STAAR Surgical’s Visian Toric Implantable Collamer Lens has been approved by the FDA for the correction of myopia with astigmatism, according to a company press release.The approval expands the company’s ICL indications, the release said.“FDA’s approva…
Author: Healio ophthalmology
EyePoint posts net loss for fourth quarter, full year
EyePoint Pharmaceuticals reported a net loss of $34.4 million, or $0.62 per share, in its fourth quarter compared with a net loss of $6.1 million, or $0.16 per share, in the fourth quarter a year ago.For the full fiscal year, which ended June 30, the c…
FDA to review Eylea for diabetic retinopathy
The FDA has agreed to review a supplemental biologics license application of Eylea for the treatment of diabetic retinopathy, Regeneron announced in a press release.Data from the phase 3 PANORAMA trial found positive top-line results for Eylea (afliber…
Eyevance acquires FreshKote drops
Eyevance Pharmaceuticals announced it has acquired the FreshKote line of lubricant eye drops from Focus Laboratories, according to a press release.The acquisition includes all of the FreshKote formulations, including the preservative-free multidose bot…
Visual recovery possible after eye injuries from hand-held laser pointers
Commercial hand-held laser pointers can inflict macular injuries, but good visual recovery is possible.A study included eight eyes of seven patients who reported injuries after exposure to laser pointers. Five of the injuries were accidentally self-inf…
Alcon adds ultraviolet-absorbing IOLs
Alcon is introducing multifocal and multifocal toric ultraviolet-absorbing IOLs to the AcrySof portfolio, as well as the AcrySof UV-absorbing monofocal IOL with the UltraSert pre-loaded delivery system, the company announced in a press release.The new …
Apellis begins phase 3 clinical program for geographic atrophy treatment
A two-trial phase 3 clinical program for APL-2 for geographic atrophy has begun with the first patient enrolled in the DERBY trial and the first patient dosed in the OAKS trial, Apellis Pharmaceuticals announced in a press release.The two-trial prospec…
AGTC releases fourth quarter, year-end financial results
Applied Genetic Technologies Corporation reported a net loss of $6.6 million for the fourth quarter of the 2018 fiscal year compared with a net loss of $3.2 million in 2017’s fourth quarter.For the year, the company posted a net loss of $21.3 million c…
Alcon global headquarters to be in Geneva
Alcon’s global headquarters will be located in Geneva after the proposed spinoff from Novartis is complete, the company announced in a press release.
The office complex will house the company’s senior corporate leadership and other corporate and commercial functions, the release said. Alcon’s Europe, Middle East and Africa regional office is already based in the city.
“For more than 40 years, Alcon has had a significant presence in Switzerland, which is known for its progressive business climate and innovation-friendly policies. Being headquartered in Geneva will help
ICD-10 additions affect ophthalmology diagnosis codes
Distinction between upper and lower eyelids of right and left eyes has been added to a number of malignant and benign neoplasm ICD-10 codes, according to the American Society of Ophthalmic Administrators, which released a list of fiscal year 2019 code …
RSA starts pay-it-forward refractive surgery training program
The Refractive Surgery Alliance is creating a new training program for vision correction surgeons that will allow fellows to train at multiple sites, the organization announced in a press release.
Incorporating a network of training sites, the program will allow participants to train at their home site for 9 months and rotate through other network sites for up to 3 months per year during the 2-year curriculum.
Fellows will receive a six-figure salary and other benefits during the program and will serve a 3-year commitment at an RSA-affiliated practice after (Read more...)
Smartphone photoscreening app for amblyopia consistent with screening technology
Smartphone photoscreening for amblyopia in pediatric patients using the GoCheck Kids application had positive predictive value comparable with other commercial objective screeners.
Ten pediatricians in four practices used Nokia 1020 smartphones with single-axis Gobiquity software. The pediatricians completed 6,310 in-office screenings, resulting in a referral rate of 5%; 25% were referred for high anisometropia, 31% for hyperopia and 15% for myopia.
