In a phase 3 trial, tocilizumab showed positive phase 3 trial results for patients with giant cell arteritis.“The publication of these phase 3 results in The New England Journal of Medicine validates the significance of our considerable basic and clinical autoimmune disease research in medical practice,” Sandra Horning, MD, chief medical officer and head of Global Product Development, said in a press release from Genentech. “The data from the GiACTA supported the FDA approval of the first new treatment option for patients with [giant cell arteritis] GCA in more than (Read more...)
Author: Healio ophthalmology
FDA clears Quantel for laser system to treat retinal diseases
The FDA has granted Quantel Medical 510(k) market clearance for the Easyret 577 nm yellow photocoagulator, which is used to treat certain forms of macular edema and peripheral retinal pathologies.The photocoagulator can be set to treat a single spot or…
Latest Iluvien data similar to trial results
Patients with chronic diabetic macular edema treated with an Iluvien implant experienced an average visual acuity increase from 51.9 letters at baseline to 57.2 letters at 24-month follow-up, with IOP-related adverse events occurring at a similar frequency as those reported in the FAME study.Fourteen United Kingdom clinics contributed data comparing real-world safety and visual function outcomes in eyes treated with an Iluvien implant (0.2µg per day fluocinolone acetonide, Alimera Sciences). Three hundred forty-five eyes of 305 patients with chronic DME had a mean follow-up of 428 days.
Santen initiates phase 2a study of DE-122 for wet AMD
Santen has initiated a phase 2a clinical study of the efficacy and safety of intravitreal injections of DE-122 for the treatment of wet age-related macular degeneration, according to a joint press release from Santen and Tracon Pharmaceuticals.The rand…
PUBLICATION EXCLUSIVE: The state of dry eye care, part 2
As we head into the summer months, I thought it would be helpful to take the pulse of our dry eye world and report on the state of the state, if you will. In part 1 I reviewed how we are diagnosing dry eye in our clinics — and learned that the news cycle does not respect the editorial/creative process when RPS sold InflammaDry while my piece was in turnaround. Let us now examine the state of dry eye disease treatment.As a group, doctors who treat DED have become much (Read more...)
Ozurdex implant tolerated well, with IOP spikes transient and treatable
A retrospective real-life study of patients treated with the Ozurdex dexamethasone implant for various indications showed overall good tolerance and provided useful information on risk factors for pressure elevation.Four hundred twenty-one eyes of 361 …
4D Molecular Therapeutics teams with Foundation Fighting Blindness to develop gene therapies
4D Molecular Therapeutics announced a partnership with Foundation Fighting Blindness to develop intravitreal gene therapeutics for patients with inherited retinal degenerations and dry age-related macular degeneration. 4D Molecular Therapeutics will pr…
ASCRS, ASOA representatives meet with Congress members at annual fly-in
About 50 physicians and ophthalmic administrators representing the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators met with members of Congress in Washington to discuss the need to repeal the Independent Payment Advisory Board and the need for regulatory relief for physicians and other care providers from several specific program requirements, according to an ASCRS press release. The representatives met with Congress through the annual Alliance of Specialty Medicine Legislative Fly-In, with a total of 135 physicians and practice administrators participating. According to an (Read more...)
Allegro Ophthalmics receives $10.7 million in private financing
Allegro Ophthalmics announced it has secured $10.7 million in a private round of equity financing. The additional capital will allow the company to complete several phase 2 clinical trials and help prepare for phase 3 studies in the future, Vicken Kara…
New definition of dry eye disease recognizes its multifactorial nature
The TFOS DEWS II membership acknowledged the need to recognize the multifactorial nature of dry eye disease, which has led to a refined definition of the disease, wherein loss of homeostasis of the tear film is the central pathophysiological concept.A …
Women in Ophthalmology Summer Symposium to focus on leadership
The annual Women in Ophthalmology Summer Symposium will take place in San Diego from Aug. 10 to 13 with a restructured format, new content and more networking opportunities, meeting chair Lisa Nijm, MD, JD, told Healio.com/OSN. With more than 300 atten…
Patients report satisfaction with bifocal enhanced depth of focus IOL
Patients reported satisfaction with distance and intermediate vision after implantation of a new shape-segmented enhanced depth of focus IOL. In a study performed at Ludwig-Maximilians University of Munich, Germany, 22 patients between the ages of 55 a…
PUBLICATION EXCLUSIVE: Man presents with blurry vision, flashes, floaters and redness
A 53-year-old Caucasian man presented with a 3-week history of worsening blurry vision of the left eye associated with flashes, floaters and redness. He also complained of a recent fever that lasted 2 weeks and resolved on its own. He noted that he recently had a “sore” in his mouth that also resolved.The patient had a medical history of hypertension and hyperlipidemia. His ocular history was significant only for refractive error. He denied any tobacco use and reported social alcohol use. He had no pets at home. He worked as (Read more...)
Top five videos from OCTANe
The OCTANe Ophthalmology Technology Summit, held in Newport Beach, California, in June, gave experts a forum to discuss new technology and business opportunities in the field of ophthalmology.Healio.com/OSN was there to provide live coverage, including…
YAG laser vitreolysis improves symptomatic vitreous floaters
YAG laser vitreolysis was associated with a better improvement in vitreous floater symptoms than a sham procedure, according to study findings.Researchers conducted a masked, sham-controlled, randomized clinical trial in 52 eyes of 52 patients. The stu…
Cenegermin eye drops approved in Europe for neurotrophic keratitis
Cenegermin eye drops received marketing authorization from the European Commission for the treatment of neurotrophic keratitis. This is the first biotechnological treatment available for moderate to severe neurotrophic keratitis, according to a press release from Dompé.
PUBLICATION EXCLUSIVE: Descemet’s membrane endothelial keratoplasty slowly on the rise
Lamellar techniques have almost entirely replaced penetrating keratoplasty. They have undergone progressive refinements and have more recently evolved toward minimizing the presence of allogenic tissue in the eye to prevent rejection and graft failure.“Overall, if we can work toward smaller grafts or no graft at all, this is going to benefit the patient in many ways. On the other hand, if we can multiply the number of grafts we can obtain from the same donor, we can reduce the costs and the problem of tissue shortage in some areas of (Read more...)
Alimera allowed to reduce size of Iluvien study in UK
The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has given final approval to reduce the size of Alimera Sciences’ post-marketing study of Iluvien, according to a company press release.The study, originally intended to follow 800 patients over 5 years, has shown consistent positive safety data, leading the company to seek a smaller sample size, the release said. There are currently 550 patients enrolled.
Voretigene neparvovec receives rare pediatric disease designation from FDA
The FDA offices of Orphan Products Development and Pediatric Therapeutics have designated voretigene neparvovec as a drug for a rare pediatric disease, according to a Spark Therapeutics press release.Voretigene neparvovec, which will be marketed under …
Akorn shareholders approve Fresenius Kabi merger
Akorn shareholders have approved a merger with Fresenius Kabi, according to an Akorn press release.Fresenius Kabi announced in April that it would acquire the company for $4.3 billion, or $34 per share. The agreement allowed for $450 million in debt to…