Novartis Announces Positive Phase III CONDOR Trial Results for Brolucizumab in Proliferative Diabetic Retinopathy

May 10, 2024 10:23 CST Updated 10:23

Novartis

Drug Development and Manufacturing

On May 9, Novartis Group's official WeChat account announced that it had for the first time disclosed the 54-week results of the Phase III clinical trial (CONDOR study) of brolucizumab 6mg in treating proliferative diabetic retinopathy (PDR) at the 2024 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO).

This trial is the first global Phase III registration study of PDR involving the Chinese population, aiming to compare the efficacy and safety of Brolucizumab and panretinal photocoagulation (PRP) in treating PDR.

The study confirmed,Brolucizumab demonstrates significantly superior vision maintenance in PDR patients compared to traditional PRP therapy, achieving remarkable results:

The 54-week results of the CONDOR study showed that brolucizumab was significantly superior to PRP in maintaining the best-corrected visual acuity (BCVA) in patients with PDR (0.2 vs -4.2 ETDRS letters, p<0.001).
Compared with PRP, the proportion of patients without PDR in the brolucizumab treatment group was nearly three times that of the PRP group at week 54 (63.8% vs 22.4%, p<0.001), and more patients achieved a ≥2-step improvement in DRSS (Diabetic Retinopathy Severity Scale) score (45.2% vs 20.4%, p<0.001).
At week 54, the proportion of patients treated with brolucizumab who experienced at least one CI-DME (center-involved diabetic macular edema) event was significantly lower than in the PRP group (31.1% vs 72.7%, p<0.001).
In the study, brolucizumab did not show additional safety issues in the PDR population.

The 2024 Annual Meeting of the "Association for Research in Vision and Ophthalmology" (ARVO) was held as scheduled from May 5 to May 9, 2024, in Seattle, USA. At the meeting, Novartis announced for the first time the pre-specified 54-week analysis results of the CONDOR study—a Phase III clinical trial of brolucizumab 6mg for the treatment of proliferative diabetic retinopathy (PDR).^[1]。

CONDOR Study is the world's first global Phase III registration study involving the Chinese population for PDR. The results show that Brolucizumab is superior to Panretinal Photocoagulation (PRP) in maintaining vision, controlling DR progression, and reducing center-involved diabetic macular edema (CI-DME).

The primary endpoint of the CONDOR study is the change in best-corrected visual acuity (BCVA) from baseline to Week 54.

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, p<0.001, Figure 1).

Change in BCVA Mean from Baseline

BCVA, Best Corrected Visual Acuity; BRO, Brolucizumab; PRP, Panretinal Photocoagulation; SE, Standard Error

Image Source: ARVO

Brolucizumab treatment can regress diabetic retinopathy (DR). At week 54, the proportion of patients without PDR in the brolucizumab group was significantly higher than that in the PRP group (63.8% vs 22.4%, p<0.001, Figure 2).

Study on the Proportion of Patients Without PDR in the Eye

BRO, Brolucizumab; PDR, Proliferative Diabetic Retinopathy; PRP, Panretinal Photocoagulation

Image Source: ARVO

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%, p<0.001).

Brolucizumab can also reduce the risk of DR-related complications. At 54 weeks, the proportion of patients with at least one CI-DME event involving the macular center in the brolucizumab group (31.1% vs 72.7%, p<0.001) and the incidence of vision-threatening complications (33.7% vs 75.7%, p<0.001) were significantly lower than those in the PRP group.

In the study, no additional safety risks were found with brolucizumab in the PDR population.

References:

1.Yongsoo K et al. Brolucizumab for the treatment of proliferative diabetic retinopathy: 54-week results from the CONDOR study. Presented at: The Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting. May 2024.

2.Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36.

3.Sun JK, Glassman AR, Beaulieu WT, Stockdale CR, Bressler NM, Flaxel C, Gross JG, Shami M, Jampol LM; Diabetic Retinopathy Clinical Research Network. Rationale and Application of the Protocol S Anti-Vascular Endothelial Growth Factor Algorithm for Proliferative Diabetic Retinopathy. Ophthalmology. 2019 Jan;126(1):87-95.

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