The U.S. Senate Committee on Health, Education, Labor and Pensions favorably reported legislation that would streamline the FDA’s evaluation process for medical devices, one of seven biomedical innovation bills currently advancing to the full Senate for consideration.The FDA Device Accountability Act of 2015 (S. 1622), sponsored by Sens. Richard Burr, R-N.C., and Al Franken, D-Minn., and co-sponsored by Mark Kirk, R-Ill., is intended to ensure the “least burdensome means” of evaluating medical devices, according to the bill’s authors.
Author: Healio ophthalmology
Protein targets tissue factor, angiogenesis in CNV related to AMD
MIAMI — A protein that targets tissue factor in neovascular age-related macular degeneration was well tolerated in a phase 1 study, a speaker told colleagues here. Carl D. Regillo, MD, reviewed results of a phase 1 study of ICON-1 (Iconic Therapeutics) in the treatment of neovascular AMD at Angiogenesis, Exudation, and Degeneration 2016.
Ocular Therapeutix strategizes design for phase 3 trials of OTX-TP
Ocular Therapeutix is planning to initiate the first of two phase 3 clinical trials of OTX-TP for the treatment of glaucoma and ocular hypertension in the third quarter based on feedback from a recent meeting with the FDA, the company announced in a pr…
Novaliq begins patient enrollment for phase 2 trial of CyclASol for dry eye disease
Novaliq has started to enroll patients in a phase 2 trial of CyclASol to treat dry eye disease, the company announced in a press release. The randomized, double-masked, placebo-controlled multicenter phase 2 trial will evaluate the safety, efficacy and…
Carl Zeiss reports €262.6 million in revenue in first quarter
Carl Zeiss Meditec reported €262.6 million in revenue in the first quarter of the fiscal year compared with €241.1 million reported in the same quarter of the previous fiscal year, according to a press release. Revenue in the Surgical Ophthalmology strategic business unit was reported at €92.6 million in the first quarter, a 13.6% increase from €81.6 million in the same quarter of the previous year.
Wide range of treatments available to optimize ocular surface
The lid margin plays an important role in maintaining ocular surface health. Inflammation of the lid margin in the form of anterior or posterior blepharitis can cause ocular surface inflammation and degrade the quality of the tear film. Before any elec…
Study shows possible genetic link to persistent retinal fluid in AMD
MIAMI — Persistent retinal fluid in eyes that have been treated with anti-VEGFs for neovascular age-related macular degeneration may have a genetic basis, a speaker told colleagues here.“Here we are, basically 10 years after anti-VEGF was introduced, and we’re seeing where the unmet needs are. Only 30%, a third of patients, who are treated gain three lines of vision. That would have been amazing 10 years ago, but we want more. About a third of patients also have persistent fluid after 1 year of treatment,” Philip J. Rosenfeld, MD, PhD, (Read more...)
Iridex receives CE mark for Cyclo G6 laser system in Europe
Iridex has received CE mark to commercialize the Cyclo G6 laser system in Europe for the treatment of glaucoma and its symptoms, the company announced in a press release. The Cyclo G6 laser system is designed to treat a range of glaucoma diseases and features Iridex’s MicroPulse tissue-sparing technology, as well as a family of single-use probes that connect to a laser console.
Senate committee proposes updates to FDA application requirements for reusable devices
In a recent session, the Senate Committee on Health, Education, Labor and Pensions favorably reported a bill requiring manufacturers of reusable medical devices to submit cleaning instructions and validation data to the FDA before bringing these devices to market. The bill also would require the FDA to develop guidance on when manufacturers should seek clearance from the agency before marketing their products.The “Preventing Superbugs and Protecting Patients Act” (S. 2503), sponsored Sen. Patty Murray, D-Wash., references several incidents of drug-resistant infections related to closed-channel duodenoscopes brought to light in the (Read more...)
