Access Barriers, Not Science, Slow Retina Care: Paul Hahn, MD

The biggest obstacle to translating retina’s technology pipeline into patient care is not the science but systemic barriers to access, including reimbursement gaps, operating room availability, and out-of-pocket costs, said Paul Hahn, MD, PhD, FASRS, founder of phRETINA Ophthalmology Care.

In part 1 of his interview with The American Journal of Managed Care® (AJMC®), Hahn discussed why ranibizumab (Susvimo; Genentech) has struggled to gain traction years after its approval and detailed the operational hurdles facing gene therapy and other emerging retina technologies. Here, he explains why trial results and real-world performance so often diverge, a pattern other retina specialists are reporting as well,¹ and reflects on how running his own independent practice, launched in 2025, has changed his view of technology adoption.

Looking ahead, he predicts gene therapy has the greatest potential to reshape neovascular age-related macular degeneration (wet AMD) care within 3 to 5 years, while tyrosine kinase inhibitors could offer a middle-ground option and stem cell therapies remain further out.

This interview was edited for clarity.

AJMC: We’ve started talking about trial results versus real-world outcomes. When a therapy or device shows strong trial results but underperforms in the real world, or is adopted more slowly than expected, are there any usual suspects for the reasons why? Is it patient selection, the control conditions of a trial, reimbursement, or something else entirely?

Hahn: I think there’s probably no single answer. Looking back over our experience over the past handful of years, there have been several different reasons why some products haven’t performed so well in the real world. One is safety: if safety events are identified in the real-world setting that weren’t identified during the clinical trials, that will, of course, dampen enthusiasm to use that drug.

There have also been drugs where I think the phase 3 clinical trial data were overpromised. The data are what they are, but the interpretation can be presented in different ways, and there are certain products where the results were, in effect, overdelivered and underperformed. Under those circumstances, retina specialists become a little disillusioned with the product. Then, of course, there are access issues. We talked earlier about Susvimo, and I think it has great potential, but surgical access issues are an important limit on its utilization, among other limitations.

From a safety standpoint, we as a society—in particular through the American Society of Retina Specialists—have developed an important safety-vigilance mechanism, so we’re very on top of new safety issues and can effectively monitor for them. I think industry has learned from the mistakes of prior products and learned how to launch a new product without overselling it. I think the biggest barrier, and the one we haven’t been able to address, is access-to-care issues; those are health care systems–related issues, which seem to be only getting worse.

AJMC: Since starting your own independent practice in 2025, how has your perspective on how new technologies and therapies get adopted changed, compared with when you were at a larger organization?

Hahn: Since starting my own practice, as opposed to a large university or private-practice setting, I’m much more involved in the practice-management side of things, and with that I’ve become more aware of the barriers to care. On one hand, being in this independent practice setting, I’ve come to very intimately recognize all the hurdles, challenges, and barriers to incorporating new technologies. On the other hand, now that I have my own practice, I can make the final decision as to whether I incorporate those or not.

Ultimately, what I love about having an independent practice is that I can make those decisions based on what I feel is best for patient care, as opposed to the myriad other factors that come into play in a corporate practice-of-medicine setting or an academic medicine setting. That’s really been one of the joys of having an independent practice.

AJMC: Doing a little forward-looking now, what change in the space do you think is most likely to upend how AMD is managed in the next 3 to 5 years? And what do you think might not take off that people are hoping would?

Hahn: I think without question gene therapy has the biggest potential to really upend things. From a practice-operations standpoint, having a potential one-and-done treatment really changes what our day-to-day looks like in the office. Currently, a lot of our day is spent performing intravitreal injections, and that can drastically change if gene therapy truly does emerge as a safe and effective option.

From a patient standpoint, that will really change things too. Being the closest thing to a cure for macular degeneration, diabetic macular edema, and other retinal vascular diseases, gene therapy has the prospect of revolutionizing the patient experience, from having to undergo very frequent, regular injections to something much different.

In terms of what hasn’t taken off: patients always ask about things like stem cells. I think stem cells are very attractive from a conceptual standpoint, our ability to regrow damaged tissue, but even though there’s exciting early research, that level of development hasn’t progressed to the phase patients often think it should be at. In the next three to five years, I’m not hopeful for stem cells, but over a longer horizon, I do think that’ll be an important way for us to restore something that’s otherwise been permanently lost.

AJMC: The idea of the one-and-done gene therapy is exciting, but when we think about how insurance is set up in the United States, there’s always the question of whether these and other new, expensive technologies and therapies will actually get covered.

Hahn: That’s the question: how are they going to get paid for? And are they going to be adopted widely? Something like home OCT [optical coherence tomography], for example, is different. The potential for adoption is widespread, and the cost may be high, but it’s not the same as a gene therapy, which is probably going to be a high-cost, one-and-done treatment. At every level, I think the health care system, both on the payer side and particularly on the provider side, is just being squeezed more and more. Everything’s a challenge.

AJMC: Is there a technology or mechanism that you think is being underappreciated by the field right now, one that’s not getting the attention it deserves?

Hahn: I’m not sure about underappreciated by the field, but one thing we haven’t discussed are tyrosine kinase inhibitors [TKIs]. That’s another exciting technology we’ll get much more information on over the next year or so; they’re rounding out their phase 3 trials, and we’ll have important safety and efficacy data very shortly.

What’s exciting about TKIs is that they provide a more durable option; we may see a 6-month injection option compared with our current armamentarium. That may not be as good as the potential one-and-done of gene therapy, but for many retina specialists, this might be a good bridge or sweet spot, bringing patients in at a regular cadence where we can still follow them, without letting them go entirely as we transition to longer-acting therapies. Some TKIs also have the potential to target novel mechanisms of action. It’s an exciting option we should be on the lookout for over the next 6 to 12 months as we get more information.

AJMC: Finally, if you could change one thing about how new retina technologies move from clinical trial to real-world, widespread adoption, what would that be?

Hahn: It’s so exciting that we have so many new technologies that are either here or coming; a lot of what we can do now is like science fiction if we think back even 10 years ago. What’s most unfortunate is that our barriers to providing the best patient care aren’t necessarily driven by our ability to develop these technologies, but by more systemic barriers to access to care.

When we think about patient care and our health care system, cost is very important, and we need to factor that in. I’m a little concerned that our health care system doesn’t always optimize what’s best for the patient. I’m not sure what the solution is; it’s a very difficult problem, but at least from where I sit as a physician, we always have to think about the patient first.

References

1. Joszt L, Regillo C. Real-world wet AMD outcomes still lag trial results: Carl Regillo, MD. AJMC. July 1, 2026. Accessed July 10, 2026. https://www.ajmc.com/view/real-world-wet-amd-outcomes-still-lag-trial-results-carl-regillo-md