DEXAspheres (dexamethasone microspheres) / Regeneron - LARVOL DELTA

Mechanistic understanding of LAI suspension intramuscular depot formation: A physicochemical perspective. (PubMed, J Control Release) - "The present study provides a mechanistic understanding of intramuscular depot formation and drug release of Depo-Provera® (medroxyprogesterone acetate) injectable suspension and its qualitatively and quantitatively (Q1/Q2) equivalent formulations from a physicochemical perspective...Co-administration of dexamethasone microspheres markedly attenuated inflammation and reduced CD68-positive cell density across the formulations. However, no clear correlation was observed between particle size and in vivo drug release under the study conditions, potentially due to confounding factors affecting systemic clearance. Instead, a potential association was identified between depot structure, local immune response, and drug release kinetics, highlighting depot morphology and tissue interactions as key determinants of the in vivo performance."

Journal • Inflammation • CD68

Evaluating Bella-Vue and novel Faros microspheres for high-concentration suprachoroidal injection (ARVO 2026) - "The injectability of Frenelle Pharma's Faros™ 90-day dexamethasone microspheres (SX600) was assessed using standard 30G 0.5-inch needles and Bella-Vue...Conclusions Bella-Vue supported reliable suprachoroidal delivery in an ex vivo model and demonstrated superior in vitro injectability with Faros microspheres compared to conventional 30 µm PLGA suspensions. Broad syringe compatibility with quantified dead volume and small dosing error supports Bella-Vue as an enabling platform for suprachoroidal delivery of long-acting microsphere therapeutics."

Ophthalmology

OXEYE: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=3 | Completed | Sponsor: Oxular Limited | Active, not recruiting ➔ Completed

Trial completion • Diabetic Macular Edema • Ophthalmology

3D-printed scaffolds: Incorporating dexamethasone microspheres and BMP2 for enhanced osteogenic differentiation of human mesenchymal stem cells. (PubMed, Colloids Surf B Biointerfaces) - "Calcium deposition and elemental analysis also demonstrated enhanced mineralization in the Dex-M+BMP2 +G-scaffold group, with calcium and phosphate levels 3.9-1.7 times higher than in the other groups. Overall, the Dex-M+BMP2 +G-scaffold effectively promoted osteogenic differentiation and mineralization of hMSCs, underscoring its potential as a promising biomaterial for bone tissue engineering applications."

Journal • BMP2

OXEYE: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=3 | Active, not recruiting | Sponsor: Oxular Limited | Recruiting ➔ Active, not recruiting | N=128 ➔ 3 | Trial primary completion date: Sep 2024 ➔ Nov 2024

Enrollment change • Enrollment closed • Trial primary completion date • Diabetic Macular Edema • Ophthalmology

OXEYE: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=128 | Recruiting | Sponsor: Oxular Limited | Not yet recruiting ➔ Recruiting | Initiation date: Mar 2023 ➔ Jul 2023

Enrollment open • Trial initiation date • Diabetic Macular Edema • Ophthalmology

OXEYE: Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Oxular Limited

New P2 trial • Diabetic Macular Edema • Ophthalmology