Publication Exclusive: 29-year-old woman presents with subacute vision loss and headaches
A 29-year-old obese white woman with a known history of idiopathic intracranial hypertension, or IIH, presented to the New England Eye Center with 1 month of progressively decreasing vision in her right eye and positional headaches. She was diagnosed w…
Lampalizumab offers realistic hope for atrophic AMD
Lampalizumab may offer hope for people affected by atrophic age-related macular degeneration. Phase 3 trials are ongoing, and research is focusing on identifying patients who may better respond to the treatment.“We should be grateful for every small step forward, as atrophic AMD is the most difficult form of the disease. In wet AMD we treat to destroy something abnormal, while here we are trying to move forward the internal clock of cells that are programmed to die, which is an infinitely greater challenge,” Jordi Monés, MD, PhD, said in an (Read more...)
Monitoring of ocular perfusion pressure during vitrectomy may prevent visual field defect
Continuous monitoring of mean ocular perfusion pressure during pars plana vitrectomy may prevent surgically induced visual field defect, a surgeon told colleagues at the FLOREtina meeting in Florence, Italy.“Unexplained visual field loss after vitrectomy has been reported in up to 14% of patients,” Tommaso Rossi, MD, said.
Anti-complement C5 monotherapy ineffective in reducing geographic atrophy lesion size
MIAMI — An anti-complement C5 therapy had no different effect on geographic atrophy lesion size than sham therapy, according to a presentation at Angiogenesis, Exudation, and Degeneration 2016.“No efficacy was observed,” Parisa Zamiri, MD, PhD, said of the treatment drug LFG316 in her presentation on the drug’s 12-month safety and efficacy results.
Study: Transscleral diode cyclophotocoagulation lowers IOP, risk for adverse events
Sequential glaucoma drainage device implantation and transscleral diode cyclophotocoagulation both reduce IOP after failure of a primary drainage device, but cyclophotocoagulation may carry less risk for adverse events, according to a study.The retrosp…
Regeneron reports 46% increase in total revenue for year
Regeneron reported a year-end total revenue of $4.1 billion for 2015 compared with $2.8 billion in 2014, according to a company press release. The 46% increase was partially attributed to an increase in the company’s net profit from commercialization of Eylea (aflibercept, Regeneron) outside of the United States.
Publication Exclusive: Some ophthalmologists opt out of CMS reimbursement system, exclusively accept private pay
Faced with declining reimbursements, administrative burdens and legal concerns, some ophthalmologists have chosen to opt out of Medicare and private insurance and only accept private pay. Others receive reimbursement for basic procedures and charge pat…
Publication Exclusive: Monovision LASIK in nondominant eye provides good vision at all distances
Brock Magruder underwent a LASIK monovision procedure in just his nondominant eye at age 50.I have found with many latent hyperopic presbyopes that they will benefit even more with a small correction in the distance eye as well; however, Brock is waiti…
Publication Exclusive: Contact lens-assisted cross-linking treats corneal ectatic disorders in thin corneas
Collagen fibers in the human body are normally bonded together and stabilized by covalent cross-links. The tensile strength of mature collagen fibers is largely due to intermolecular covalent cross-links. Collagen cross-linking was described by Theo Seiler et al as a means to strengthen a weak and ectatic cornea. This works by utilizing ultraviolet A at a wavelength of 370 nm in the presence of the photosensitizer riboflavin to create an increased number of covalent bonds among corneal stromal collagen fibers.Riboflavin is a photosensitizer and causes damage at a lower UVA (Read more...)
Risk alleles for neovascular AMD may determine neovascularization in pachychoroid patients
MIAMI — The frequency of risk alleles predisposing to neovascularization in age-related macular degeneration also predicts neovascularization in pachychoroid disease, according to a study presented here. “The risk alleles investigated seem predisposed to the neovascularization, not necessarily just in AMD, but perhaps in other diseases such as pachychoroid,” K. Bailey Freund, MD, said at Angiogenesis, Exudation, and Degeneration 2016.
CMS extends 2015 EHR meaningful use attestation deadline
CMS has extended the deadline to attest to meaningful use of electronic health records for 2015, according to an email from the agency.Providers in the Medicare & Medicaid EHR Incentive Programs can now attest until March 11. The original deadline had been set as Feb. 29.