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According to the phase II/III DIAMOND trial, there was early evidence of efficacy for OCS-01 eye drops in patients with diabetic macular edema (DME) compared with sham. The findings were reported at the American Academy of Ophthalmology annual meeting.

In this exclusive 番茄社区 video, Hani Salehi-Had, MD, of Retina Associates of Southern California in Huntington Beach, describes the results and future potential of this treatment.

Following is a transcript of his remarks:

In this particular clinical trial, we looked at the dosing regimen that would be appropriate to take this phase I of the trial into the next stage. And we wanted to see if treatment of diabetic macular edema that's clinically significant with OCS-01 eye drops six times a day and following that up with treatment three times a day after doing that for the first 6 weeks would, first of all, have a vision benefit compared to no treatment or sham, and whether that treatment benefit at 6 weeks would be sustained through 12 weeks. That was the primary endpoint ... visual acuity improvement at 6 weeks.

The secondary endpoints that we looked at were central macular thickness at week 6 and 12, as well as visual acuity improvement at week 12. And, of course, just like with any other trial, we looked at the AEs [adverse events] carefully with this particular treatment.

So, in terms of results, the improvement in visual acuity was clinically significant with seven [Early Treatment Diabetic Retinopathy Study] letters gained at week 6, and this was sustained through week 12. Central macular thickness actually decreased significantly at week 2, and that decrease was maintained through week 12. And again, week 12 results were consistent, meaning that the improvement that was seen after the first initial loading dose phase was maintained with three times a day of eye drops.

In terms of adverse events, there were no unexpected AEs, or adverse events, and certainly no SAEs, or serious adverse events, that were thought to be due to the eye drops.

In terms of increase in intraocular pressure, there was a small rise in intraocular pressure, with a medium rise of just above two, and very few people had -- about 14% of people -- had an increase of intraocular pressure of 10 at any time point, and only one person had an intraocular pressure of 35.

It's nice to have an eye drop that's a noninvasive way of treating patients with diabetic macular edema, and even if it's not for every patient, there will certainly be a subset of patients that will benefit from these treatments. And it may very well be the first line of therapy for diabetic macular edema at the end of the next stage of the trial -- we'll see what the results show us.

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