As the Right to Try Act of 2017 moves from Senate approval to the House floor, the FDA continues to facilitate expanded access to investigational drugs for terminally ill patients with streamlined case review and clarified instructions for adverse event reports.
“The Right to Try Act is an alternative pathway. I don’t think it’s necessarily there to replace the FDA Expanded Access program currently in place,” Neha K. Patel, PharmD, associate at Arnold & Porter Kaye Scholer LLP, told Healio.com/Hepatology. “There are pros and cons to having an individual patient (Read more...)
Author: Healio ophthalmology
Altered tissue percentage may not be risk for ectasia after LASIK
LISBON, Portugal — The currently recommended percentage of tissue altered did not demonstrate to be an independent risk factor for post-LASIK ectasia in a multicenter study.
Percentage of tissue altered (PTA) is a possible new risk factor for iatrogenic ectasia recently described by Marcony Santhiago, MD, and currently at the center of a hot debate among cornea and refractive surgery specialists.
“Santhiago did a great job trying to identify independent risk factors for iatrogenic ectasia, and he and his co-authors found in a large series of cases that eyes with (Read more...)
New phakic IOL offers solution for myopic presbyopes
LISBON, Portugal — A phakic posterior chamber IOL for presbyopia, now produced in Europe, shows favorable outcomes and offers a unique option to myopic presbyopes, according to one surgeon.
“The EyePCL (EyeOL UK) is a true revolution. Companies have been trying for a long time to develop a phakic lens for presbyopia, and now we have it. It can be implanted through a 1.8-mm microincision, is available in a wide range of powers, up to –20 D, and includes the toric option,” Pavel Stodulka, MD, PhD, said at the European (Read more...)
VIDEO: Once upon a time, there was just full thickness transplantation
LISBON, Portugal – At the European Society of Cataract and Refractive Surgeons meeting, Sadeer B. Hannush, MD, talks about the many different options that have developed in corneal transplantation in recent times.
AAO reports superior results of DMEK vs. DSEK
A report of the America Academy of Ophthalmology, based on extensive review of the literature, provided evidence that DMEK is a safe and effective procedure, superior to DSEK for visual recovery times, visual outcomes and rejection rate.
A total of 1,085 articles in English language were reviewed, of which 47 were relevant to assess the safety and efficacy of Descemet’s membrane endothelial keratoplasty (DMEK) vs. Descemet’s stripping endothelial keratoplasty (DSEK). The follow-up ranged between 5.3 and 68 months.
A better visual recovery was shown after DMEK than DSEK. When visual
FDA committee gives push forward for Aerie’s Rhopressa
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee voted favorably on questions of efficacy regarding Aerie Pharmaceuticals’ glaucoma drug Rhopressa.
Rhopressa (netarsudil ophthalmic solution 0.02%) is a once-daily eye drop designed to lower IOP in patients with open-angle glaucoma or ocular hypertension by targeting the trabecular meshwork.
The panel voted 10 yes, zero no and zero abstentions on the following question: Do the clinical trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle
Azura secures $16 million in Series B funding
Azura Ophthalmics has completed $16 million in Series B funding to advance development of a meibomian gland dysfunction treatment, according to a company press release.
The investment was led by a syndicate of OrbiMed, TPG Biotech and Brandon Capital’s Medical Research Commercialisation Fund and included participation from an existing investor, Ganot Capital.
“This latest round of financing validates the strength of our team’s accomplishments to date and will fuel Azura’s unique and innovative approach to treating dry eye,” Eugene de Juan, one of the company’s
New IOL design more tolerant to dislocation, pupil size
Mike P. Holzer
LISBON, Portugal — A new-concept multifocal IOL offers high tolerance for dislocation and pupil size, according to one speaker.
“Symmetric multifocal lenses can cause problems with quality of vision if not perfectly centered in the eye. The Precizon presbyopic IOL (Ophtec) has a sequential distribution of near and far segments over the optical surface, which maintains a 50-50 ratio also when the IOL is decentered and with different pupil sizes,” Mike P. Holzer, MD, said at the European Society of Cataract and Refractive Surgeons meeting.
The lens (Read more...)
Trump’s immigration demands leave DACA recipients, children at risk
In an effort to push extensive immigration reform, President Donald J. Trump issued a letter early this week to House of Representatives and Senate leaders along with a list of changes that “must be included as a part of any legislation addressing the status of Deferred Action for Childhood Arrivals recipients.”
This letter comes in the wake of last month’s statement in which Trump and Attorney General Jeff Sessions announced a 6-month plan to end DACA, which would impact nearly 800,000 immigrants between the age of 15 and 36 years (Read more...)
PanOptica secures $11 million in Series B financing
PanOptica has completed $11 million in Series B financing to clinically advance PAN-90806, its small molecule anti-VEGF eye drop for treating neovascular eye diseases, according to a press release.
