No difference between Macugen and triamcinolone
14 June 2007 – Ophthalmology Times Europe
A study, which was halted before the completion of enrolment, failed to demonstrate any difference in the visual outcomes or safety concerns in patients with neovascularization secondary to age-related macular degeneration (AMD) who were treated with photodynamic therapy (PDT) in combination with either intravitreal injections of Macugen (pegaptanib sodium) or triamcinolone, according to a presentation at this year’s meeting of the Association for Research in Vision and Ophthalmology (ARVO) […]
CoMentis Initiates Phase II Clinical Trial for AMD Eye Drop Therapy
South San Francisco, CA â€“ April 10, 2007â€“CoMentis, Inc. (formerly Athenagen), a privately held biopharmaceutical company, announced today the initiation of a Phase II clinical study of ATG3, the companyâ€™s topical eye drop therapy for neovascular age-related macular degeneration (NV-AMD). A proprietary ophthalmic formulation of mecamylamine, ATG3 is an antagonist of the nicotinic acetylcholine (nACh) receptor pathway that mediates angiogenesis. The drug was developed to effectively penetrate into the retina and choroid following topical eye drop administration.
This Phase II study is a double-masked, randomized, placebo-controlled clinical trial designed to evaluate the safety and efficacy of ATG3 in patients with NV-AMD (also known as â€œwetâ€™ AMD). Approximately 330 patients will be randomized to one of three treatment groups, administered by eye drop twice daily: two different doses of ATG3 or placebo. One eye per patient will receive the study treatment. All patients will be treated for up to 48 weeks, during which time they will be monitored for safety, tolerability and efficacy assessments. Patients will be assessed for change in visual acuity and macular thickness using ocular coherence tomography.
â€œIn January we completed our Phase I study of ATG3 in healthy volunteers and found excellent ocular safety following eye drop administration,â€ said Henry Hsu, M.D., Chief Medical Officer of CoMentis. â€œWe are very pleased to begin this international Phase II study as planned, and expect to have interim (six month) efficacy data by mid-2008. ATG3 could be the first topical angiogenic treatment for AMD and if approved, would compliment current therapies which require injection directly into the eye.â€ Inhibition of the nicotinic acetylcholine (nACh) receptor pathway, which was discovered at Stanford by two of CoMentisâ€™s founding scientists, also down regulates vascular endothelial-derived growth factor (VEGF) dependent angiogenesis. Studies in animal models have demonstrated excellent penetration of the proprietary ATG3 formulation to the retina and choroid following eye drop application as well as reduction of new blood vessel growth in the eye.
TargeGen Announces Successful Completion of Phase I Clinical Trial Of Topical AMD Drug TG100801
San Diego, CA â€“ Feb. 27, 2007 – TargeGen, Inc. has announced that the Company has completed a single-center Phase I clinical trial of TG100801 in 42 healthy volunteer subjects. TG100801 is a small molecule, topically applied (eye drop), multi-target kinase inhibitor that is being developed for the treatment of macular degeneration and other debilitating diseases of the eye. Preliminary results from this Phase I study suggest that TG100801 is well tolerated in humans at the low and high doses tested when applied topically twice daily for 14 days. Final study results are expected by the end of April 2007. TargeGen currently plans to initiate Phase II clinical trials in wet age-related macular degeneration (AMD) patients in mid-2007.
TG100801, applied daily in eye drop form, is designed to suppress disease related edema, angiogenesis and inflammation simultaneously. Edema, angiogenesis and inflammation are pathological hallmarks of AMD, diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR). Currently approved therapies for macular degeneration require repeated injection into the eye.
â€œThe successful completion of this â€˜first in humanâ€™ safety study with TG100801 represents a meaningful milestone for TargeGen and sets the stage for the near term initiation of human efficacy trials. We remain very optimistic about the potential for demonstrating efficacy in humans in the near future,â€ stated Peter G. Ulrich, President, CEO and Co-Founder of TargeGen.