07.26.18

EyePoint Pharmaceuticals Announces Presentation of Data Highlighting Yutiq for Posterior Segment Uveitis

Source: EyePoint Pharmaceuticals

EyePoint Pharmaceuticals announced the presentation of 12-month efficacy and safety data supporting the company’s Yutiq (fluocinolone acetonide intravitreal implant) 0.18 mg 3-year micro-insert for noninfectious posterior segment uveitis. The data were presented at the American Society of Retina Specialists (ASRS) in Vancouver.

“Data from the phase 3 program continue to support the potential for Yutiq to serve as an effective and safe therapy in the thousands of patients suffering from noninfectious posterior segment uveitis,” Nancy Lurker, President and Chief Executive Officer, said in a company news release. “Our NDA for Yutiq for posterior segment uveitis is currently under review by the FDA, with a PDUFA action date of November 5, 2018. Noninfectious posterior segment uveitis represents the third leading cause of blindness in the U.S., and, if approved, we believe that Yutiq could serve as a much needed treatment option for this area of high unmet need.”

Summaries of the ASRS presentations are as follows:

Title: Confirmatory 1-Year Study Results of an Injectable Fluocinolone Acetonide Intravitreal Insert to Treat Noninfectious Posterior Segment Uveitis 
Presenter: Glenn J. Jaffe, MD, Robert Machemer Professor of Ophthalmology, Duke Eye Center
Session Title: Inflammatory and Infectious Diseases Symposium

In this 3-year prospective, multicenter, randomized, double masked phase 3 study, 153 subjects with noninfectious posterior segment uveitis (NIPU) with a history (>1 year) of recurrent NIPU were randomized to receive either an injectable fluocinolone acetonide intravitreal insert (FAi) (N=101) or sham injection (N=52). Efficacy and safety of the FAi were evaluated at one year, with a primary endpoint of NIPU recurrence.

 

Uveitic recurrences affecting the posterior segment or requiring rescue with peri- or intraocular steroids and/or systemic treatment were reported for 32.7% of FAi treated eyes versus 59.6% of sham eyes (P=0.002). Both groups had small improvements in mean visual acuity at one year, and macular edema was resolved in 67.7% versus 57.1% of FAi and sham eyes, respectively, that had edema recorded at baseline. Through one year, 23.8% and 7.7% of FAi and sham subjects, respectively, experienced IOP increases ≥12 mm Hg in the study eye, with one of the FAi study eyes requiring IOP lowering surgery. Cataract surgery was performed on 18.0% and 8.6% of phakic study eyes in the FAi and sham groups, respectively. The results of this study support previous findings that the FAi is effective to both treat and prevent recurrent uveitis, with transient and/or manageable side effects.

Title: Controlling Uveitic Recurrences: Results From a Phase 3 Study of 0.18 mg Fluocinolone Acetonide Insert (FAi) in Noninfectious Posterior Uveitis
Presenter: Quan Nguyen, MD, MSc, Professor of Ophthalmology Byers Eye Institute, Stanford University
Session Title: Inflammatory and Infectious Diseases Symposium

In this prospective, randomized, double-masked phase 3 study, 129 subjects with a history (>1 year) of recurrent NIPU were randomized to receive either injectable FAi (N=87) or sham (N=42). The role of FAi in decreasing the rate of inflammation recurrence, as well as number of recurrent episodes, was evaluated.

 

During the first year of the three-year study, the recurrence rate in FAi randomized eyes was significantly lower than in sham eyes (37.9% vs. 97.6%, respectively; p<0.001). A total of 63 recurrences were reported in FAi treated eyes (0.7±1.22/eye) versus 105 recurrences in sham treated eyes (2.5±1.67/eye). Multiple (>1) recurrences were observed in 18.4% of the FAi treated eyes versus 67% of the sham treated eyes.


Title
: Injectable Fluocinolone Acetonide Intravitreal Insert Reduces the Need for Adjunctive Treatment in Noninfectious Posterior Segment Uveitis
Presenter: Sunil Srivastava, MD, Staff Physician, Cole Eye Institute, Cleveland Clinic
Session Title: Inflammatory and Infectious Diseases Symposium

In this controlled, prospective, double masked multicenter phase 3 study, 129 subjects who had experienced at least 2 separate recurrences of NIPU requiring ≥ 3 months of systemic therapy or ≥ 2 intra- or peri-ocular steroid injections and with a > 1-year history of the disease were randomized to treatment in one study eye with FAi (N=87) or sham (N=42) injection.

 

Analysis of the full intent-to-treat cohort (N=129) at one year indicated that a single intravitreal injection of FAi provided effective anti-inflammatory treatment for one year and significantly reduced the need for adjunctive therapies. 6.9% (6/87) of FAi eyes, versus 61.9% (26/42) of sham eyes received at least one intra/peri-ocular steroid injection. Of the 6 eyes that required intra/peri-ocular steroid injection, Four required only a single injection through 12 months while half of the 26 sham eyes required multiple injections up to maximum of five. Systemic treatment was used in 19.5% and 40.5% of FAi and sham patients, respectively. Topical Ophthalmic steroids were prescribed to 20.7% and 47.6% of FAi and sham eyes, respectively.

 

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