Despite the pandemic upending our lives in countless ways, U.S. clinical trial enrollment accelerated through 2021, with many trials closing earlier than anticipated. Never before has a year dawned holding so many anticipated, important new data releases in our space, each with the potential to meaningfully impact how we manage patients. 

In neovascular age-related macular degeneration, we’ll see primary outcome data from DAZZLE, the Phase III noninferiority trial in which aflibercept is being compared to the anti-VEGF antibody biopolymer conjugate KSI-301 (Kodiak Sciences) given every 12, 16 or 20 weeks (there’s no eight-week arm) after three loading doses. Second, the ARCHWAY Phase III trial of the recently approved Susvimo port-delivery system (Genentech/Roche) will yield two-year data.

In geographic atrophy, we’ll see two-year data from the pegcetacoplan (Apellis) Phase III DERBY and OAKS trials, and one-year data from the Phase III GATHER2 trial of Zimura (avacincaptad, IVERIC bio).

In addition, two therapeutics with multiple programs are expected to bear fruit. We will see data from the high-dose aflibercept 8 mg (Regeneron Pharmaceuticals) Phase III programs in both nAMD (PULSAR) and diabetic macular edema (PHOTON). 

Finally, it will be a busy year for the recently approved Vabysmo (faricimab-svoa, Genentech/Roche). In addition to two-year data from the nAMD and DME Phase III programs (TENAYA and LUCERNE; YOSEMITE and RHINE), we may see data from the Phase III BALATON and CAMINO trials in retinal vein occlusion as well.

Beyond this alphabet soup of pivotal trials, there are a plethora of Phase I and II trials expected to produce new data, including multiple trials of gene therapy delivered by intravitreal, suprachoroidal or subretinal approaches, optogenetics programs, numerous tyrosine kinase inhibitor programs, and multiple drugs with completely novel mechanisms of action and unique delivery routes, such as oral, sub-cutaneous and drop formulations.

Consider communicating to your patients the breadth of ongoing, promising retina research. For patients with untreatable pathologies such as GA, hearing cautiously optimistic perspectives that new therapeutics that could slow their disease are in late-stage trials may give them a refreshing ray of hope. For patients receiving repeated injections, awareness of programs evaluating therapeutics with meaningfully increased durability may motivate them to hang in there until next-generation pharmacotherapies are available. 

This year will witness several meaningful clinical trial readouts. I look forward to continuing to move our space forward with you, together. RS