The funding, provided by Third Rock Ventures and SV Health Investors, will allow the company to proceed with a phase 1/2 study of PAN-90806 as monotherapy for treatment of neovascular age-related macular degeneration.
“The additional Series B financing reflects our investors’ confidence in the potential of our new advanced-generation formulation of topical PAN-90806 and the direction of
FDA committee sees Spark’s retinal dystrophy gene therapy as having favorable benefit-risk profile
An FDA advisory committee voted unanimously that Spark Therapeutics’ Luxturna gene therapy for retinal dystrophy has an overall favorable benefit-risk profile.
Sixteen members of the Cellular, Tissue, and Gene Therapies Advisory Committee voted yes and zero voted no, with zero abstentions, on the following question: Considering the efficacy and safety information provided in the briefing document, as well as the presentations and discussions during the AC meeting, does voretigene neparvovec have an overall favorable benefit-risk profile for the treatment of patients with vision loss due
Executive order on health care promotes insurance access on a national scale
President Donald J. Trump has signed an executive order that he said would “expand choices and alternatives” to health insurance plans offered under the Affordable Care Act.
The executive order outlines several strategies designed to increase access to health insurance plans. First, it allows the secretary of labor to increase access to association health plans on a national scale, a move that would allow “American employers to form groups across state lines,” according to Trump. Under such expansion, less stringent interpretation of the Employee Retirement Income
FEMCAT study shows equal outcomes, success rates, complications for femto surgery and standard phaco
Cedric Schweitzer
LISBON, Portugal — The FEMCAT study, a large, real-life, prospective, multicenter study comparing femtosecond laser cataract surgery and phacoemulsification, showed equal results and complications between the two procedures.
“We did not observe any specific issue related to the laser procedure, we did not observe any statistical difference between femto and phaco for all outcome measures, and whatever small difference was found is far beyond any clinical significance for the patient,” Cedric Schweitzer, MD, said at the European Society of Cataract and
Three botulinum neuromodulators efficacious in facial synkinesis
AbobotulinumtoxinA, onabotulinumtoxinA and incobotulinumtoxinA were associated with similar efficacy in facial synkinesis within 4 weeks of treatment.The current single-blind randomized clinical trial included 28 patients treated at a single center in …
KalVista, Merck to collaborate on development of DME treatment
Merck will continue development of KalVista Pharmaceuticals’ investigative diabetic macular edema drug KVD001, according to a KalVista press release.
Merck will receive certain rights, including an option to acquire intravitreal KVD001 after a phase 2 proof-of-concept trial, under the terms of the agreement. KalVista will also grant Merck similar options for investigational orally delivered molecules for DME that KalVista will continue to develop, the release said.
Merck will pay a $37 million upfront fee, and KalVista will be eligible to receive payments up to $715 million depending on
Long-term outcomes of posterior optic capture show advantages in young children
Vaishali Vasavada
LISBON, Portugal — Posterior optic capture, whenever possible, is an alternative technique that can avoid vitrectomy as well as visual axis obscuration even in children younger than 4 years, according to one speaker.
“In-the-bag implantation with [posterior continuous curvilinear capsulorrhexis] and anterior vitrectomy is today the standard of care for children younger than 3 to 4 years. However, vitrectomy at this young age increases the risk of glaucoma and affects growth. You enter in the pars plana region that is not yet fully developed at this age,”
Good results seen in pilot study of stromal enhancement technique in patients with advanced keratoconus
Jorge Alió del Barrio
LISBON, Portugal — Minimally invasive transplantation of a thin lamina of decellularized stroma, with or without the addition of autologous mesenchymal stem cells, might benefit eyes with advanced keratoconus, improving vision and delaying the need for more invasive graft surgery.
At the EuCornea meeting, Jorge Alió del Barrio, MD, presented the results of a pilot study in which nine patients with advanced keratoconus were implanted with human decellularized donor femto-dissected 120 µm thick corneal stroma grafts, with or without the addition of
Vector planning can reduce residual astigmatism in refractive surgery
LISBON, Portugal ― At the European Society of Cataract and Refractive Surgeons meeting here, George Stamatelatos, BScOptom, discusses how the use of vector planning may reduce residual astigmatism in refractive surgery.
Medically injured patients desire to know more about prevention efforts
Although 60% of patients and family members were satisfied with communication-and-resolution programs after medical injury, their need to be heard and to know about efforts to prevent recurrences often were unmet, according to findings published in JAMA Internal Medicine.
“The misery of medical malpractice litigation for all involved has made hospitals keenly interested in resolving medical injuries with patients before claims are filed,” Jennifer Moore, LLB, MA, PhD, of the University of New South Wales in Sydney, Australia, and colleagues wrote. “Among the strategies
Haag-Streit introduces Eyestar 900 OCT
Haag-Streit announced a new OCT device and an update to its EyeSuite software at the European Society of Cataract and Refractive Surgeons meeting in Lisbon, Portugal.Eyestar 900, a swept source OCT device, delivers elevation-based topography maps of th…