Akorn Inc. has announced approval of an FDA new drug application (NDA) for ophthalmic gel 3.5% (Akten), a topical, ocular anesthetic formulation.
Inspire Pharmaceuticals Inc., phase I clinical trial, INS117548 ophthalmic solution, glaucoma, safety, tolerability, and IOP-lowering effects, early-stage glaucoma, ocular hypertension
The development of endophthalmitis after intravitreal injection of anti-vascular endothelial growth factor drugs is a rare event, with an incidence of 0.03% for treated cases and 0.02% for culture-positive cases.
Three monthly injections of ranibizumab, 0.3 and 0.5 mg, appear to provide benefit to patients with macular edema due to central retinal vein occlusion or branch retinal vein occlusion. Foveal thickness decreased significantly with both doses, and there was a concomitant increase in the visual acuity. Most patients require more than three injections to maintain the benefit. The average duration of treatment and the final visual outcomes are not yet known.
Researchers have successfully used hollow microneedles to deliver minute particle suspensions into the suprachoroidal space in rabbit, pig, and human eyes in vitro.
Study shows primary intravitreal bevacizumab provides stability, improvement in diffuse diabetic macular edema
A comparison of two doses of intravitreal bevacizumab (Avastin, Genentech) showed that both resulted in stability or improvement in visual acuity and central macular thickness in patients with diffuse diabetic macular edema (DME) over a 12-month period.
Pegaptanib sodium (Macugen, [OSI] Eyetech/Pfizer) used as an adjunct to laser therapy has a significant impact in the treatment of patients with progressive diabetic retinopathy, offering much hope for the prognosis of patients who have this disorder.
Neovascular age-related macular degeneration treated with long-term use of intravitreal ranibizumab (Lucentis, Genentech) was safe and well tolerated in a group of patients participating in an extension study. Between the original studies and the extension trial, patients were followed for approximately 4 years, during which no safety signals were observed. Although problems linked to vascular endothelial growth factor inhibition were suggested, the lack of a control group makes proving a correlation difficult.
Levofloxacin ophthalmic solution 1.5% (Iquix, Vistakon Pharmaceuticals), used to treat bacterial keratitis, has no adverse effects on the corneal endothelium after 2 weeks of intensive dosing for a total of 224 doses of the drug.
ISTA Pharmaceuticals Inc. has licensed North American rights to nasal dosage forms of bepotastine, an investigational product from Tanabe Seiyaku Co. Ltd. ISTA said it expects to complete the formulation of nasal bepotastine next year and begin clinical development in late 2008 or early 2009.