Novartis Announces Positive Phase 3 Results for Brolucizumab in Proliferative Diabetic Retinopathy, Demonstrating Superior Vision Maintenance and Potential for Dosing Every Six Months

May 09, 2024 14:12 CST Updated 14:13

Novartis

Drug Development and Manufacturing

▎Edited by the WuXi AppTec content team

Today (May 9),（Novartis）Announced the first presentation of Brolucizumab at the Association for Research in Vision and Ophthalmology (ARVO) conference.brolucizumab) 6mg TreatmentProliferative Diabetic Retinopathy (PDR)The 54-week results of the Phase 3 CONDOR clinical study.

According to the press release, the trial is a global Phase 3 registration study that includes a Chinese participant population.Study Confirms the Efficacy of Brolucizumab in PDR PatientsMaintain VisionSignificantly superior to traditional therapies, itsCanRollbackDiabetic Retinopathy,The proportion of patients without PDR at Week 54 was in the control group.Nearly three times (63.8% vs 22.4%).In terms of administration, patients may extend the treatment interval of Brolucizumab based on disease activity assessment after 48 weeks.Extended by 6 weeks each time, up to a maximum of 24 weeks.

Diabetic retinopathy is the leading cause of irreversible vision loss in the working population.PDR is the advanced stage of diabetic retinopathy.Marked by abnormal neovascularization in the retina, it can lead to complications such as vitreous hemorrhage, tractional retinal detachment, and neovascular glaucoma, posing a serious threat to the patient's visual function.Panretinal photocoagulation (PRP) is the standard treatment for PDR, and the mainstream view holds that lasers work through thermal effects.Destroy retinal capillary non-perfusion areas, reduce tissue oxygen demand, and decrease VEGF production to slow disease progression.Moreover, anti-VEGF drugs can directly block the VEGF signaling pathway in terms of mechanism, and clinical studies have also shown that anti-VEGF treatment is effective in improving the condition of patients with PDR.

Brolucizumab was developed by Novartis.Full VEGF-A InhibitorIt is a novel humanized single-chain antibody fragment with a molecular weight of only 26kDa, high affinity, strong tissue penetration, and minimal systemic side effects. This drug has already been approved in over 70 countries worldwide for the treatment of nAMD (neovascular age-related macular degeneration) and DME (diabetic macular edema). The drug was previously submitted for marketing approval in China in August 2023.

CONDOR Study is a randomized, two-arm, single-blind, positive-controlled Phase 3 clinical study lasting 96 weeks, designed to compare the efficacy and safety of Brolucizumab 6mg versus traditional PRP therapy in treating PDR.In the study, 347 and 342 subjects were enrolled in the brolucizumab group and the PRP group (1:1), respectively, with a total of 572 subjects completing the 54-week follow-up.The primary endpoint of the study is the best-corrected visual acuity from baseline to Week 54 (BCVA）Changes.

In the study, participants in the brolucizumab groupLoading period receiving every 6 weeks (q6w)Treated with Debuxizumab, for a total of 3 times;During the maintenance period, the treatment interval was extended to every 12 weeks (q12w).，The treatment interval may be extended (by 6 weeks each time) based on disease activity assessment after 48 weeks, with a maximum extension of up to 24 weeks.If the condition worsens during the maintenance period, the treatment interval will be shortened again to every 6 weeks (q6w). Participants in the PRP group received 1 to 4 initial PRP treatments within 12 weeks, followed by supplemental treatments as needed.

Week 54 results showed that the change in BCVA from baseline was better in the brolucizumab group than in the PRP group.(0.2 vs -4.2 ETDRS letters)；
Brolucizumab treatment can regress diabetic retinopathy,At week 54, the proportion of patients without PDR in the brolucizumab group was significantly higher than that in the PRP group, nearly three times as much (63.8% vs 22.4%).；
At week 54, the proportion of patients with a ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score was significantly higher in the brolucizumab group than in the PRP group.（45.2% vs 20.4%）；
Brolucizumab can also reduce the risk of complications associated with diabetic retinopathy. The proportion of patients in the brolucizumab group with at least one episode of center-involved diabetic macular edema (CI-DME) by week 54.（31.1% vs 72.7%）And Vision-Threatening Complications（33.7% vs 75.7%）The incidence was significantly lower than that in the PRP group.
In the study, no additional safety risks were found with brolucizumab in the PDR population.

The study results indicate that brolucizumab is superior to traditional panretinal photocoagulation in maintaining vision, controlling the progression of diabetic retinopathy, and reducing central-involved macular edema.

References:

[1] ARVO Heavyweight Release - Brolucizumab PDR Global Phase III Trial Results: Significant Superiority in Vision Maintenance Compared to Conventional PRP Therapy. Retrieved May 9, 2024, from https://mp.weixin.qq.com/s/MOlJqU43s_fgQ-1HTBCDHg

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