RXI-109 injection for retinal scarring in neovascular age-related macular degeneration was safe and well tolerated in a phase 1/2 clinical trial, according to a press release from RXi Pharmaceuticals.The open-label, multi-dose, dose escalation study in…
Author: Healio ophthalmology
FDA tentatively approves Alembic’s bimatoprost solution
The FDA has issued tentative approval for Alembic Pharmaceuticals’ abbreviated new drug application for bimatoprost ophthalmic solution 0.03%, the company announced in a press release.
Therapeutically equivalent to Allergan’s Latisse, Alembic’s product is indicated for the treatment of hypotrichosis of the eyelashes, the release said.
The launch of the product is contingent upon litigation between the two companies, which is currently underway in the District Court of New Jersey.
VIDEO: Luminate blocks integrin receptors, reduces oxidative stress
VANCOUVER, British Columbia — At the American Society of Retina Specialists meeting, Peter K. Kaiser, MD, reviews differences between Luminate (risuteganib, Allegro), which decreases oxidative stress from diabetes by blocking integrin receptors, and Avastin (bevacizumab, Genentech), which works farther downstream in the oxidative pathway, at the level of inflammation and vascular permeability.
VIDEO: Baseline diabetic retinopathy severity predictive of treatment success
VANCOUVER, British Columbia —Mimi Liu, MD, associates baseline characteristics and clinical features with treatment success in her presentation at the American Society of Retina Specialists meeting: “Predictors of early improvement in diabetic retinopathy severity in patients treated with ranibizumab.”
VIDEO: Early treatment with Iluvien reduces adjunctive treatment burden in DME
VANCOUVER, British Columbia — Early introduction of Alimera Sciences’ Iluvien implant (fluocinolone acetonide) in patients with diabetic macular edema will yield the best results in maintenance of vision and stabilization of macular edema, as well as reduction in treatment burden of adjunctive treatments, Sam E. Mansour, MD, said at the American Society of Retina Specialists meeting, where he presented data from the PALADIN and USER studies.
VIDEO: Stem cell-derived RPE under study in geographic atrophy patients
VANCOUVER, British Columbia — At the American Society of Retina Specialists meeting here, Amir Kashani, MD, discusses a phase 1/2a study regarding stem cell-derived retinal pigment epithelium to improve vision loss in patients with geographic atrophy.
Ophthotech posts quarterly loss
Ophthotech Corporation reported a net loss of $13.2 million, or $0.37 per diluted share, in the second quarter of 2018, compared to a net loss of $22.2 million, or $0.62 per share, for 2017’s second quarter, the company announced in a press release.
General and administrative costs decreased from $8.6 million in 2017’s second quarter to $6.3 million for the same period of 2018, while research and development costs decreased from $15.7 million to $8.5 million.
The company has $146 million in cash and cash equivalents as of June 20, (Read more...)
Dropless TriMoxi trial to begin in Canada
Advanced Dosage Forms Inc., the Canadian partner to Imprimis Pharmaceuticals, will begin a clinical trial of the Dropless TriMoxi formulation for cataract surgery, according to a press release.
The prospective, randomized, controlled, multicenter, crossover study will enroll 200 bilateral cataract surgery patients to compare Dropless TriMoxi (triamcinolone acetonide-moxifloxacin) to traditional eye drop therapy to assess drug safety, patient preference and pharmacoeconomic measures, the release said.
“The goal of the study is to clinically validate the experience of American
Nicox initiates study of dual-action glaucoma drug
Nicox S.A. has enrolled the first 10 patients in a phase 2 study of NCX 470, a nitric oxide-donating prostaglandin analog, for the reduction of IOP, according to a press release.
The multicenter, double-masked, parallel group, dose-ranging study will compare the safety and efficacy of NCX 470 against latanoprost 0.005% in 420 adults with open-angle glaucoma or ocular hypertension, the release said.
“NCX 470 is a new chemical entity which uses bimatoprost, a prostaglandin analog, as a scaffold for attaching an NO-donating moiety in order to achieve a dual mechanism (Read more...)
Long-term results support PRP or ranibizumab for proliferative diabetic retinopathy
Jeffrey G. Gross
VANCOUVER, British Columbia — The 5-year outcomes from the DRCR.net Protocol S study support the use of either ranibizumab or panretinal photocoagulation for the treatment of proliferative diabetic retinopathy, according to a speaker here.
“These findings support either ranibizumab or PRP as viable treatment for proliferative diabetic retinopathy. Patient-specific factors should be considered,” Jeffrey G. Gross, MD, said at the American Society of Retina Specialists annual meeting.
