Tarsier Pharma shares results from phase 3 TRS4VISION trial

TRS01 demonstrates clear anti-inflammatory activity in noninfectious anterior uveitis with no evidence of significant adverse effects. (Image Credit: ©9nong - Adobe.Stock.com)

Tarsier Pharma has shared results from the phase 3 TRS4VISION trial evaluating TRS01 (eye drop formulation of dazdotuftide) in noninfectious uveitis and specifically in uveitic glaucoma.

The company released these results in a press release and stated “TRS01 demonstrates clear anti-inflammatory activity in noninfectious anterior uveitis with no evidence of significant adverse effects”¹

While the primary endpoints were not met, the company stated a post hoc analysis of the data “demonstrates the much-anticipated clinical profile of a blend of safety and actively resolving inflammation that is promising in the treatment of noninfectious uveitis and specifically in uveitic glaucoma.”¹

The primary endpoint was the proportion of patients reaching total resolution of inflammation (zero cells) in week 4.

TRS4Vision was a randomized, multi-center, active-controlled, double-masked study to evaluate the safety and efficacy of TRS01 eye drops in the treatment of subjects with active noninfectious anterior uveitis including subjects with uveitic glaucoma. It enrolled 142 patients with 30 clinnical sites across the US and Europe.¹

Patients were randomized 2:1 to receive TRS01 - 1% ophthalmic solution or a steroid active-control eye drop for 4 weeks, followed by a 2-week follow up period.

Secondary endpoints including ocular pain and flare were found to be comparable between TRS01 and the steroid active control arm.

Regarding sustained resolution of inflammation, steroid active control was effective at the end of the treatment period. However, inflammation resolution was transient, with a 2-fold higher rate of rebound (relapse of inflammation within 2 weeks) compared to the TRS01 treatment arm and up to 6-fold higher rate of rebound compared to TRS01 treatment arm in a pre-specified subgroup.¹

Intraocular pressure showed 2.6-fold higher rate in the steroid active control arm, showing a meaningful IOP elevation after 4 weeks of treatment compared to the TRS01 arm.¹

According to the company, the TRS4Vision data “demonstrated the potential of TRS01 ophthalmic solution to deliver a risk-benefit product profile of sustained resolution of inflammation and stable IOP.”

Ron Neumann, MD, Tarsier Pharma CMO, revealed 3 pivotal lessons set to “reshape the landscape of uveitic glaucoma management,” in the press release.¹ Neumann’s lessons are:

1. Based on the response level to TRS01 and favorable safety profile, the drug is active in resolving inflammation
2. Noteworthy IOP levels, suggests TRS01 emerging as a front-runner for the safest treatment option in uveitic glaucoma.
3. TRS01 anti-inflammatory activity, coupled with its non-elevated risk of glaucoma, and sustained efficacy post-discontinuation, promises to revolutionize treatment paradigms.

Daphne Haim-Langford, PhD, president and CEO of Tarsier stated, “we are excited about these results. We are grateful to the many patients, caregivers, and physicians who have enabled the development of TRS01 and are encouraged by the opportunity TRS01 may have in meaningfully improving quality of lives of patients in need. Based on the TRS4Vision trial results, we plan to engage with regulators to determine the optimal path forward to bring TRS01 to patients as expeditiously as possible."

According to the company, plans are underway to meet with regulatory agencies to determine the optimal path forward for TRS01.

Topline data from the TRS4Vision trial will be presented in an oral presentation at the IOIS 2023 Congress.

References:

1. Tarsier Pharma Announces Results from a Phase 3 Clinical trial in Subjects with Noninfectious Anterior Uveitis Including Subjects with Uveitic Glaucoma. Tarsier. Press Release. August 23, 2023. Accessed August 24, 2023. https://www.prnewswire.com/news-releases/tarsier-pharma-announces-results-from-a-phase-3-clinical-trial-in-subjects-with-noninfectious-anterior-uveitis-including-subjects-with-uveitic-glaucoma-301907809.html