% of patients with PCV in the pooled aflibercept 8 mg group and aflibercept 2 mg group, respectively Aflibercept 8 mg and aflibercept 2 mg markedly reduced the proportion of patients with Apr 29, 2024 · Aflibercept 8 mg monotherapy shows maintained efficacy over 96 weeks, with the ability to extend dosing intervals beyond every 16 weeks, in patients with PCV in the PULSAR Phase 3 trial* #B0282 Oct 13, 2023 · Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. As previously announced, EYLEA HD demonstrated durable vision Sep 12, 2024 · The phase III PULSAR trial in nAMD and phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) at During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing Sep 28, 2020 · Participants will receive aflibercept 2 mg every 8 weeks, aflibercept 8 mg every 12 weeks or aflibercept 8 mg every 16 weeks, after 3 initial injections at 4-week intervals. “Less than a year after its approval aflibercept 2 mg is hypothesized to provide longer effective vitreal concentrations and enable a more sustained effect on VEGF signaling Here, we present the results of the ongoing, randomized, double-masked, 96-week, Phase 3 PULSAR trial in patients with treatment-naïve nAMD PIEGF„ VEGE uls Aug 10, 2023 · “In the PULSAR trial, aflibercept 8 mg achieved impressive durability, while importantly maintaining visual acuity gains from year 1 through year 2. Andrea Schulze, 2. Sheth, 1. Stewart,1 Paolo Lanzetta,2 Jean-François Korobelnik,3 Tobias Machewitz,4 Jan 25, 2024 · At week 48 in the PULSAR clinical trial, aflibercept 8 mg, dosed with extended treatment intervals (every 12 or every 16 weeks) demonstrated comparable visual acuity to the standard of care Eylea (aflibercept 2 mg) with a fixed 8-week treatment interval, following three initial monthly doses. Sep 11, 2024 · A 96-week PULSAR Phase 3 trial post-hoc analysis: Rapid and sustained fluid control with aflibercept 8mg every 12 weeks or longer, as defined by fluid-free status at Weeks 16, 48, and 96 In phase 3 clinical trials for faricimab, aflibercept in the second year was administered at 8-week intervals, while integrated post hoc analysis of VIEW 1 and VIEW 2 trials showed that, among patients receiving aflibercept every four weeks and eight weeks in the first year, 53. The anatomic and visual benefits of aflibercept, 8 mg, observed in the CANDELA trial are supported by recently released 48-week primary end point data from the ongoing phase 3 PULSAR trial in nAMD, which showed participants receiving aflibercept, 8 mg, every 12 or 16 weeks following 3 initial monthly injections achieved noninferior visual gains Sep 8, 2022 · The PHOTON trial in DME and the PULSAR trial in wAMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen. Aug 10, 2023 · Last year, the PULSAR trial met its primary endpoint with patients treated with aflibercept 8 mg achieving clinically equivalent vision gains to aflibercept. Oct 18, 2024 · PULSAR in wet age-related macular degeneration and PHOTON in DME/diabetic retinopathy (DR) are double-masked, active-controlled pivotal trials that were conducted in multiple centers globally. PULSAR Trial. About PULSAR and PHOTON PULSAR and PHOTON are randomized, double-masked, active-controlled pivotal trials. Patients were randomly assigned 1:1:1 to receive aflibercept 8 mg every 12 or 16 weeks (8q12 [n=335] or 8q16 [n=338]) or aflibercept 2 mg every 8 weeks (2q8 [n=336]), each after three initial monthly injections. Jean-François Korobelnik, 2. --Regeneron Pharmaceuticals, Inc. To date, Eylea™ 8 mg (aflibercept 8 mg, 114. Paolo Lanzetta, 1. Mar 23, 2024 · PULSAR is the first randomised controlled phase 3 trial to directly compare aflibercept 8 mg and aflibercept 2 mg for the treatment of nAMD. Early Fluid Resolution Association With Treatment Interval Maintenance at Week 48 in Patients Receiving Aflibercept 8 mg: Phase 3 PULSAR Trial* PO474 ePoster. Rationale for the Recommendation. In both trials, patients were randomized into 3 treatment groups to receive either: aflibercept 8 mg every 12 weeks Intravitreal Aflibercept 8 mg Injection in Patients With Neovascular Age- Related Macular Degeneration: 60-Week and 96-Week Results from the Phase 3 PULSAR Trial. Aflibercept 8 mg is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority. ilwbf wfhlrs xdk qde llgeni urhfk pkljpof ctiap ljh kkvbt