The previously published 2-year outcomes for the study showed the mean change in
AbbVie net revenues increase in second quarter
AbbVie reported net earnings of $1.983 billion in the second quarter of 2018 compared with net earnings of $1.915 billion in 2017’s first quarter.
The company posted GAAP net revenues of $8.278 billion in the quarter compared with $6.944 billion a year ago, according to a company press release.
Operating expenses increased from $4.3 million in the second quarter of 2017 to $5.5 billion in the second quarter of 2018.
Global sales of Humira (adalimumab) increased 10% for the quarter to $5.185 billion.
Trump administration creates insurance plans it says are affordable, medical ethicist says are ‘junk’
Alex Azar
A new battle has begun in the ongoing war between the Trump administration and most medical societies on what the definition of health care insurance should be.
According to HHS, while enrollment data showed stable enrollment for subsidized exchange coverage, the number of people enrolled in the individual market without subsidies dropped 20% in the U.S. in 2017 as premiums increased by 21%. The agency also said many state markets experienced “far more dramatic” enrollment declines, with unsubsidized enrollment dropping by more than 40% in more than (Read more...)
VIDEO: Eylea improves nonproliferative diabetic retinopathy in phase 3 study
VANCOUVER, British Columbia — Charles C. Wykoff, MD, PhD, discusses 24-week results of the phase 3 PANORAMA study regarding Eylea (aflibercept, Regeneron) for the treatment of nonproliferative diabetic retinopathy at the American Society of Retina Specialists meeting.
More inflammation observed after aflibercept vs. ranibizumab injection
VANCOUVER, British Columbia — While eye pain outcomes were similar within a week of injection of either aflibercept or ranibizumab in patients with diabetic macular edema, more anterior chamber inflammation was seen in patients receiving aflibercept, although not to a level of statistical significance.
“Anterior chamber inflammation occurred more frequently in patients receiving aflibercept compared to ranibizumab, but the difference was not statistically significant. There was no difference in the vitreous inflammation and the numbers were quite small,” Nikolas J.S. London,
FDA approves Wills Eye Hospital for subretinal device study
The FDA has approved an early feasibility study of Retina Implant’s Alpha AMS subretinal device in blind patients with retinitis pigmentosa, Wills Eye Hospital announced in a press release.
Wills Eye Hospital, the sole sponsor of the study in North America, will enroll up to eight subjects for implantation of the investigational device, the release said. The Alpha AMS device, which is CE marked in Europe, is designed to replace the eye’s nonfunctioning and absent photoreceptors and to restore some functional vision by stimulating the remaining parts of the visual (Read more...)
Omeros, Sandoz end patent infringement litigation
A patent infringement lawsuit against Sandoz regarding an abbreviated new drug application for a generic version of Omidria has been dismissed following an agreement between the companies, according to a press release from Omeros.
Sandoz has agreed to amend its ANDA and no longer seek FDA approval to market a generic version of Omeros’ cataract surgery drug until its Orange Book-listed patents expire, the release said.
Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution) was launched by Omeros in 2015 and Sandoz filed its ANDA 2 years later; with the (Read more...)
VIDEO: Quarterly intervals an option for individualized dosing of anti-angiogenics
VANCOUVER, British Columbia ― David Eichenbaum, MD, discusses quarterly dosing of anti-angiogenics for neovascular macular degeneration, data he presented at the American Society of Retina Specialists meeting.
Fluorescein angiography, high magnification detect retinal changes in Zika patients
VANCOUVER, British Columbia — High magnification and fluorescein angiography detected retinal and vasculature changes in a consecutive case series of children diagnosed with Zika infection, according to a speaker here.
“Fluorescein angiography was useful in detecting the discrete retinal defects, which are unspecific for congenital Zika syndrome, but they might explain the high visual impairment rates in these children. Also, this study has shown that the retinal vasculature in congenital Zika syndrome may be affected, and this might be caused by the direct aggression of the virus
VIDEO: Seeking the ‘sweet spot’ for treating diabetic retinopathy
VANCOUVER, British Columbia ― Michael J. Elman, MD, discusses findings regarding early treatment of diabetic retinopathy with Lucentis (ranibizumab, Genentech), which he presented here at the American Society of Retina Specialists meeting.
First patient dosed in Kala dry eye treatment trial
The first patient has been dosed in a phase 3 trial of Kala Pharmaceuticals’ short-term dry eye treatment KPI-121 0.25%, the company announced in a press release.
The STRIDE 3 multicenter, randomized, double-masked, placebo-controlled, parallel arm trial will compare KPI-121 0.25% to placebo in approximately 900 patients with dry eye, with the primary endpoint being patient report of discomfort severity at day 15. Patients will be dosed four times a day for 14 days.
“If approved, KPI-121 0.25% could be the first FDA- approved product for the short-term treatment of (Read more...)