{"id":20386,"date":"2025-01-01T10:54:13","date_gmt":"2025-01-01T02:54:13","guid":{"rendered":"https:\/\/flcube.com\/?p=20386"},"modified":"2025-01-01T10:54:15","modified_gmt":"2025-01-01T02:54:15","slug":"frontera-therapeutics-advances-to-phase-ii-with-ft-003-for-diabetic-macular-edema","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=20386","title":{"rendered":"Frontera Therapeutics Advances to Phase II with FT-003 for Diabetic Macular Edema"},"content":{"rendered":"\n<p>Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). This follows previous clearance for a Phase II study in neovascular age-related macular degeneration (nAMD) in the United States.<\/p>\n\n\n\n<p><strong>Preclinical Data and Therapeutic Potential of FT-003<\/strong><br>Preclinical data indicates that FT-003 can efficiently transfect multiple layers of retinal cells upon injection into the fundus, leading these cells to express and secrete anti-VEGF proteins. This action inhibits endothelial cell division and proliferation, reduces vascular permeability, and offers comprehensive therapeutic functions. The gene therapy is anticipated to provide long-term effectiveness for patients with nAMD and DME through a single injection.<\/p>\n\n\n\n<p><strong>Clinical Studies in China and Positive Phase I Results<\/strong><br>In China, clinical studies for FT-003 in both nAMD and DME have begun enrolling subjects. Encouraging results from Phase I trials have shown significant improvements in visual acuity and retinal structure for patients with nAMD and DME after intravitreal injection of FT-003. Moreover, the demand for anti-VEGF treatment decreased by more than 80%, significantly reducing the treatment burden for patients suffering from these conditions.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US&#8230;<\/p>\n","protected":false},"author":1,"featured_media":20388,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[62,144,44],"class_list":["post-20386","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-clinical-trial-approval-initiation","tag-frontera-therapeutics","tag-ophthalmology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Frontera Therapeutics Advances to Phase II with FT-003 for Diabetic Macular Edema - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Sino-US firm Frontera Therapeutics, Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II study assessing its recombinant adeno-associated virus (rAAV) gene therapy, FT-003, in patients with diabetic macular edema (DME). 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