{"id":42873,"date":"2026-07-23T01:37:00","date_gmt":"2026-07-22T23:37:00","guid":{"rendered":"http:\/\/stocks-future.com\/?guid=174f04a49cc281c5e07cb108917f4ad1"},"modified":"2026-07-23T01:37:00","modified_gmt":"2026-07-22T23:37:00","slug":"iveena-delivery-systems-announces-positive-end-of-phase-1-fda-meeting-for-ivmed-85","status":"publish","type":"post","link":"https:\/\/stocks-future.com\/?p=42873","title":{"rendered":"iVeena Delivery Systems Announces Positive End-of-Phase 1 FDA Meeting for IVMED-85"},"content":{"rendered":"

\nFDA supports advancement of IVMED-85 into Phase 2 clinical development for pediatric myopia and provides alignment on key elements of the development program<\/i><\/p><\/a><\/a>

SALT LAKE CITY--(BUSINESS WIRE)--iVeena Delivery Systems, Inc., \u201ciVeena\u201d a clinical-stage ophthalmic pharmaceutical company developing innovative therapies for eye diseases, today announced a successful End-of-Phase 1 Type B meeting with the U.S. Food and Drug Administration (FDA) for IVMED-85, an investigational, non-atropine eye drop being developed for the treatment of pediatric myopia.<\/p>

\nThe meeting followed the recently announced successful completion of iVeena's Phase 1 clinical study evaluating the safety and tolerability of IVMED-85 in healthy adult volunteers. During the meeting, the FDA confirmed that the Phase 1 clinical data, together with the Company's previously completed nonclinical toxicology program, support advancement into pediatric Phase 2 clinical development.<\/p>

\nThe FDA also provided constructive feedback and alignment on key aspects of the Company's proposed Phase 2 clinical development program, including study design, efficacy endpoints, statistical analysis, and overall development strategy. The meeting provides iVeena with a clear regulatory framework as it finalizes its Phase 2 protocol and advances IVMED-85 through clinical development.<\/p>

\n\"We are very pleased with the outcome of this important regulatory milestone,\" said Michael Burr, Chief Operating Officer of iVeena. \"The FDA's feedback provides a clear path forward for our pediatric Phase 2 study and reflects the productive collaboration we've had with the Agency throughout development. We appreciate the thoughtful guidance received during the meeting and look forward to advancing IVMED-85 into the next stage of clinical development.\"<\/p>

\nBased on the feedback from the FDA, iVeena will finalize the Phase 2 protocol. When submitted under an active IND protocol are subject to the FDA's standard 30-day review process before patient enrollment. iVeena also discussed longer-term development plans during the meeting, including considerations for pivotal Phase 3 studies. The FDA provided valuable feedback that will help optimize iVeena's overall clinical development strategy as the program progresses.<\/p>

\nAbout IVMED-85<\/b><\/p>

\nLead program IVMED-85 is a new chemical entity (NCE), preservative-free prescription eye drop to prevent myopic progression. IVMED-85 is a non-surgical, non-invasive, non-atropine daily eye drop that strengthens scleral and corneal collagen crosslinks through LOX activation, potentially leading to improved refraction and a decrease in the rate of axial elongation.<\/p>

\nIVMED-85 has successfully completed a randomized, double-masked, vehicle-controlled Phase 1 clinical study demonstrating a favorable safety and tolerability profile in healthy adult volunteers and is being advanced into Phase 2 clinical development in a pediatric population.<\/p>

\nAbout iVeena<\/b><\/p>

\niVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena previously licensed to Glaukos, Inc, lead asset, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first-in-class, investigational eye drop formulation for pediatric myopia.<\/p> Contacts<\/b>

\niVeena Delivery Systems, Inc.\nEmail: press@iveenamed.com<\/a><\/p>","protected":false},"excerpt":{"rendered":"

FDA supports advancement of IVMED-85 into Phase 2 clinical development for pediatric myopia and provides alignment on key elements of the development programSALT LAKE CITY–(BUSINESS WIRE)–iVeena Delivery Systems, Inc., \u201ciVeena\u201d a clinical-stage opht…<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-42873","post","type-post","status-publish","format-standard","hentry","category-infos-businesswire"],"_links":{"self":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/42873","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=42873"}],"version-history":[{"count":1,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/42873\/revisions"}],"predecessor-version":[{"id":42874,"href":"https:\/\/stocks-future.com\/index.php?rest_route=\/wp\/v2\/posts\/42873\/revisions\/42874"}],"wp:attachment":[{"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=42873"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=42873"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stocks-future.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=42873"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}