Levosulpiride Shows Potential of Treating Diabetic Eye Conditions

A recent study published in the Eye Journal that the prokinetic drug levosulpiride may hold significant promise in the treatment of diabetic eye conditions, particularly center-involving Diabetic Macular Edema (DME). The study, a prospective, randomized, double-blinded, dual-center phase 2 trial, demonstrated that levosulpiride improved both visual and structural outcomes in patients with DME.

Diabetic retinopathy, a common complication of diabetes, can lead to severe vision impairment or blindness. One of its variants, proliferative diabetic retinopathy (PDR), is characterized by abnormal blood vessel growth and increased vascular permeability in the retina. Vasoinhibin, a molecule with anti-vasopermeability and anti-angiogenic properties, has shown promise in treating these conditions. This study aimed to explore the potential of levosulpiride in elevating vasoinhibin levels and its subsequent clinical benefits.

The study involved two groups: one with patients suffering from center-involving DME and another with PDR patients undergoing elective pars plana vitrectomy. In both groups, half of the participants received levosulpiride orally, while the other half received a placebo.

The results were striking. Patients treated with levosulpiride for eight weeks exhibited significant improvements in various key parameters compared to those on a placebo. Best-corrected visual acuity, central foveal thickness, and mean macular volume all showed statistically significant improvements at weeks 4, 6, and 8.

At the 8-week mark, patients in the levosulpiride group also experienced a higher proportion of positive outcomes. This included a greater number of patients gaining at least 5 ETDRS letters at 4 meters, losing more than 21 micrometers in central foveal thickness, and experiencing a reduction of more than 0.06 cubic millimeters in mean macular volume, all of which are crucial indicators of improved vision.

Additionally, the study found that levosulpiride reduced levels of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF) in the vitreous of PDR patients, which are known to play key roles in the development and progression of diabetic eye diseases.

Importantly, no significant adverse side-effects were detected during the study, suggesting that oral levosulpiride is well-tolerated in these patient populations.

These findings indicate that levosulpiride may work by upregulating vasoinhibin and downregulating VEGF and PlGF within the eye, potentially offering an effective therapeutic option for patients with center-involving DME. However, further research through larger clinical trials is needed to assess the long-term efficacy and safety of this treatment. Nevertheless, this study marks a significant step forward in the fight against diabetic eye conditions and raises hope for improved vision and quality of life for millions of affected individuals worldwide.

Source:

Núñez-Amaro, C. D., López, M., Adán-Castro, E., Robles-Osorio, Ma. L., García-Franco, R., García-Roa, M., Villalpando-Gómez, Y., Ramírez-Neria, P., Pineiro, N., López-Star, E., Bertsch, T., Marínez de la Escalera, G., Triebel, J., & Clapp, C. (2023). Levosulpiride for the treatment of diabetic macular oedema: a phase 2 randomized clinical trial. In Eye. Springer Science and Business Media LLC. https://doi.org/10.1038/s41433-023-02715-5