2023 Retina Pipeline: A View Into Ongoing Innovation

2023 Retina Pipeline: A View Into Ongoing Innovation [Interactive]

Biosimilars are on the horizon.

Content guidance and source: Peter K. Kaiser, MD; Marielle Mahan, MD

Download the Pipeline PDFs

This content originally ran as a poster in the November/December issue. Check out the print publication to view the full size poster, or use the links below to download the PDFs.

Dry AMD Pipeline PDF Wet AMD Pipeline PDF

Watch as Peter K. Kaiser, MD, explains the poster and follow along with the graphics below.

The most recent edition of our poster tracking drug candidates and approved treatments for neovascular age-related macular degeneration (wet AMD), dry AMD, and geographic atrophy (GA) contains a number of changes from the previous iteration—and yet, much of the poster may resemble last year's version at first glance. A keen eye is needed to spot the differences. Let us point you in the right direction.

On the side of the poster highlighting developments in wet AMD, you'll notice an expanded list of anti-VEGF and anti-PlGF agents, including multiple biosimilars. As we move toward the age of biosimilar therapy, we thought it was best to highlight which biosimilars reference which molecules and which biosimilars have achieved approval status. For those who need a refresher course on biosimilars, refer to the box labeled "The Cutting Edge," where a biosimilar fact sheet has been assembled for your reference.

The portion of the poster outlining developments in dry AMD and GA has undergone significant expansion with the addition of several drugs that target the complement pathway in an effort to suppress inflammation. More than a dozen treatments in the dry AMD and GA space, many of them related to the complement pathway, have been added or subtracted from last year's poster. We've organized them (as best we could) by their specific complement pathway target, and provided a numbered reference so that readers can see precisely where a drug candidate fits into the complement cascade. For example, a number 4 is encased in a bubble near ANX007 (Annexon), the fourth drug on our list. To the left, an identical number 4 bubble can be seen at the top of the classical pathway, as this is where the C1q inhibitor ANX007 impedes the complement pathway.

One significant difference between the wet AMD and the dry AMD/GA summaries: the former has a series of "FDA-Approved" badges, while the latter remains filled with unapproved therapies. At the time of publication, no therapy for dry AMD or GA is approved by the US FDA. We expect that next year's poster might depict some "FDA-Approved" badges on the dry AMD and GA side of the poster—assuming, of course, that the FDA agrees that the findings of various phase 3 studies are sufficient for approval.

Share this year's interactive digital poster with your colleagues and mentees.

The Cutting Edge

Biosimilars Fact Sheet

Biosimilars may increase patient access to sight-saving drugs by reducing treatment costs and expanding options. Whether real-world outcomes following use of biosimilars are significantly different than those observed with reference molecules remains to be seen.

Biosimilars are biologics, meaning these large, complex molecules are derived from live organisms. Quality-control monitors ensure consistency throughout production.

Biosimilars are based on reference molecules, which is a biologic off of which a biosimilar is based. Biosimilars have similar bioactivity to their reference molecules, and no clinically meaningful differences have been observed between them.

Biosimilars must receive FDA approval prior to use in the United States, which requires a demonstration of biosimilarity in prespecified endpoints in pivotal studies.

Suprachoroidal Injection

CLS-AX/axitinib (Clearside Biomedical)
KPI-287 (Kala Pharmaceuticals)

Polymer-Based

OTX-TKI (Ocular Therapeutix)
GB-102 (Graybug Vision)
KSI-301 (Kodiak Sciences)
AR-13503 (Aerie Pharmaceuticals/Alcon)
EYP-1901 (EyePoint Pharmaceuticals)

2023 Retina Pipeline: A View Into Ongoing Innovation [Interactive]

Download the Pipeline PDFs

“On the...wet AMD [side], you'll notice an expanded list of anti-VEGF and anti-PIGF agents, including multiple biosimilars...The dry AMD [side]...has undergone significant expansion with the addition of several drugs that target the complement pathway in an effort to suppress inflammation.”

A. Suppress Inflammation

B. Stem Cells

C. Other approaches

D. Reduce Toxic By-product Accumulation

E. Neuroprotection

F. Visual cycle modulation

G. HtrA1 Inhibition

Tyrosine Kinase inhibitor (TKi) Pathways

TIE2 Activation Pathways

Integrin Pathways

PAN

Gene Therapy

Other Pathways

Extracellular VEGF Pathways

The Cutting Edge

Suprachoroidal Injection

Polymer-Based

Did we miss a drug candidate?

Peter K. Kaiser, MD

Marielle Mahan, MD