Retinal Physician

JAN-FEB 2017

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12 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 12 n e decade-long dominance of anti- VEGF monotherapy for the treatment of a range of retinal diseases will soon end if several drugs and drug combina- tions now in late-stage trials can live up to the potential they have shown in ear- lier studies. "Anti-VEGF monotherapy is reach- ing its limits," says Anthony P. Adamis, MD, global head of ophthalmology, immunology, and infectious diseases for Genentech. "But more people are doing research in eye disease than ever before. at is great for patients because compe- tition drives us all to do better." Dr. Adamis' comments are borne out by recently reported research advances. In the past year, several investigational drugs and drug combinations have dem- onstrated in later-stage studies that they can be dosed every 12 weeks with com- parative effectiveness to approved anti- VEGF therapies that are generally dosed every four to eight weeks. In addition, recent stepped-up efforts to develop dependable sustained-release delivery methods for suitable retina drugs by companies such as Genentech/ Roche, Regeneron, Alcon, and pSivida offer the promise of much longer time periods between retreatments. For example, Genentech/Roche has initi- ated a 316-patient phase 2 study called LADDER that is testing the ability of a refillable implant to deliver ranibizumab (Lucentis) in a sustained-release format. With regard to the investigational drugs and combos now in the pipeline, at least three have shown the potential — if approved — of a more durable response that should translate to less frequent dos- ing regimens that would ease the treat- ment burden on both patients and retina specialists. All three are either in phase 3 clinical trials or set to enter phase 3 in the near future. ese include Alcon's brolucizumab (RTH258), a small-molecule, single- chain antibody fragment that appears highly suitable for sustained-release delivery; Allegro's Luminate, which recently showed 12-week durability in the phase 2b DEL MAR study for DME; and Allergan's abicipar pegol (DARPin), which demonstrated eight- to-twelve week durability in the PALM2 trial. Add to these the promising Genentech/Roche bispecific antibody RG7716, currently in the 271-patient phase 2 AVENUE study for AMD and the 150-patient phase 2 BOULEVARD study for DME. RG7716 is both an anti-VEGF and an ANG2 inhibitor. It has shown good efficacy and durability in a small phase 1 trial in which the patient base was com- prised of poor responders to anti-VEGF monotherapy. In addition, Regeneron is studying an Eylea/anti-ANG2 combination, also in phase 2, which the company says has produced highly encouraging results in early studies. More Durable Retina Drugs in the Pipeline Twelve-week dosing now a realistic goal. IN BRIEF n Opsis to focus on cell-based ret- ina therapies Cellular Dynamics (CDI, Madison, WI), a developer and manu- facturer of induced pluripotent stem cell (iPSC) products, has a new venture, Opsis Therapeutics, focused on discov- ering and developing novel medicines to treat patients with retinal diseases. CDI says the Opsis Therapeutics team brings a track record of developing breakthrough technologies and building next-generation cell therapeutic pro- grams. The venture has been founded in partnership with David Gamm, MD, PhD, a pioneer in the differentiation and transplantation of iPSC-derived retinal cells. "No therapeutic options [are] available that can broadly mitigate or restore the permanent loss of vision and blindness [which inherited and acquired condi- tions] can cause," said Dr. Gamm in a statement. "At Opsis Therapeutics, we see promise in a variety of new approaches. For example, over the past decade, it has become feasible to gen- erate new photoreceptors from [iPSCs] and transplant them into the diseased retina, with additional advances antici- pated in the future." n FDA clears Navilas all-digital laser OD-OS (Irvine, CA) Navilas said the FDA has granted 510(k) clearance and immediate US commercial avail- ability of the Navilas 577s, a compact all-digital system for navigated focal and peripheral laser treatments. Navilas 577s enables physicians to digitally pre-plan the entire laser therapy on fundus images as well as external diagnostic images and pre- cisely execute this therapy plan under computer guidance. RP

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