1-year results from the HORIZON open-label extension study of ranibizumab (Lucentis, Genentech) for the treatment of exudative age-related macular degeneration show that treatment beyond 2 years relatively is safe and well tolerated, but previously treated patients who received ranibizumab monthly for 2 years may be susceptible to loss of vision with less-frequent dosing during the third year of treatment.
A new intravitreal insert (Iluvien, Alimera Sciences) currently in clinical trials manages a slow, long-term release of corticosteroid into the vitreous chamber. Preliminary results show the device to be very promising and possibly more favorable than other similar devices used for the treatment of diabetic macular edema.
In a dose-ranging phase IIb study, microplasmin 125 micrograms (ThromboGenics) was safe and demonstrated significant efficacy compared with placebo for inducing posterior vitreous detachment in eyes with macular holes or macular edema related to vitreomacular traction. Pivotal phase III trials are being planned.
A prismatic IOL (P-Flex, Rayner) is giving hope to patients with advanced age-related macular degeneration because of its novel design. A Fresnel prism in the IOL reflects images onto healthy retinas in patients with small macular lesions. No scotoma or diplopia has resulted from implantation of this IOL in two patients.
Neovascular age-related macular degeneration patients see significant gains in visual acuity when treated with vascular endothelial growth factor therapy
Visual acuity gains occurring in a 12-week, fixed-dose period were maintained throughout the 52-week trial of a novel agent (VEGF Trap-Eye, Regeneron Pharmaceuticals) for neovascular age-related macular degeneration. During the 9-month, as-needed dosing phase, the mean number of injections for all patients was two, and gains in visual acuity of up to nine letters were reported.
Adjuvant use of bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals) with ranibizumab (Lucentis, Genentech) reduced the reduced the number of ranibizumab injections needed to control choroidal neovascularization secondary to age-related macular degeneration. Use of the two drugs together resulted in better visual acuity outcomes than those achieved with ranibizumab alone.
Exudative age-related macular degeneration update: Phase II study outcomes encouraging for combination therapy treatment
When data were analyzed from 25 patients who reached the 18-month visit in a phase II trial evaluating epiretinal brachytherapy (EpiRad90 Ophthalmic System, NeoVista) with bevacizumab (Avastin, Genentech), they demonstrated that the novel combination was associated with a significant gain in vision, an acceptable safety profile, and with minimal need for additional anti-VEGF treatment beyond an initial two injections.
Sirion Therapeutics Inc. announced that a difluprednate ophthalmic emulsion 0.05% (Durezol) indicated for the treatment of inflammation and pain associated with ocular surgery is now commercially available.
Drug development for retinal disease is particularly challenging because traditional routes of drug delivery often are unable to achieve desired therapeutic levels, and the disease process often involves multiple complex pathways. An unmet medical need still exists—particularly for the two most prevalent diseases, age-related macular degeneration and diabetic retinopathy—but several phase III trials show promise.
Akorn Inc. has announced approval of an FDA new drug application (NDA) for ophthalmic gel 3.5% (Akten), a topical, ocular anesthetic formulation.