Patients in the combination arm gained an average of 12.3 letters, compared with 13.5 letters in the control arm.
#Bear tracks retina treatment trial
The trial met its primary endpoint, mean improvement in BCVA from baseline at 6 months on the ETDRS scale. Patients in either arm could receive intravitreal aflibercept treatment at months 4 and 5 as needed.
#Bear tracks retina treatment plus
The patients were randomly assigned 1:1 to receive either quarterly treatment with suprachoroidal CLS-TA together with intravitreal aflibercept (the combination arm) or four monthly treatments of intravitreal aflibercept plus a sham suprachoroidal procedure (the control arm). This multicenter, randomized, masked, controlled phase 2 trial enrolled 71 patients who were naïve to treatment for DME. Clearside Biomedical announced positive top line results from its phase 2 clinical trial TYBEE, evaluating suprachoroidal CLS-TA in combination with intravitreal aflibercept in patients with DME over a 6-month period.This construct, when tested in a naturally occurring canine disease model of RHO-adRP by investigators at the University of Pennsylvania, resulted in complete suppression of the endogenous RHO RNA while the human RHO replacement transgene produced up to 30% of normal RHO protein levels. The RHO-adRP product candidate combines, in a single AAV2/5 vector, a transgene expressing a highly efficient novel short-hairpin RNA designed to target and knock down endogenous rhodopsin (RHO) in a mutation-independent manner plus a human RHO replacement transgene made resistant to RNA interference. Proof-of-concept study results were published for an adeno-associated virus (AAV) gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant RP (RHO-adRP), licensed by Ophthotech.A fourth extension cohort will then receive the highest tolerated dose. Study participants will receive increasing doses of GS030-DP in a single intravitreal injection in their worse affected eye.
GS030 is the combination of a gene therapy (GS030-DP), administered via a single intravitreal injection, and a wearable optronic visual stimulation device (GS030 MD). PIONEER is a first-in-man, multicenter, open-label, dose-escalation study to evaluate the safety and tolerability of GS030 in patients with RP. GenSight Biologics received approval from the UK Medicines and Healthcare Regulatory Agency to initiate the PIONEER phase 1/2 study of GS030 in patients with RP.In August, the FDA approved 12-week dosing for aflibercept ( Eylea, Regeneron) based on 2-year data from the phase 3 VIEW 1 and 2 trials, in which patients with wet age-related macular degeneration (AMD) were treated with a modified 12-week dosing schedule with additional doses as needed.The agency will seek to improve the efficiency of the processes for development and approval of biosimilars and interchangeable products. FDA commissioner Scott Gotlieb explained that the Biosimilars Action Plan will use the agency’s experience with generic drugs to promote competition among biosimilars. In July, the FDA released plans to facilitate the development, approval, and market entry of biosimilars in the United States.The FDA’s fast track process is designed to expedite the development and review of drugs intended to treat serious conditions and fill unmet medical needs. MeriaGTx is conducting an open-label, phase 1/2 dose escalation clinical trial of AAV-RPGR in adult and pediatric patients diagnosed with XLRP. In April, the FDA granted fast track designation for AAV-RPGR ( MeiraGTx), for the treatment of X-linked retinitis pigmentosa (XLRP) due to defects in the retinitis pigmentosa (RP) GTPase regulator gene.Quantel Medical introduced the Vitra 2 retinal photocoagulator. LumiThera debuted the Valeda Light Delivery System for the treatment of dry AMD.Īn OCT angiography module for the Spectralis imaging platform (Heidelberg Engineering) is now available in the United States. Optikon introduced R-Evo Smart for cataract and retinal surgeries.
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