- Alcon Receives FDA Nod for AcrySof IQ Restor +3.0D Multifocal Toric IOL
Now approved by the FDA, Alcon’s AcrySof IQ Restor +3.0D Multifocal Toric Intraocular Lens is designed to address presbyopia and preexisting corneal astigmatism at the time of cataract surgery in adult patients who desire good near, intermediate and distance vision with an increased potential for spectacle independence. The product is also commercially available in the European Union, Australia, Canada, and several countries in Central and South America, and Asia. Alcon plans to commercialize AcrySof IQ the IOL in the United States on a rolling basis starting in the first quarter of 2017. Read more.
- Inotek Shares Drop 65 Percent After Glaucoma Treatment Trial Results
Shares of biotech Inotek Pharmaceuticals Corp. recently dropped about 66 percent in premarket trade after the company said a Phase III trial of trabodenoson for the treatment of primary open-angle glaucoma did not meet its primary endpoint. The drug is the company's leading clinical candidate, but the trial found a placebo response that was greater than observed in the Phase II trial. "We are disappointed that the primary endpoint of superiority at all 12 time points was not achieved," Chief Executive David P. Southwell said. The company says it will see further data later this quarter and will determine its next steps at that time. Read more.
- FDA Grants Orphan Drug Designation to Profounda
Profounda received the U.S. Food and Drug Administration's Orphan Drug Designation for the treatment of Acanthamoeba keratitis with miltefosine. Profounda licensed miltefosine (Impavido) from Knight Therapeutics in September 2015. Read more.
- FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for mCNV
Genentech announced that the U.S. Food and Drug Administration approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of individuals with myopic choroidal neovascularization, making it the first FDA-approved anti-vascular endothelial growth factor therapy to treat mCNV in the United States. This approval is based on the results of the Phase III RADIANCE study, which demonstrated that treatment with Lucentis provided superior visual acuity gains in people with mCNV compared with verteporfin photodynamic therapy. At three months, average VA gains for individuals treated with Lucentis were more than 12 letters, compared with 1.4 letters for those treated with vPDT. RADIANCE is a Phase III, randomized, double-masked, active-controlled study comparing the efficacy and safety of Lucentis (0.5 mg) vs. vPDT in 276 patients with visual impairment due to mCNV. Subjects were randomized into three treatment groups. Two groups randomized to Lucentis received injections guided by pre-specified retreatment criteria and the third group received treatment with vPDT. At month three, the Lucentis groups I and II had a mean change in best-corrected visual acuity of +12.1 and +12.5 letters from baseline, respectively, demonstrating a statistically significant improvement over the vPDT group III, which had a mean BCVA change of +1.4 letters from baseline. The efficacy between groups I and II were comparable. Adverse events were similar to those seen in other Lucentis trials. This is the fifth FDA-approved indication for Lucentis since the medicine was launched in 2006. Read more.
- Allegro Completes Enrollment in DEL MAR Phase IIb, Stage II Trial
Allegro Ophthalmics completed enrollment in the second stage of its DEL MAR trial evaluating the safety and efficacy of Luminate in combination and as an adjunctive therapy with anti-VEGFs in individuals with diabetic macular edema. Topline results from the DEL MAR Stage I monotherapy trial in which Luminate met its primary and secondary endpoints, demonstrating equivalence to bevacizumab monotherapy with half the number of injections, were released in October. DEL MAR Stage II is a double- masked, placebo-controlled, randomized, multicenter, five-month Phase IIb trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate 0.5 mg or 1 mg in combination with bevacizumab 1.25 mg and as an adjunctive therapy after treatment with a single treatment with bevacizumab 1.25 mg in patients with DME. Read more.
- GenSight Reports Sustained VA Gain in Phase I/II Study
GenSight Biologics reported additional promising results after 78 weeks of follow-up in its Phase I/II clinical trial. These results confirm the favorable safety and tolerability profile of GS010, while demonstrating sustainable visual acuity improvement in individuals with Leber hereditary optic neuropathy. Each cohort of three individuals was administered an increasing dose of GS010 through a single intravitreal injection in the eye most severely affected by the disease. Recruitment was completed in April 2015 and long-term follow-up is ongoing. Read more.
- Novartis Bolsters Eye-care Pipeline Through Encore Vision Acquisition
Novartis entered into a definitive agreement for the acquisition of Encore Vision, focused on the development of a novel treatment in presbyopia. The transaction is subject to customary closing conditions, including regulatory approval, and financial details of the transaction were not disclosed. Encore Vision's lead investigational product, EV06, is a topical treatment for presbyopia. In a phase I/II masked, placebo-controlled proof-of-concept study, 50 individuals were treated daily for 90 days with topical EV06 and 25 people with placebo. EV06 showed a statistically significant difference to placebo in distance-corrected near vision at all time points measured (from day eight). Read more.
- Health Canada Approves Trab 360 Trabeculotomy System
Sight Sciences received Health Canada approval for the Trab 360 Trabeculotomy System, indicated in Canada for the microcatheterization of Schlemm's canal and cutting of trabecular meshwork to lower intraocular pressure in patients with primary open-angle glaucoma. From a single clear corneal incision, surgeons can use the system to complete a 360-degree trabeculotomy. Read more.
- Sun Pharma Announces Positive Topline Results of Phase III Trial
Sun Pharma announced successful Phase III confirmatory clinical trial results for Seciera (cyclosporine A, 0.09% ophthalmic solution) for the treatment of dry-eye disease. The patented, novel, proprietary nanomicellar formulation of cyclosporine A 0.09% is a clear, preservative-free, aqueous solution developed by Ocular Technologies, recently acquired by Sun Pharma. In the 12-week, multicenter, randomized, double-masked, vehicle-controlled study, 744 dry-eye patients were treated either with Seciera or its vehicle. After 12 weeks of treatment, as compared to vehicle, Seciera showed statistically significant improvement in the primary end point, Schirmer's score (p<0.0001). Read more.