Over the course of a decade, 54% of drugs and biologics in late-stage trials failed due to poor efficacy or safety concerns, according to findings published in JAMA Internal Medicine.Researchers published the trial results in peer-reviewed journals for…
Author: Healio ophthalmology
Nicox to resubmit cetirizine NDA after manufacturing concerns are addressed
Nicox S.A. announced that it received a Complete Response Letter from the FDA regarding the New Drug Application for AC-170 as a result of an inspection at a third-party facility that produces the active pharmaceutical agent, cetirizine, and supplies it to the manufacturer of the finished product.AC-170 is Nicox’s novel, proprietary, cetirizine eye drop formulation for treating ocular itch associated with allergic conjunctivitis, according to a press release from the company.
Medicaid expansion leads to financial benefits in hospitals
Hospitals in states that expanded Medicaid experienced reduced uncompensated care costs and increased revenue compared with hospitals in states that did not expand Medicaid, according to data published in JAMA.Fredric Blavin, PhD, from the Urban Instit…
AAO task force releases statement on adverse events for premium IOLs
An American Academy of Ophthalmology task force released a consensus statement on new definitions of adverse events for premium IOLs, including toric, accommodating, multifocal and phakic IOLs. The task force expanded the “historical control” publication of adverse events to accommodate the development of new premium IOLs, which may present additional adverse events compared with monofocal IOLs, according to the statement.
FDA grants priority review for Lucentis for myopic CNV
The FDA accepted a supplemental biologics license application and granted priority review for Lucentis for the treatment of myopic choroidal neovascularization, according to a Genentech press release.The application is based on the 12-month, randomized, double-masked, multicenter phase 3 RADIANCE study, in which Lucentis (ranibizumab) provided “superior visual acuity gains” in patients with myopic CNV compared with verteporfin photodynamic therapy, the release said.
Risk factors identified for RPE tears after ranibizumab injections in wet AMD patients
Patients with neovascular age-related macular degeneration and pigment epithelial detachment who receive intravitreal ranibizumab injections are at a higher risk of experiencing retinal pigment epithelium tears, according to a study. The retrospective study at Konyang University College of Medicine, Seoul, South Korea, included 407 treatment-naïve eyes of 377 patients with wet AMD. Three monthly injections of intravitreal Lucentis (ranibizumab, Genentech) were given to each patient, with additional injections given as needed. Retinal pigment epithelium (RPE) tears were identified by color fundus photographs, fluorescein angiography images, autofluorescence images and spectral-domain OCT.
PUBLICATION EXCLUSIVE: Ophthalmologist-entrepreneurs need a thick skin and plenty of patience to succeed
Coming up with an idea is easy. Developing the idea into a product and full-fledged company is a difficult but ultimately rewarding process for ophthalmologists looking to branch out as entrepreneurs.Every product or company starts out as a singular initial idea that someone chooses to either pursue or ignore, Gary N. Wörtz, MD, founder of Omega Ophthalmics, said
Copay assistance programs not solution to high drug prices
Copay assistance, a seeming resolution to the drug pricing dilemma, is actually the problem, according to a commentary published in Annals of Internal Medicine.The 600% price hike of Mylan’s EpiPen over a period of 8 years is the most recent outcry regarding expensive drug prices, Peter A. Ubel, MD, of Duke University and Peter B. Bach, MD, of Memorial Sloan Kettering Cancer Center, wrote in their commentary.
Ocular Therapeutix begins enrollment for phase 3 clinical trial with OTX-TP
Ocular Therapeutix announced the enrollment of the first patient in the first of two planned phase 3 clinical trials with OTX-TP for the treatment of glaucoma and ocular hypertension. OTX-TP, which is placed in the canaliculus, is designed to deliver t…
Katena Products acquires Eagle Vision
Eagle Vision has been purchased by Katena Products, according to a Katena press release.Eagle Vision’s products, including punctal plugs, are used by U.S. and international ophthalmologists and optometrists to treat dry eye syndrome, the release said. Katena will add these products to its line of ophthalmic instruments and devices.
Asymmetric multifocal IOL improves visual acuity at low level of residual astigmatism
A rotationally asymmetric multifocal IOL was associated with positive visual outcomes at low levels of residual refractive astigmatism, according to a study conducted in the United Kingdom.“The angle of residual corneal astigmatism in relation to IOL placement did not have a significant effect on postoperative outcomes,” the study authors said.
Second-line tocilizumab seen as effective in patients with JIA-associated uveitis
Tocilizumab therapy was effective in patients with severe juvenile idiopathic arthritis-associated uveitis who previously failed conventional immunosuppressive drugs with at least one anti- tumor necrosis factor agent, according to this study.The resea…
Speaker gives update on DRCR.net activities, findings, new protocols
At Retina 2016, vice chair of the Diabetic Retinopathy Clinical Research Network Judy E. Kim, MD, gives an overview of the network’s activities and findings for the previous year, and outlines study design for protocols U, V and AA.
Alternative therapies for PDR considered
Although the current longstanding treatment algorithm for proliferative diabetic retinopathy is effective, perhaps in this age of anti-VEGF availability, alternative treatments should be considered, according to Michael S. Ip, MD, who spoke at Retina 2…
Experts outline parameters for myopia control trials
SILVER SPRING, Md. – Patient selection, efficacy endpoints, acceptable rate of microbial keratitis and patient-reported outcomes are all crucial factors in a randomized controlled clinical trial designed to evaluate the effectiveness of a device to control myopia progression, according to expert panelists.Representatives from the major optometry and ophthalmology organizations co-sponsored a workshop held last week at the FDA to suggest guidelines for future clinical trials involving contact lenses with this indication in children.
Teenager presents with unilateral proptosis
The Ophthalmology service was consulted to evaluate a 14-year-old girl in the emergency department with unilateral proptosis. For 3 months she was symptomatic with progressive right-sided nasal congestion, and in the 2 weeks before presentation, she noted right eye tearing. She became concerned when she noticed her right eye “bulging,” and her parents brought her to the emergency department. She reported mild, vague changes in her vision as well as intermittent tearing, but she denied blurry vision, double vision, color desaturation, eye pain or pain with eye movements.She was a (Read more...)
Round table: Pediatric ophthalmologists address ‘hot topic’ of stemming myopia progression
Robert S. Gold, MD: Our first topic is an extremely hot topic in pediatric ophthalmology today, and that is myopia: the disease process of myopia, the prevention of progression of myopia, and what treatment modalities we are willing to implement to a…
What is the single most difficult aspect of launching your own company or bringing your product to market?
POINTFor any new company looking to bring a unique product to market, it is crucial that a balance is struck between each of the relevant constituencies across each stage of the process. This is particularly difficult in the field of ophthalmology when dealing with patients having either no vision or very poor visual acuity (such as hand motion). Indeed, it is not uncommon that the two most important constituencies — the regulatory agencies and the payers — would have divergent or misaligned focal points. Gaining the satisfaction of both is (Read more...)
Ophthalmologist-entrepreneurs need a thick skin and plenty of patience to succeed
Coming up with an idea is easy. Developing the idea into a product and full-fledged company is a difficult but ultimately rewarding process for ophthalmologists looking to branch out as entrepreneurs.Every product or company starts out as a singular initial idea that someone chooses to either pursue or ignore, Gary N. Wörtz, MD, founder of Omega Ophthalmics, said.
Tooling up for glued IOLs: Significance of three-piece IOLs and injectors
IOLs and their respective materials and designs are intended to be inert and made in a way so that they are easy to handle concerning the folding-unfolding aspect and implantation into the eye. The importance of the overall length of an IOL for intrasc…