Retinal Physician

JAN-FEB 2017

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8 R E T I N A L P H Y S I C I A N . C O M | O C T O B E R 2 0 1 6 SUBSPECIALTY NEWS R E T I N A L P H Y S I C I A N | J A N U A R Y / F E B R U A R Y 2 0 1 7 8 n A CMS "demonstration plan" that would have rewarded physicians for administering less costly Medicare Part B drugs and penalized them for using their more costly counterparts looks to have withered on the decimated Democratic vine following Donald Trump's election victory. Spokespersons for ophthalmic and oncologic organizations, the two spe- cialties that would have felt the plan's financial impact the most, said the Obama administration's willingness to let a key, late November deadline pass without taking any action clearly sig- naled that the administration has con- ceded the battle. CMS received more than 1,300 public comments after the plan was announced in March, with the overwhelming majority opposed to implementation. Cathy Cohen, AAO vice presi- dent for governmental affairs, said the Obama administration had proffered the demonstration plan without con- sulting with representatives of those medical specialties that would be most affected, thus creating widespread oppo- sition to what the AAO considered a flawed and ill-informed plan. During the public comment period, the AAO, ASCRS, and the Retina Society published a joint letter to CMS pointing out that retina specialists would almost certainly lose money on every injection of Lucentis (Genentech) and Eylea (Regeneron) if the lower pro- posed reimbursement amounts were put into effect. e reimbursement formula recommended by CMS would not have covered the overhead for pro- curing, storing, administering, tracking, and applying for reimbursement for the two leading FDA-approved anti-VEGF drugs, the letter said. Trump's Win Scuttles CMS Reimbursement Plan Payment for Lucentis and Eylea were at risk. IN BRIEF n Genentech drug combats GCA in phase 3 The Genentech drug Actemra met both its primary and secondary endpoints in treating giant cell arteri- tis (GCA) — a form of vasculitis that can lead to blindness — in recently released data from a 251-patient phase 3 study. The prevalence of GCA has been estimated at over 200 per 100,000 persons in the US over the age of 50, and the disease is two to three times more likely to affect women than men. At one year, 56% of patients on Actemra achieved disease-free remis- sion, while 14% of patients on a steroid-only taper regimen were dis- ease-free at six months. Actemra was given "breakthrough" status for GCA by the FDA in October. It is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheu- matoid arthritis who have used one or more disease-modifying anti-rheu- matic drugs such as methotrexate, that did not provide enough relief. n Sustained-release format planned for Eylea Regeneron (Tarrytown, NY) will collaborate with Ocular Therapeutix (Bedford, MA) in the development of sustained-release delivery of its anti- VEGF drug Eylea (aflibercept), which is now delivered by intravitreal injection. Ocular Therapeutix is now devel- oping proprietary sustained-release hydrogel-based drug delivery depots that can be implanted and formulated with both small and large molecule pharmaceuticals, such as tyrosine kinase inhibitors and protein-based anti-VEGFs, respectively, with the goal of delivering sustained and therapeu- tic levels of drugs to targeted ocular tissues. The formulation for Eylea is in preclinical development. Genentech's Lucentis, the only other FDA-approved anti-VEGF for reti- nal disease, has been in clinical trials for sustained-release delivery for more than two years. The current phase 2 trial, called LADDER, encompasses 316 patients and employs a refillable implant. n Study: lopidine reduces pain from intravitreal injections Edith Wolfson Medical Center researchers in Israel found that topical apraclonidine (Iopidine) applied 30 minutes before an intravitreal injection reduces patients' perception of pain from the injection. In a 39-patient study of patients receiving bevacizumab, patients receiv- ing Iopidine reported a mean score of 1.69 on a numerical pain scale (1 being the least pain) while the same patients receiving placebo on a different visit reported a mean score of 3.28. A reduc- tion in the incidence and size of injection- related subconjunctival hemorrhage was also reported in some patients. Iopidine is generally used as an adjunct therapy to help reduce IOP in patients having laser therapy to treat glaucoma. The study appeared online in Retina.

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