Of the 332 patients who did not pass the screening and were referred, 217 (65%) were followed up by the study authors.
“The [positive
Allergan announces second quarter financial results
Allergan reported a GAAP operating loss of $467 million, or $1.39 per share, in the second quarter of 2018 and a non-GAAP operating income of $1.97 billion, or $4.42 per share, an increase of 4.6% from 2017’s second quarter, according to a press release.
Net revenues were $4.124 billion compared with $4.007 billion a year ago.
The company’s total GAAP operating expenses decreased 14.9% to $1.19 billion for the quarter, while its non-GAAP expenses decreased from $1.22 billion in 2017’s second quarter to $1.13 billion. GAAP research and development costs (Read more...)
Retinal alterations noted in preclinical Alzheimer’s disease
Rajendra S. Apte
Subjects with preclinical Alzheimer’s disease had a larger foveal avascular zone and decreased inner foveal thickness compared with subjects without preclinical Alzheimer’s disease.
The case-controlled study included 58 eyes from 30 participants who underwent positron emission tomography and/or cerebral spinal fluid testing to determine biomarker status. Measurements such as retinal nerve fiber layer thickness, inner and outer foveal thickness, and foveal avascular zone were taken with OCT angiography (OCTA).
Researchers evaluated the OCTA measurements to determine
Eyenovia posts quarterly loss
Eyenovia reported a net loss of $3.3 million, or $0.33 per share, in 2018’s second quarter compared with a $1 million net loss, or $0.43 per share, in the same time period of 2017.
General and administrative costs increased from $0.2 million to $0.9 million in the quarter, while research and development costs increased from $0.8 million to $2.4 million, according to a press release.
Total operating expenses rose 240% to $3.3 million from $1 million.
The company had a cash balance of $24.6 million as of June 30.
OSN’s top news of the week
Here are some of the top stories of the past week on Healio.com/OSN:
BCVA improves in second decade despite muscle surgery in children with albinism
Extraocular muscle surgery done in children with albinism in the second decade of life did not affect improvement in best corrected visual acuity, which typically improves in these patients during that period regardless of surgery. Read more.
EyeGate reports EGP-437 did not demonstrate non-inferiority to control group
EyeGate Pharmaceuticals announced the top-line results for a phase 3 trial of EGP-437 for the treatment (Read more...)
CyPass recall tops August ophthalmology news
Alcon’s decision to voluntarily recall its CyPass micro-stent from the global market was the most-read article on Healio.com/OSN in August.
Here are the month’s top five stories:
Alcon calls for surgeons to stop implanting CyPass micro-stent
According to a company press release, the decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone. Read
Practical pearls in pediatric vitreoretinal surgery
Pediatric retina surgery is not for the faint of heart. The stakes could not be higher for the youngest of our patients, and the margin between success and failure is razor thin. In surgery, as in medicine, small innovations and stepwise refinements to…
Shire posts increase in quarterly income
Shire reported a net income of $616 million in the second quarter of 2018, an increase of 156%, according to a press release.
Product sales grew by 6% in the quarter to $3.8 billion, led by immunology, internal medicine and ophthalmic products, the release said.
Shire’s board agreed in the second quarter to allow the company to be acquired by Takeda, a plan that is expected to close in the first half of 2019.
Past rulings may provide insight on how Supreme Court nominee Kavanaugh may impact health care
The Senate Judiciary Committee began hearings this week for Supreme Court nominee Brett Kavanaugh. The former Supreme Court law clerk and presidential staff member received the American Bar Association committee’s highest rating of “well-qualified,” which the association said is not based on philosophy or political ideology.
A review of his rulings in past cases as well as statements he has made may provide some idea on how his judicial philosophy could impact several health care and public health issues likely to reach the Supreme Court in the near future, several (Read more...)