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| Volume 13, Number 13 |
May 12, 2008
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Pfizer drops trials of NicOx glaucoma drug |
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| A glaucoma drug developed by French pharmaceutical company NicOx S.A. (Paris, France), a partner of Pfizer (New York, N.Y.), will not enter into Phase III trials due to the drug’s failure to achieve its primary endpoint in Phase IIa trials, NicOx said in a press release. The drug, PF-03187207, a nitric oxide-donating prostaglandin analog, was being jointly developed by Pfizer and NicOx. Pfizer, which conducted the U.S. Phase II trial, decided not to launch a global Phase III trial based on the study results. The primary endpoint was to determine if any PF-03187207 dose was superior to Xalatan 0.005% (latanoprost, Pfizer) for the reduction of elevated diurnal intraocular pressure. On the primary endpoint at 28 days, PF-03187207 showed a 12% improvement over Xalatan 0.005%, which was not statistically significant. Pfizer said that while study yielded “interesting data,” it ultimately did not meet the criteria for launching a Phase III program. Pfizer is currently conducting a Phase II study for PF-03187207 in Japan, and will consider possible registration in Asia, NicOx said in the release. |
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RegenRx awarded patent in Hong Kong |
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RegenRx Biopharmaceuticals (Bethesda, Md.) has been granted a patent by the Hong Kong Intellectual Property Department for the use of Tβ4 analogues, isoforms, and derivatives “to accelerate corneal wound healing and reverse or inhibit eye degeneration,” the company said in a press release. Tβ4’s corneal wound healing capabilities are being investigated in a Phase II trial. This trial is evaluating the use of an ophthalmic formulation, RGN-259, in diabetic vitrectomy patients.
Tβ4 is a synthetic version of a naturally occurring human peptide, and promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and the down-regulation of inflammation. |
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FDA grants request to expand Neovista’s CABERNET trial |
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CABERNET, a multicenter, randomized, controlled study, has been given U.S. regulatory approval to increase the number of sites included in the pivotal Phase III trials, study sponsor Neovista (Fremont, Calif.) said.
The CABERNET (CNV Second to AMD Treated with BEta RadiatioN Epiretinal Therapy) trial seeks to assess the safety and efficacy of NeoVista’s epiretinal brachytherapy for wet age-related macular degeneration (AMD), and will enroll 450 patients worldwide. The study will evaluate NeoVista’s epiretinal brachytherapy, delivered using a limited vitrectomy, concominant with two intravitreal injections of Lucentis (ranibizumab, Genentech, San Francisco, Calif.) vs. Lucentis alone. |
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Bepreve demonstrates efficacy in Phase III trial |
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Bepreve (bepostatine) demonstrated “highly statistically significant reductions” in ocular itching in its second Phase III clinical study, developer ISTA Pharmaceuticals (Irvine, Calif.) said in a press release.
The multicenter Conjunctival Allergen Challenge (CAC) study assessed the onset and duration of effect of two concentrations in 130 patients with a history of ocular allergies. Both concentrations demonstrated statistically significant effects in the primary study endpoint of ocular itching. Both concentrations also showed statistically significant effects in terms of the speed of response, as well as in the secondary endpoints measuring additional allergy symptoms and nasal symptoms. There were no serious ocular side effects. ISTA plans to file a New Drug Application for Bepreve in the second half of 2008. |
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EYEWORLD WEEK Online edited by David Laber and
Enette Ngoei
EyeWorld Week Online (ISSN 1089-0319), a digital publication of the American Society of Cataract and
Refractive Surgery and the American Society of Ophthalmic Administrators, is published every Monday,
distributed by e-mail, and posted live on Monday mornings.
Chief Medical Editors: Stephen A. Obstbaum, M.D., and Stephen S. Lane, M.D.
For sponsorship oppurtunities or membership information, contact:
ASCRS•ASOA • 4000 Legato Rd., • Suite 700 • Fairfax, VA 22033 • Phone:703-591-2220 • Fax: 703-591-0614 •
E-mail: ASCRS
Opinions expressed in EyeWorld Week do not necessarily reflect those of the ASCRS•ASOA.
Mention of products or services does not constitute an endorsement by the ASCRS•ASOA.
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