New Retina Radio

08.18.26

The Story Behind LYTENAVA™: From FDA Approval to Retina Practice

In this episode of New Retina Radio, host Barry Kuppermann, MD, PhD, sits down with Bob Jahr, CEO of Outlook Therapeutics, to discuss the FDA approval of LYTENAVA™ (bevacizumab-vikg), the only FDA-approved ophthalmic bevacizumab formulation for nAMD.^1,2 They explore the regulatory journey over the course of more than 8 years,³ the rigorous FDA review process,⁴ manufacturing and product quality, commercialization plans, payer considerations, and future development. Please see the Important Safety Information and full US Prescribing Information for LYTENAVA.

Intended for a US audience only.
Sponsored by Outlook Therapeutics

References
1. Harp MD. FDA approves Outlook Therapeutics' LYTENAVA for the treatment of wet AMD. Ophthalmology Times. Published July 24, 2026. Accessed July 28, 2026. https://www.ophthalmologytimes.com/view/fda-approves-outlook-therapeutics-lytenava-for-the-treatment-of-wet-amd
2. LYTENAVA™ (bevacizumab-vikg) prescribing information. Outlook Therapeutics; 2026.
3. Outlook Therapeutics. Oncobiologics changes name to Outlook Therapeutics; announces next steps in executing ONS-5010 clinical and regulatory strategy. Published December 3, 2018. Accessed July 24, 2026. https://ir.outlooktherapeutics.com/news-releases/news-release-details/oncobiologics-changes-name-outlook-therapeutics-announces-next
4. US Food and Drug Administration. The FDA's drug review process: ensuring drugs are safe and effective. Updated January 4, 2018. Accessed July 28, 2026. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective

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Announcer (00:00):

This episode of New Retina Radio is sponsored by Outlook Therapeutics.

Please stay to the end of the episode to hear Indication and Important Safety Information.

Barry Kuppermann, MD (00:13):

Welcome to this episode of New Retina Radio. I'm Barry Kuppermann, the chair of the Department of Ophthalmology at the University of California Irvine, and a practicing retina specialist. Today we're talking to Bob Jahr, president, and CEO of Outlook Therapeutics. Bob, thanks for joining us.

Bob Jahr (00:28):

Thanks for having me, Dr. Kuppermann.

Barry Kuppermann, MD (00:30):

Please call me Barry. Recently, the FDA approved the first ophthalmic formulation of bevacizumab developed for wet AMD._1,2 Congratulations on the approval of LYTENAVA. Let's discuss what this milestone means for retina specialists, and our patients.

Bob Jahr (00:45):

It has been quite a journey and, uh, we have a phenomenal team that's been very resilient during that. It's been over eight years since we first partook on this journey with the FDA.³ And during that time, I think many people are aware that we had three, um, what we call CRLs, or complete response letters.¹ And what those are, they're just, uh, dialogue with the FDA where they're not ready for, um, approval, but they're seeking more information, or more clarification, or more data.⁴

And so our first one of those was back in 2023, and many CRLs related to CMC, and there was a CMC, or manufacturing related topics there, but also at that time they asked for additional trial. And then the last 12 months, we actually had two CRLs. And, uh, and they were related to the interpretation of that trial from the first one. So, the great news is none of them raised any issues with safety, or manufacturing, which is fantastic, but it, it did require us to further engage with the FDA.¹

And then on the third one, we, we found ourselves just in, at an impasse, and we initiated on the appeal process. And where we are today is because that appeal process determined, and gave direction to the FDA to, that we had satisfied all the requirements, both for safety, and efficacy, and a lot of that's why we're here today.¹

Barry Kuppermann, MD (01:56):

Sounds much more complicated than the normal process, but with these three CRLs now in approval, is there a reason the retina community should feel concerned, or should we feel confident about LYTENAVA?

Bob Jahr (02:06):

Yeah, I think if anything, they should feel incredibly confident. And here's, I'm going to tell you why. In the last two, we have not had any safety discussions with the FDA. There's been no requirement for additional safety information. Uh, a lot of it had to do with how we're interpreting efficacy endpoints.¹

So, safety manufacturing, which is very critical as we talked about in the bevacizumab space in retina, is fundamental.⁵ And so I would say as a, if we come to this, we've passed a threshold in a, in a bar that nobody else has had to do in terms of getting to the market for wet AMD in ophthalmology for bevacizumab.^1,2

Barry Kuppermann, MD (02:39):

So, what can you tell me about the product consistency, potency, those sorts of issues?

