Retina Society 2024: First time phase 2 clinical trial results for ONL-1204 for rhegmatogenous retinal detachment

Durga Borkar, MD, sat down with Sydney Crago of Modern Retina to discuss one of her presentations on the first time phase 2 clinical trial results for ONL-1204 for rhegmatogenous retinal detachment from the Retina Society meeting being held this year in Lisbon, Portugal.

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity.

Sydney Crago:

Hi. I'm Sydney Crago with Modern Retina, and I'm here today with Dr Durga Borkar to talk a little bit about her presentations at the upcoming Retina Society meeting. Your second presentation, which will focus on the phase 2 clinical trial results of ONL-1204, can you provide a summary of, kind of, what these results are?

Durga Borkar, MD:

Sure, so this was a phase 2 study that was kind of set up as a real-world study, and enrolled about 6 months ahead of anticipated, which is great. ONL-1204 is a novel, first-in-class agent that is designed to inhibit the FAS receptor, which is a member of the TNF family of receptors, and is really a critical regulator of cell death and inflammation. And we know, you know, patients with rhegmatogenous retinal detachment, even with timely surgical repair, can lose quite a bit of vision. So any type of adjuvant treatment that may help improve outcomes is really imperative for these patients. So in this phase 2 clinical trial, patients with rhegmatogenous retinal detachment were randomized to 2 doses of ONL-1204, either 50 micrograms or 200 micrograms. They received a single intravitreal injection of ONL-1204 ophthalmic solution or sham as an adjunct to standard of care surgical repair for their retinal detachment. So the treatment was administered at the baseline visit, and then surgical repair was scheduled between 12 hours after the intravitreal injection up to 10 days, and then patients were followed for 6 months. And so in this study, what we saw was that the primary endpoint of contrast sensitivity was similar across groups. However, given the unique mechanism of action of FAS inhibition, ONL-1204 ophthalmic solution delivered intravitreally did demonstrate visual benefit for those most at risk of vision loss. So these were patients with rhegmatogenous retinal detachment of greater than 8 days of macula off status. And this was really seen best in pseudofacic patients, where post-vitrectomy cataracts were not an issue.

Sydney Crago:

Keeping this data in mind, what would you say are the key takeaways from this, this dataset?

Durga Borkar, MD:

Yeah, I think this was a really, you know, exciting trial. We do really need something to help improve our visual outcomes for patients with rhegmatogenous retinal detachment, and these results are promising. I think the results of this study really help inform the design of subsequent clinical trials evaluating this and really show promise as an adjutant for RRD repair.

Sydney Crago:

What's the next step for this research with ONL-1204?

Durga Borkar, MD:

So, the next steps for this research are to continue to do subgroup analyzes of these phase 2 data and publish these results, along with plans to meet with the FDA for an end of phase 2 meeting.