Opthea Limited American Depositary Shares - OPT STOCK NEWS

Opthea Limited (ASX:OPT; Nasdaq:OPT) has made significant strides in advancing its lead product OPT-302 for wet age-related macular degeneration (AMD). The company reported the treatment of its first patient in Phase 3 trials (ShORe and COAST) and received FDA Fast Track designation, expediting its development. Opthea's cash reserves stand at US$118.2 million, with R&D expenses increasing to US$25.9 million due to ongoing trials. Notably, the fiscal year ended June 30, 2021, resulted in a net loss of US$45.3 million, up from US$11.1 million the previous year.

Opthea Limited (ASX:OPT), a biopharmaceutical company focused on retinal diseases, announced that CEO Dr. Megan Baldwin will present at the H.C. Wainwright Ophthalmology Virtual Conference on August 17, 2021. The presentation will be available on-demand starting at 7:00 AM ET. Opthea is developing OPT-302, a leading product candidate in Phase 3 trials aimed at treating conditions like wet age-related macular degeneration and diabetic macular edema. The company emphasizes the inherent risks associated with biotechnology investments and advises seeking professional investment advice.

Opthea Limited (ASX:OPT; Nasdaq:OPT) has commenced patient recruitment in Canada for its Phase 3 clinical trials of OPT-302, aimed at treating wet age-related macular degeneration (AMD). Following Health Canada's approval, the ShORe and COAST trials will evaluate the efficacy of OPT-302 alongside existing therapies. The FDA has awarded OPT-302 Fast Track status due to positive previous trial outcomes, which could accelerate its approval process. Results from these trials are expected in the second half of 2023, potentially leading to global marketing authorizations.

Opthea Limited (ASX:OPT; Nasdaq:OPT) announced that the FDA granted Fast Track designation for its VEGF-C/-D trap inhibitor, OPT-302, aimed at treating neovascular (wet) age-related macular degeneration (AMD). This designation facilitates expedited clinical development, allowing for more frequent communications with the FDA and a Rolling Review of the Biologic Drug Application. OPT-302 holds potential as a differentiated treatment option, possibly improving vision outcomes for patients with unresolved responses to traditional therapies.

Opthea Limited (ASX:OPT; Nasdaq:OPT) announced the appointment of Mrs. Karen Adams as Vice President of Finance and Company Secretary, effective June 12, 2021. With extensive experience in finance, including her role as Chief Financial Officer at Victor Smorgon Group and prior experience at Nexvet Biopharma, Mrs. Adams brings valuable expertise in corporate governance and financial reporting. This leadership change occurs as Opthea advances its product OPT-302 through pivotal Phase 3 clinical trials for wet age-related macular degeneration, marking a significant phase in the company's growth.

Opthea Limited (ASX:OPT; Nasdaq:OPT) has appointed Dr. Julia Haller and Ms. Judith Robertson as independent Non-Executive Directors as of June 1, 2021. Their extensive backgrounds in ophthalmology and commercial life sciences aim to enhance Opthea's clinical and commercialization strategies. The company is focused on advancing its lead product candidate, OPT-302, which is undergoing pivotal Phase 3 trials for wet age-related macular degeneration (AMD), with top-line data expected in 2023. The new board members are expected to provide significant expertise in navigating these developments.

Opthea Limited (ASX:OPT; Nasdaq:OPT) has announced the resignation of Mr. Michael Tonroe as Company Secretary and CFO, effective June 24, 2021. The company is in search of a qualified replacement to manage financial reporting for its dual listings on ASX and Nasdaq. Mr. Tonroe departs as Opthea prepares for its global Phase 3 clinical development for OPT-302 targeting wet age-related macular degeneration. CEO Dr. Megan Baldwin acknowledged Mr. Tonroe's significant contributions since 2014, highlighting his role in the company’s growth and recent Nasdaq listing.

Opthea Limited (ASX:OPT; Nasdaq:OPT) has received an initial Pediatric Study Plan (iPSP) waiver from the FDA for OPT-302, its leading candidate for wet age-related macular degeneration treatment. This waiver eliminates the need for additional pediatric studies, streamlining the pathway to a marketing application. CEO Dr. Megan Baldwin highlighted this milestone as vital for ongoing Phase 3 trials in adults, aiming for potential regulatory approval. The company focuses on unmet needs in retinal diseases, combining OPT-302 with anti-VEGF-A therapies for improved efficacy.

Opthea Limited has announced the treatment of the first patient in its Phase 3 pivotal studies for OPT-302, targeting treatment-naïve wet age-related macular degeneration (AMD). Conducting two global trials (ShORe and COAST), Opthea aims to assess the efficacy of OPT-302 combined with anti-VEGF-A therapies compared to monotherapy. The ShORe trial involves 990 patients, focusing on improving visual acuity over 52 weeks. The promising results from the Phase 2b trial, showing significant visual gains, support this new phase. Top-line data is expected in 2023, paving the way for potential FDA and EMA applications.