Bob Jahr (02:44):

So, with the FDA process, everything from the very beginning, um, you know, not just all of our data, and our clinical studies, and the endpoints for those studies, and the safety, but also all the way into the manufacturing. And it's everywhere from the drug product, or the drug substance, the drug product, you know, what ultimately gets into the vial. All of that is open for, um, review, and inspection, and audit, and reporting to the FDA. So, I think they should feel very, very confident in that process, that alone. Then having to look at all of our safety, and efficacy data, and review that, um, to, to come back with the label that we have today.⁶ So, I, I would, again, say it's, uh, it's, they should feel incredibly confident that they have something that they have not had in over 20 years in terms of treating bevacizumab for wet AMD.^2,7

Barry Kuppermann, MD (03:31):

Well, we certainly have been using compounded bevacizumab over these past 20 years, or so.^2,7 I know one of the concerns that we've had all along has been, for example, excipients that are not designed to be for the eye.⁷ Can you talk about, about the formulation, and those distinctions?

Bob Jahr (03:47):

Yeah. So, this formulation, and it's - in its dosing, and its potency was specific for ophthalmology use, right? So, unlike what has been used before where it was used for, um, oncologic indications, and there had to be some repletion in terms of that dose, this one was specifically, uh, developed, studied, and manufactured for injection into the eye for wet AMD.^2,7

Barry Kuppermann, MD (04:10):

Again, having used bevacizumab, uh, compounded formulation for many years, for all that we've used it, there's always been concerns about publications we've seen that are, show variability of the potency from vial to vial, syringe to syringe. And then of course, we've all seen the issues surrounding compounding pharmacies, and some of the delivery methods.⁵ So, any thoughts about the, the one of the, that's another distinguishing feature, I think, that's quite significant between where you are now, and where we have been. Could you talk about that a little bit more?

Bob Jahr (04:40):

Yeah, I mean, I think it's very exciting that, you know, for the first time into your practices, into your patients, you, you have the background of over eight years of studying, and review of quality manufacturing, FDA reviewed manufacturing, um, and then also the data, and efficacy, and safety data that comes along with it. ^3,6 As well as we now, uh, at Outlook, we bear the responsibility. If you have an, if you have any challenges, you know, do we, we report that to the FDA? Do we, you know, that hasn't been there before. So, the accountability resides on us every day, every patient, every day. And as we've seen in our experience in Europe, we're incredibly confident that physicians are going to be very happy, and pleased, and so will the patients with what we're bringing to the market.

Barry Kuppermann, MD (05:22):

Well, can you clarify that? So, it's already been approved in Europe.

Bob Jahr (05:25): Yes.

Barry Kuppermann, MD (05:25):

So, because we're used to, for example, the complement inhibitors being approved in the United States, but not in Europe, but you've already gotten approval in Europe.⁸

Bob Jahr (05:32):

Yes. We've been in, approved in Europe for a- almost over two years, and a nice recommendation as well. And we've been commercializing there. So, um, obviously the EMA had, you know, has different requirements that they wanted for the approval there.⁸ So, they're a little bit ahead of us, which has been great. It's been giving us an opportunity to, to learn how the market responds to that.

Barry Kuppermann, MD (05:50):

Again, one of the concerns that I know the retina community may have, uh, is what impact this approval of LYTENAVA as a, now a pharmacy grade, or a ophthalmic grade, uh, product for the eye for bevacizumab have on the availability of compounded bevacizumab. Any thoughts about that?

Bob Jahr (06:06):

Yeah, I mean, as, as we get prepared to commercialize, uh, it should not have any impact. I mean, not from our perspective. There are regulations out there, of course, that, that aren't beyond my control. But I mean, I think right now, we're excited to bring an FDA approved option, and opportunity, and product for physicians to choose, and another, uh, another, um, I guess, uh, potential treatment for patients. And, and we want the physicians to treat that, right? We're, we're, we're not here to take options away from patients, and practices. We're here to bring one with everything that we've done to study its efficacy, and safety in manufacturing.

Barry Kuppermann, MD (06:38):

That's good to hear. And what about possibilities on payer reaction? Again, we're living in a world of step therapy. How do you envisage this working its way into the system?

Bob Jahr (06:47):

It's a great question. Uh, you know, we're just recently, just within days of the approval, so we have a lot of work to do here over the next several weeks, and we have been engaging with payers previously, and we'll begin to again. The market has evolved, and so we don't anticipate, um, significant payer changes because they have had this step edit for bevacizumab for some time. But it, it's, it's up to us to, to get in there, engage with the payers, and then bring that information back to the community.

