| Over a week ago | ||||
Opthea announced that it… Opthea announced that it has finalized the protocol study designs and start-up activities in readiness for the initiation of the Phase 3 ShORe and COAST pivotal clinical trials of OPT-302 in wet age-related macular degeneration, or AMD. Finalization of the Phase 3 trial protocols follows productive consultations with the FDA, EMA and key opinion leaders, or KOLs, in wet AMD. The trial protocols have also been submitted to relevant regulatory agencies, institutional review boards and human research ethics committees. The global, multi-center, double-masked, sham-controlled, pivotal Phase 3 clinical trials will each enroll approximately 990 treatment-naive patients and assess the efficacy and safety of intravitreal 2.0 mg OPT-302 in combination with 0.5 mg ranibizumab or 2.0 mg aflibercept, compared to ranibizumab or aflibercept monotherapy, respectively. In addition, extended durability of the OPT-302 treatment effect on clinical outcomes with less frequent every eight-weekly dosing will be compared with OPT-302 administered on an every four-weekly dosing regimen, in combination with each VEGF-A inhibitor. If effective in these Phase 3 studies, OPT-302 could be adopted for administration with either Eylea or Lucentis which had combined sales for retinal diseases of $11.9B in 2019. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52 for OPT-302 combination therapy compared to anti-VEGF-A monotherapy. Each patient will continue to be treated for a further year to evaluate extended safety and tolerability over a two-year period. Opthea remains on track to initiate the trials in Q1 and to report top-line data in the second half of 2023. If the results at the completion of the primary efficacy phase at week 52 of the Phase 3 clinical trials are favorable, the company intends to submit biologics license and marketing authorization applications with the FDA and EMA respectively for marketing approval for OPT-302 for the treatment of wet AMD in the United States, European Union and other global territories. | ||||
| Over a month ago | ||||
Virtual Meetings to be… Virtual Meetings to be held January 27-28 hosted by Oppenheimer. | ||||
Virtual Meetings to be… Virtual Meetings to be held January 27-28 hosted by Oppenheimer. | ||||
Virtual Meetings to be… Virtual Meetings to be held January 27-28 hosted by Oppenheimer. | ||||
| Over a quarter ago | ||||
Citi analyst Yigal… Citi analyst Yigal Nochomovitz initiated coverage of Opthea with a Buy rating and $48 price target. The company is developing OPT-302, a first-in-class VEGF-C/-D inhibitor designed to drive improved visual acuity outcomes over the current standard of care in wet age-related macular degeneration, Nochomovitz tells investors in a research note. The analyst models a 70% probability of success with peak risk-adjusted revenues of $1.2B in the U.S. | ||||
As previously reported,… As previously reported, SVB Leerink analyst Geoffrey Porges initiated coverage of Opthea with an Outperform rating and $33 price target. The analyst cites his forecast for revenue from the company's only product, OPT-302, which will soon enter two large phase III trials in wet AMD, and has the potential to be a meaningful participant in the growing $11B market for direct retinal medicines for diseases of neovascularization, including wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. Over time, Porges expects Opthea to establish the activity of OPT-302 in combination with biosimilar VEGF A antibodies, and to also develop a co-formulated product or products that can reduce the burden of additional injections with the current presentation. | |
SVB Leerink analyst… SVB Leerink analyst Geoffrey Porges initiated coverage of Opthea with an Outperform rating and $33 price target. | |
Oppenheimer analyst… Oppenheimer analyst Hartaj Singh initiated coverage of Opthea with an Outperform rating and $36 price target. The analyst argues that with a strong scientific rationale, good early/mid-stage clinical data, and an execution-focused management team, Opthea could be well on its way to creating a robust ophthalmology franchise around OPT-302, its lead asset in combination with currently approved anti-VEGF A inhibitors in wAMD and DME. Two Phase 3 trials expect to initiate in the first half of 2021, finalize recruitment in the first half of 2022, and read out in the second half of 2023, positioning Opthea, an October IPO, well to capitalize on the potential of OPT-302, Singh contends. The analyst is "bullish on the approach." | |
Truist analyst Robyn… Truist analyst Robyn Karnauskas initiated coverage of Opthea (OPT) with a Buy rating and $25 price target. The analyst notes that the company is developing a novel add-on drug to current treatments - including EYLEA (REGN) and Lucentis (RHHBY) - for common diseases that cause blindness. Karnauskas adds that with many patients still losing their vision on current drugs, there continues to be a "high unmet need", as she models a 35% probability of success of OPT-302 with peak 2030 adjusted sales estimate of $0.6B in U.S. / E.U. markets. | |
Truist analyst Robyn… Truist analyst Robyn Karnauskas initiated coverage of Opthea with a Buy rating and $25 price target. |