Loading...
  • Phase
  • AAVL ) today announced that its Phase 2a clinical study for AVA-101 met its 12-month primary endpoint, based on ophthalmic and systemic safety, demonstrating that AVA-101 was well tolerated with a favorable safety profile in subjects with wet age-related macular degeneration (wet AMD). (marketwired.com)
  • The results of this study confirm the Phase 1 safety results and suggest that AVA-101 could potentially benefit a significant portion of patients with wet AMD who require regular treatment with anti-VEGF therapy," said Samuel B. Barone, M.D., Avalanche's chief medical officer. (marketwired.com)
  • The Phase 2a study enrolled 32 subjects age 55 or older with wet AMD and randomized them to an AVA-101 treatment group (n=21) or a control group (n=11). (marketwired.com)
  • OTCQX: RHHBY), today announced positive, top line results from the Phase II LADDER study evaluating the efficacy and safety of its investigational Port Delivery System with ranibizumab (PDS) in people with wet age-related macular degeneration (AMD), a leading cause of blindness for people age 60 and over, in the United States. (drugs.com)
  • 3,4 "LADDER is the first successful Phase II study of a long-acting delivery device for the treatment of wet AMD. (drugs.com)
  • The results from this study will help determine the most appropriate dose and fixed treatment interval to study in the Phase III program to sustain optimal vision outcomes in clinical practice for patients with wet AMD. (drugs.com)
  • The Complaint alleges that throughout the Class Period, the Defendants made materially false and/or misleading statements and failed to disclose that Phase 2a of the AVA-101 study was not designed to show any statistical significance between the active and control groups in the secondary endpoints. (marketwired.com)
  • After the market closed on June 15, 2015, the Company issued a press release entitled, "Avalanche Biotechnologies, Inc. Announces Positive Top-Line Phase 2a Results for AVA-101 in Wet Age-Related Macular Degeneration. (marketwired.com)
  • Avalanche said that the company's treatment for wet age-related macular degeneration met its primary endpoint, however, in a conference call to discuss Phase 2 clinical trial results, the company indicated that the study wasn't designed to show statistically significant differences between active and control groups. (marketwired.com)
  • atrophy
  • The right side shows a PED with some subretinal hemorrhage around it on the edge of a very significant vertical macular scar with atrophy and hyperpigmentation anterior to it extending into the temporal periphery. (retinagallery.com)
  • fluid
  • Distorted vision where straight lines appear curved is usually due to fluid accumulating from Wet AMD, although sometimes the drusen found in Dry AMD may cause this symptom. (retinaspecialty.com)
  • Therapy
  • AVA-101 is being developed as a sub-retinal gene therapy injection to provide a safe and effective treatment for wet AMD that is durable and reduces the need for frequent anti-VEGF injections. (marketwired.com)
  • AVA-101 demonstrated tolerability and a promising treatment effect in the subjects treated in this study, many of whom had been extensively treated with anti-VEGF therapy prior to enrollment and showed difficult-to-treat characteristics including persistent recurrent wet AMD activity," said Thomas W. Chalberg, Jr., Ph.D., Avalanche's co-founder and chief executive officer. (marketwired.com)
  • There are several treatments available for wet macular degeneration including photodynamic therapy, laser photocoagulation, and medications that can be injected into the eye. (hubpages.com)
  • Pazopanib , an investigational topical therapy for wet macular degeneration, shows positive beneficial results in clinical studies, Says Dr. Ilan Cohen , a New York City Ophthalmologist. (wordpress.com)
  • The current standard of care for wet AMD can be burdensome because it requires patients to visit their ophthalmologist as often as monthly for eye injections of anti-vascular endothelial growth factor (VEGF) therapy to help maintain vision gains and/or prevent vision loss. (drugs.com)
  • This high treatment burden with anti-VEGF therapy can lead to under-treatment of wet AMD and, potentially, less than optimal vision outcomes. (drugs.com)
  • In 1995 the era of highly active anti-retroviral therapy (HAART) was initiated by the United States FDA's approval of Hoffman LaRoche's HIV protease inhibitor saquinavir. (wikipedia.org)
  • injections
  • As elders shudder at monthly injections to the eye and its side effects, the process of bringing pazopanib eye drops for wet AMD to the clinics shall be made with incredible speed. (wordpress.com)
  • several
  • Variations in several genes, particularly in the complement system, increase the risk of developing GA. This is an active area of research but the current hypothesis is that with aging, damage caused by these stressors accumulates, which coupled with a genetic predisposition, results in the appearance of drusen and lipofuscin deposits (early and intermediate AMD). (wikipedia.org)
  • Damage
  • Variations in several genes, particularly in the complement system, increase the risk of developing GA. This is an active area of research but the current hypothesis is that with aging, damage caused by these stressors accumulates, which coupled with a genetic predisposition, results in the appearance of drusen and lipofuscin deposits (early and intermediate AMD). (wikipedia.org)
  • therapy
  • In 1995 the era of highly active anti-retroviral therapy (HAART) was initiated by the United States FDA's approval of Hoffman LaRoche's HIV protease inhibitor saquinavir. (wikipedia.org)
  • areas
  • Normally, oxygen would bind to hemoglobin in the lungs and be released in areas with low oxygen partial pressure (e.g. active muscles). (wikipedia.org)
  • research
  • Additionally, Fight for Sight has increased their AMD research effort by forming Action Against AMD in collaboration with Blind Veterans, Macular Society and Scottish War Blinded. (fightforsight.org.uk)