An open-label, multicenter, single dose escalation study evaluating the safety of a single intravitreal injection of three increasing doses of THR-687 found patients who received the highest dose experienced the best gains in vision and reduction of central subfield thickness.
Arshad M. Khanani, MD, presented the results of the phase 1 study at Bascom Palmer Eye Institute’s Angiogenesis, Exudation, and Degeneration 2020 symposium in Miami. Study participants received a single intravitreal injection of three increasing doses — 0.4 mg, 1 mg and 2.5 mg — of THR-687 (Oxurion) for the treatment of diabetic macular edema.
“The phase 1 safety study of THR-687, a pan-RGD integrin antagonist, in patients with previously treated DME showed that THR-687 was safe and well tolerated without any dose-limiting toxicities or serious adverse events,” Khanani told Healio/OSN.
Across all doses, participants experienced a gain of 3.1 letters by day 1, with an improvement to 9.2 letters at month 1. Best corrected visual acuity gains were maintained at 8.3 letters at month 3.
“Also, the patients treated with the single injection of high-dose THR-687 had significant visually acuity gains by 1 month post-injection and the gains continued till 3 months,” Khanani said.
Participants treated with the highest-dose injection experienced a mean BCVA improvement of 11.2 letters at day 14 and a peak mean improvement of 12.5 letters at month 3. A peak mean central subfield thickness decrease of 106 µm was observed at day 14, according to Khanani.
According to Patrik De Haes, MD, CEO of Oxurion, in a company press release, phase 2 of the study in treatment-naive patients with DME will begin in the second half of 2020. – by Robert Linnehan
Khanani A. A phase 1 study of THR-687: An integrin antagonist for the treatment of diabetic macular edema. Presented at: Angiogenesis, Exudation, and Degeneration 2020; Feb. 8, 2020; Miami.
Disclosure: Khanani reports he is a consultant for and receives research support from Oxurion.