Clearside Biomedical (NASDAQ:CLSD) has outlined development plans for its Zuprata proprietary form of the corticosteroid triamcinolone, acetonide, for the treatment of macular edema associated with non-infectious uveitis, macular edema associated with retinal vein occlusion (RVO) and diabetic macular edema (DME).
In the third quarter report, CEO, Daniel White, said Clearside is continuing to enroll patients in PEACHTREE, its Phase 3 trial of suprachoroidal Zuprata in macular edema associated with non-infectious uveitis.
The six-month pivotal trial is expected to enroll approximately 150 patients, with approximately 90 patients randomized into an active treatment arm to receive suprachoroidal Zuprata and approximately 60 patients randomized into a control arm to receive a sham suprachoroidal procedure with no drug administered.
Clearside also intends to initiate Phase 3 trials of suprachoroidal Zuprata in treating RVO in the first half of 2017.
While Clearside plans to announce detailed information about the Phase 3 RVO program at a later date, Mr. White said the trials are being designed to assess whether suprachoroidal Zuprata in combination with intravitreal aflibercept show superior visual acuity outcomes, compared with monthly injections of intravitreal aflibercept alone.
“We believe that an injection of Zuprata administered to the suprachoroidal space, along with an intravitreal injection of an anti-VEGF agent like aflibercept, has the potential to improve visual outcomes relatively rapidly, as compared to treatment with anti-VEGF monotherapy,” Mr. White added.
In addition, he said Clearside is planning a multi-center, open-label Phase 1/2 trial to evaluate a combination therapy of aflibercept and Zuprata, as well as Zuprata monotherapy, in patients with DME over a six-month evaluation period.
The company expects to enroll the first patient in this trial before the end of 2016.
Regarding wet AMD, Mr. White said Clearside is developing a proprietary suspension formulation of axitinib and has scheduled a pre-IND meeting with the FDA prior to the end of 2016. Following this meeting, the company expects to submit an IND application for axitinib.