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4 4  
5 5  = Overview =
6 6  
7 -Ophthotech is a biopharmaceutical company specializing in the development of novel therapeutics to treat ophthalmic diseases, with a focus on orphan and age-related retinal diseases. The company currently have two product candidates, Zimura® (avacincaptad pegol), an anti-complement factor C5 aptamer, and Fovista® (pegpleranib), an anti-platelet derived growth factor, or PDGF, aptamer. Prior to 2017, the Company's primary focus was on developing Fovista and Zimura for various types of age-related macular degeneration, or AMD, which is a disorder of the central portion of the retina, known as the macula, that may result in blindness. In December 2016, the company announced that two of its three pivotal, Phase 3 clinical trials for Fovista in combination with the anti-vascular endothelial growth factor, or anti-VEGF, drug Lucentis® (ranibizumab) for the treatment of wet AMD, failed to meet their primary endpoint. The company announced in early 2017 that the company had engaged a financial advisor to assist it in reviewing its strategic alternatives, including identifying potential business development opportunities. Also beginning in early 2017, the company undertook a reassessment of its development plans for Zimura and Fovista, which included an evaluation of the scientific rationale for potentially developing these product candidates in one or more other ophthalmic indications for which there is a high unmet need.
7 +Ophthotech (OPHT) is a biopharmaceutical company specializing in the development of novel therapeutics to treat ophthalmic diseases, with a focus on orphan and age-related retinal diseases. The company currently have two product candidates, Zimura® (avacincaptad pegol), an anti-complement factor C5 aptamer, and Fovista® (pegpleranib), an anti-platelet derived growth factor, or PDGF, aptamer. Prior to 2017, the Company's primary focus was on developing Fovista and Zimura for various types of age-related macular degeneration, or AMD, which is a disorder of the central portion of the retina, known as the macula, that may result in blindness. In December 2016, the company announced that two of its three pivotal, Phase 3 clinical trials for Fovista in combination with the anti-vascular endothelial growth factor, or anti-VEGF, drug Lucentis® (ranibizumab) for the treatment of wet AMD, failed to meet their primary endpoint. The company announced in early 2017 that the company had engaged a financial advisor to assist it in reviewing its strategic alternatives, including identifying potential business development opportunities. Also beginning in early 2017, the company undertook a reassessment of its development plans for Zimura and Fovista, which included an evaluation of the scientific rationale for potentially developing these product candidates in one or more other ophthalmic indications for which there is a high unmet need.{{footnote}}https://fintel.io/doc/sec-opht-ophthotech-10k-2018-march-05-17945{{/footnote}}
8 8  
9 9  On July 26, 2017, the company announced that Ophthotech is pursuing a strategy to leverage its clinical experience and retina expertise to identify and develop therapies to treat multiple ophthalmic orphan diseases for which there are limited or no treatment options available. The company believe that there are advantages of orphan drug development, including regulatory exclusivity, the potential for smaller clinical trials and the potential for an accelerated development timeline of the orphan retinal indications. In parallel, Ophthotech is continuing its on-going programs in age-related retinal diseases. The company believe that by leveraging its ophthalmic expertise and by focusing on orphan eye diseases together with its on-going programs in age-related retinal diseases, the company will have multiple potential opportunities to bring ophthalmic therapeutics to market. The company also are continuing its business development efforts to identify and potentially obtain rights to additional products, product candidates and technologies that would complement its strategic goals as well as other compelling ophthalmology opportunities.
10 10  
11 -**Zimura**
11 +== Zimura ==
12 12  
13 13  As part of its strategic review process, the company reassessed its development plans for its product candidate Zimura. The company applied the same rigor in reassessing its development plans for Zimura as the company used in performing diligence on third party opportunities considered as part of its strategic review process. The company's Zimura reassessment included an extensive review of scientific literature regarding the role of complement in ophthalmic diseases. Upon the conclusion of this reassessment, the company determined to accelerate its development of Zimura in additional ophthalmic indications. The company's ongoing and planned clinical studies for Zimura are:
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20 20  
21 21  The company plan to further reassess its development strategy for Zimura in treating GA in light of the results of a competitor’s Phase 3 clinical trials of a complement inhibitor being studied for the treatment of GA. These results are expected during the second half of 2017.
22 22  
23 -**Fovista**
23 +== Fovista ==
24 24  
25 25  In December 2016, the company announced initial, top-line data from two pivotal clinical trials, which the company refer to as OPH1002 and OPH1003, evaluating the safety and efficacy of 1.5mg of Fovista administered in combination with monthly 0.5mg Lucentis® (ranibizumab) anti-VEGF therapy compared to monthly 0.5mg Lucentis monotherapy for the treatment of wet AMD. The pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved for either OPH1002 or OPH1003. Moreover, the company did not observe any clinically meaningful visual benefit when 1.5mg of Fovista was added to a monthly regimen of 0.5mg Lucentis therapy for any subgroup of patients that Ophthotech has analyzed from the OPH1002 and OPH1003 trials, including subgroups based on baseline visual acuity, baseline lesion size or the baseline amount of the classic component of choroidal neovascularization, or CNV. Following the December 2016 data announcement, the company subsequently stopped treating patients in, and terminated, both the OPH1002 and OPH1003 trials. In light of the data from the OPH1002 and OPH1003 trials, the company also stopped treating patients in its additional Phase 2 clinical trials that were evaluating the potential additional benefits of Fovista administered in combination with anti-VEGF drugs in wet AMD patients, which the company previously referred to collectively as the Fovista Expansion Studies.
26 26  
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73 73  The company's ability to become and remain profitable depends on its ability to generate revenue in excess of its expenses. The company do not expect to generate significant product revenue unless, and until, the company obtain marketing approval for, and commercialize, any of its product candidates, which, if Ophthotech is successful, may take at least several years. The company may be unsuccessful in its efforts to develop and commercialize these product candidates. Even if the company succeed in developing and commercializing one or more of its product candidates, the company may never achieve sufficient sales revenue to achieve or maintain profitability. The company's capital requirements will also depend on many other factors, including whether Ophthotech is successful in its pursuit to acquire or in-license and subsequently develop additional product candidates or technologies. The company may need to obtain substantial additional funding in connection with its continuing operations. If Ophthotech is unable to raise capital when needed or on attractive terms, the company could be forced to delay, reduce or eliminate its research and development programs or any future commercialization efforts.
74 74  
75 75  = References =
76 +
77 +{{putFootnotes/}}
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