Barry Kuppermann, MD (07:11):

Another thing that we like having are prefilled syringes. Uh, is this coming in a vial, and a prefilled syringe? And if it's in a vial, what is the plan for getting to a prefilled syringe at some point?

Bob Jahr (07:20):

So, first, most importantly, we, we're approved today in a vial format, as we are in Europe.^2,9 Um, are excited, and we haven't provided details on the PFS program in terms of timing. We had to get this approval so that we can move forward with the PFS, and we want to move forward with that as soon as possible, and quickly as possible, but that was all contingent upon the testing required for the prefilled syringe after we got approval, um, recently.

Barry Kuppermann, MD (07:43):

It's always been a bit remarkable with us as practicing retina specialists how much more difficult it is to have a prefilled syringe. And so we've gotten used to products arriving first in a, typically not all the time, but most of the time in a vial, and then eventually getting that. So, that's still the plan from your standpoint.

Bob Jahr (07:56): Absolutely.

Barry Kuppermann, MD (07:57):

All right. Well, thanks again, Bob, for sharing the story of Outlook Therapeutics efforts to bring FDA approved ophthalmic bevacizumab to the retina market, and our patients. Any closing thoughts?

Bob Jahr (08:07):

Well, thanks again for the opportunity to be here today. And, uh, you know, a, a few closing thoughts are we're incredibly excited, um, to, to come to, to the market. And more importantly, I want to thank all the retina community, um, for their support. Um, they really helped sustain the resilience of this team. I have an amazing team at Outlook Therapeutics that were diligent in sticking t-through this with the FDA while we were commercializing in Europe, and waiting for this moment. And I really want to thank the support of this community, uh, for that.

Barry Kuppermann, MD (08:34):

Bob, we appreciate the open conversation on LYTENAVA. This marks the beginning of a new chapter, and I'm excited to see what's next for Outlook Therapeutics. Thanks everyone for joining us on New Retina Radio.

Bob Jahr (08:45): Thank you, Barry. It's been great talking to you today.

Announcer (09:10):

Important Safety Information and Indication

LYTENAVA (bevacizumab-vikg) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD).

Contraindications

LYTENAVA is contraindicated in patients with ocular or periocular infections, in patients with active intraocular inflammation, and in patients with a known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation.

Warnings and Precautions

Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.

Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately.

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Adverse Reactions

The most common adverse reaction (>=1%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%), eye pain (2%), and vitreous floaters (2%). These are not all the possible side effects of LYTENAVA.

You are encouraged to report side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Outlook Therapeutics at 1-833-999-OTLK (6855).

Please see the full US Prescribing Information for LYTENAVA at www.LYTENAVA.com/PI.

References

1. Harp MD. FDA approves Outlook Therapeutics' LYTENAVA for the treatment of wet AMD. Ophthalmology Times. Published July 24, 2026. Accessed July 28, 2026. https://www.ophthalmologytimes.com/view/fda-approves-outlook-therapeutics-lytenava-for-thetreatment-of-wet-amd

2. LYTENAVA(TM) (bevacizumab-vikg) prescribing information. Outlook Therapeutics; 2026.

3. Outlook Therapeutics. Oncobiologics changes name to Outlook Therapeutics; announces next steps in executing ONS-5010 clinical and regulatory strategy. Published December 3, 2018. Accessed July 24, 2026. https://ir.outlooktherapeutics.com/news-releases/news-release-details/oncobiologics-changesname-outlook-therapeutics-announces-next

4. US Food and Drug Administration. Complete response letters. openFDA. Accessed July 29, 2026. https://open.fda.gov/apis/transparency/completeresponseletters/

5. Yannuzzi NA, Klufas MA, Quach L, et al. Evaluation of compounded bevacizumab prepared for intravitreal injection. JAMA Ophthalmol. 2015;133(1):32-39.

6. US Food and Drug Administration. The FDA's drug review process: ensuring drugs are safe and effective. Updated January 4, 2018. Accessed July 28, 2026. https://www.fda.gov/drugs/informationconsumers-and-patients-drugs/fdas-drug-review-process-ensuring-drugs-are-safe-and-effective

7. AVASTIN® (bevacizumab) prescribing information. Genentech, Inc. 2025.

8. European Medicines Agency. Lytenava: EPAR - medicine overview. Marketing authorisation issued May 27, 2024. Updated June 29, 2026. Accessed July 15, 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/lytenava

9. Outlook Therapeutics NL B.V. Lytenava 25 mg/mL solution for injection: Summary of Product Characteristics. Updated April 30, 2026. Accessed July 29, 2026. https://www.medicines.org.uk/emc/product/100349/smpc