Clearside Biomedical announces multiple presentations at ASRS Annual Meeting
Clearside Biomedical announced that multiple oral presentations were delivered on Clearside's pipeline and proprietary SCS Microinjector targeting the suprachoroidal space. Presentations: Title: Suprachoroidal administration of DNA nanoparticles transfect chorioretinal cells in primates and rabbits: Dr. Kay recorded a video presentation describing the preclinical studies for the use of gene therapy via suprachoroidal injection. The presentation is available as a Paper-On-Demand. In the studies, a luciferase assay was used to study gene expression in the animal models via suprachoroidal administration of DNA nanoparticles. Luciferase activity was observed in the retina and retinal pigment epithelial and choroid of all eyes that received suprachoroidal injection of DNPs. In rabbits, suprachoroidal injection of luciferase DNPs produced activity comparable to that seen from subretinal injections of luciferase DNPs. SCS injections of DNPs were generally well-tolerated across both rabbits and non-human primates, and no significant abnormalities were observed on ophthalmic exams. SCS injections of DNPs may offer the potential for a safe and efficient delivery method, and may address an unmet need in ocular gene delivery. Title: Clinical Experience with the SCS Microinjector for Suprachoroidal Injections by Ophthalmologists: Dr. Shah's presentation described the clinical experience using the SCS Microinjector for suprachoroidal injection of XIPERE. His methods included a physician survey of injection experience, and a post-hoc analysis of two Clearside clinical trials for non-infectious uveitis. Injection survey results revealed little difficulty in following the steps in the procedure and generally no challenges compared to other types of injections. In the post-hoc analysis, the majority of injections were completed with the 900microm needle, and 83% of injections used the same needle length for a patient's two injections. In summary, by utilizing the proper techniques, SCS injections can be easily conducted in a physician's office as a potentially useful targeted delivery of drug to posterior segment pathologies. Title: Suprachoroidal CLS-TA Improves Patient Outcomes in Uveitis of All Anatomic Subtypes: Results of the Phase 3 PEACHTREE Study: In the trial, the distribution of each uveitis anatomic subtype was similar in both the treatment arm and the control arm. Subgroup analyses were performed to evaluate outcomes based on anatomic subtype of uveitis. In the CLS-TA treatment arm, patients all had statistically significant visual acuity gains compared to the sham arm: anterior - 14.4 letters, intermediate - 13.4 letters, posterior - 15.6 letters, panuveitis -12.0 letters. In the CLS-TA treatment arm, patients also all had statistically significant reductions in macular thickness compared to the sham arm at week 24: anterior - 106 microns at week 24, intermediate - 155 microns, posterior- 154 microns, panuveitis - 164 microns. Title: Suprachoroidally Injected CLS-TA in Uveitis Maintains Efficacy Outcomes Through 48 Weeks: Results of the MAGNOLIA Phase 3 Extension Study: In the trial, 50% of patients did not receive additional medication through week 48, which corresponded to 36 weeks after their second of two quarterly, protocol-mandated injections of XIPERE. Suprachoroidally injected XIPERE significantly improved vision and macular edema in MAGNOLIA. There were no serious adverse events related to study medication, and elevations in intraocular pressure were low in number and consistent with those seen in the PEACHTREE trial. Title: Suprachoroidal CLS-TA Plus Aflibercept Compared with Aflibercept Monotherapy for Diabetic Macular Edema: Results of a Phase 2 Trial: The trial demonstrated similar best corrected visual acuity improvements with combination aflibercept and CLS-TA treatment compared to aflibercept monotherapy. Central subfield thickness improvement was significantly greater with combination treatment vs aflibercept monotherapy. Other anatomic outcomes such as diabetic retinopathy severity score and changes in disorganization of the retinal inner layers were similar in both arms. Meaningfully, fewer treatment visits were needed in the combination arm compared to aflibercept monotherapy: 4.7 versus 2.8 mean treatment visits, suggesting the potential to address treatment burden. There were no SAEs assessed as related to study drug or study procedure in either arm.