Drug Pipeline for Macular Degeneration in Focus at AAO

Laird Harrison

October 19, 2018

CHICAGO — New treatments for neovascular age-related macular degeneration and innovations in refractive surgery techniques will figure prominently at the American Academy of Ophthalmology (AAO) 2018 Annual Meeting.

"The meeting is filled with information on how to manage problems," said William Fishkind, MD, from the University of Arizona in Tucson, who is associate secretary for the annual meeting program.

"I think that's the crux," he Medscape Medical News.

But not all the problems that will be discussed are clinical. Both drug prices and sexual harassment in the field of ophthalmology are on the agenda.

Treatments for neovascular age-related macular degeneration continue to flow through the pipeline, and studies on several of these will be presented at the meeting.

VEGF Inhibitors

For example, 2-year results from two phase 3 trials — HAWK and HARRIER — of brolucizumab, a new vascular endothelial growth factor (VEGF) inhibitor from Novartis, will be presented by Pravin Dugel, MD, from the Keck School of Medicine in Los Angeles and Retinal Consultants of Arizona.

One-year results from HAWK and HARRIER showed that intravitreal injections every 12 weeks were sufficient for many patients and that brolucizumab is comparable to bimonthly aflibercept (Eylea, Regeneron).

Abicipar, a second-generation drug with the potential for 12-week treatment intervals, will also get a hearing. Abicipar is a DARPin-based agent that binds to both VEGF and platelet-derived growth factor receptors.

In phase 3 results reported in July by the drug's developers — Molecular Partners and Allergan — abicipar administered every 12 weeks was comparable to ranibizumab administered every 4 weeks. However, rates of inflammation were much higher with abicipar.

"It will be interesting to know why the inflammation rate is that high," Dugel told Medscape Medical News.

Meanwhile, Roche is betting on faricimab, a bispecific antibody that simultaneously binds to and neutralizes both angiopoietin-2 (Ang-2) and VEGF factor A. Researchers will present phase 2 results.

An even more novel approach to the treatment of neovascular age-related macular degeneration will be examined during a late-breaker session. Results will be presented from a phase 1 study designed to determine whether a single intravitreal injection of RGX-314, a gene therapy developed by Regenxbio, will induce the production of anti-VEGF antibodies, eliminating the need for more injections.

We haven't established which of the corneal refractive procedures is the best way to go.

Five-year results from a comparison of small-incision lenticule extraction (SMILE) and femtosecond LASIK will highlight innovations in cataract and refractive surgery.

"I think there will be a lot of discussion about SMILE because it's still an up-and-coming procedure and we haven't established which of the corneal refractive procedures is the best way to go," said Fishkind.

He said he is looking forward to a presentation examining the effect two treatments — ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK) — on visual acuity and endothelial cell loss.

"The grafts are getting thinner and thinner," said Fishkind. "The thinner they are, the harder they are to work with and the quicker they spread out. I think this is a subject we're going to see more of."

Glaucoma specialists, too, will find useful information at the meeting, such as results from a pivotal trial of the second-generation iStent inject from Glaukos.

It was a "big deal" when the first-generation iStent inject was approved, "but it's not great," Fishkind explained. "The big question is: How will the second generation work?"

Professional Issues

Not all the presentations will focus on clinical results. In one, researchers will report on a survey designed to gauge the extent to which ophthalmologists experience sexual harassment during training and practice.

"You know this is an issue," said Andrew Iwach, MD, from the Glaucoma Center of San Francisco, who is a clinical spokesperson for the AAO. "It is something we haven't talked about in ophthalmology much."

In another presentation, researchers compare the prices of three injectable and 27 topical ophthalmic drugs in Canada, Italy, Japan, Spain, Turkey, and the United States.

"They look at the influence of governments and the impact on drug prices," said Iwach. "I think it's important to look at the numbers and be aware of them."

Fishkind reports financial relationships with Bausch + Lomb and Johnson & Johnson. Dugel reports relationships with 44 medical companies and has stock ownership in Clearside Bomedical, Digisight, Aerpio, Alimera, Annidis, Macusight, Ophthotech, PanOptica, and TrueVision. Iwach has disclosed no relevant financial relationships.

Follow Medscape on Twitter @Medscape and Laird Harrison @LairdH


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