Author: Healio ophthalmology

Societies encouraged by spirit of CMS’ proposed changes, question efficacy

CMS’s suggestions to modernize Medicare with the intention of restoring the doctor-patient relationship — a broad, wide-reaching initiative the agency stated was historic and has dubbed “Patients Over Paperwork” — were met with general optimism from several medical societies, who also noted further steps that should be taken.
According to a press release, CMS’ proposal calls for:
“[These] reforms proposed by CMS bring us one step closer to a modern health care system that delivers better care for Americans at a lower cost,” Alex Azar, HHS

Novel antibody yields significant VA gains in DME

Rishi P. Singh
VANCOUVER, British Columbia — RG7716, a bispecific antibody designed for intraocular use, resulted in statistically significant visual acuity gains in patients with treatment-naive diabetic macular edema compared with anti-VEGF monotherapy, according to the results of a study presented here.
“Primary endpoints of both 10-letter and 15-letter gains in visual acuity favored the RG7716 group over the anti-VEGF monotherapy group. In addition, it showed improvements in both achieving a dry retina, as well as the two-step retinopathy score improvements in the study,”

Near VA improves with topical presbyopia treatment

The PRX ophthalmic solution from Presbyopia Therapies LLC demonstrated a statistically significant three line or greater improvement in monocular distance corrected near visual acuity in a phase 2b trial, meeting primary efficacy and safety endpoints, the company announced in a press release.
Conducted by Ora Inc., the randomized, double-masked, placebo-controlled study enrolled 58 patients between the ages of 48 and 64 years and evaluated two unique miotic-based PRX test candidates, the release said.
One hour after instillation, 47.2% of study eyes gained at least three lines (P

Doctors concerned after HHS-funded website shuts down

Alan Dow Jennifer Caudle
The National Guideline Clearinghouse website — the online tool that the Agency for Healthcare Research and Quality said provided information on clinical practice guidelines — went dark earlier this month.
Clinicians expressed dismay at the news, saying shutting down the website takes away an objective, one-stop shop for clinical guidelines.
“The great thing about the National Guideline Clearinghouse was that it was being funded by the federal government, so you knew it was representing the interests of the public, whereas a lot of the other resources

Early morning sun gazing ritual in India may cause chronic solar retinopathy

Shaileen Parikh  
VANCOUVER, British Columbia — The early morning religious ritual of sun gazing may be causing patients in India to experience chronic solar retinopathy with macular changes and a decrease in visual acuity, according to a speaker here.
“Sun gazing as a ritual can cause chronic solar retinopathy. Macular changes on OCT and fundus are very characteristic. Any person with these characteristic macular changes should always be asked about sun gazing,” Shaileen Parikh, MS, DO, FMRF, said at the American Society of Retina Specialists annual meeting.
The

Triamcinolone injection at end of retinal surgery may be alternative to steroid drops

Elizabeth A. Atchison  
VANCOUVER, British Columbia — A single subconjunctival 4 mg triamcinolone injection after retinal surgery had comparable IOP and inflammatory outcomes as a subconjunctival 1 mg dexamethasone injection and a 4- to 6-week steroid taper, according to a speaker here.
“It is reasonable for retinal surgeons to consider freeing their patients from the traditional drop taper and instead using a single subconjunctival injection [of triamcinolone] at the end of the case,” Elizabeth A. Atchison, MD, said at the American Society of Retina Specialists annual

Biosimilars for bevacizumab and ranibizumab show promise for retinal diseases

VANCOUVER, British Columbia — Data for two new biosimilars for ranibizumab and bevacizumab, currently available in India, show the treatments are safe and effective for a variety of retinal diseases, according to a speaker here.
“Our data confirms that both these biosimilars are effective and safe. These could become the new safe, low-cost therapies for retinal diseases in the future,” Alay S. Banker, MD, said at the American Society of Retina Specialists annual meeting.
The prospective, consecutive case series included 22,276 eyes that received Razumab (Intas Pharmaceutical),

Syringes in certain Eylea kit lots related to intraocular inflammation

VANCOUVER, British Columbia — Four of 29 Eylea kit lots were associated with 62% of cases of sterile intraocular inflammation following injection that were reported to the American Society of Retina Specialists Research and Safety in Therapeutics Committee, according to the results of a retrospective study.
The review included 92 eyes of 88 patients who experienced inflammation after an Eylea (aflibercept, Regeneron) injection and were voluntarily reported to ASRS by 15 practices throughout the United States from Jan. 7, 2017, to Jan. 19, 2018.
“With regard to clustering of cases,

Appellate court rules against Allergan’s tribal license patent protection deal

The U.S. Court of Appeals for the Federal Circuit has struck down Allergan’s attempt to use tribal sovereignty to avoid a patent challenge on Restasis.
The court affirmed a U.S. Patent Trial and Appeal Board decision that tribal sovereign immunity does not apply to inter partes review proceedings.
Allergan entered a deal with the Saint Regis Mohawk tribe in 2017 in an attempt to protect its patents for the dry eye treatment Restasis (cyclosporine ophthalmic emulsion 0.05%). Six of the patents associated with Restasis were transferred to the tribe in (Read more...)

Positive phase 2 results reported for implantable wet AMD treatment

An investigational port delivery system with ranibizumab showed positive phase 2 results in patients with wet age-related macular degeneration, according to a Genentech press release.
The multicenter, randomized, interventional, active treatment-controlled LADDER study evaluated the efficacy and safety of the port delivery system (PDS), a small, refillable eye implant that continuously delivers  ranibizumab over time, in 243 patients.
Those who had the PDS implanted received one of three ranibizumab concentrations, 10 mg/mL, 40 mg/mL or 100 mg/mL, the release said. Approximately 80% of