June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
A Phase 1/2a Study of ALY688 Ophthalmic Solution in Dry Eye Subjects
Author Affiliations & Notes
  • Kenneth Sall
    Allysta Pharmaceuticals Inc, Bellevue, Washington, United States
  • Gary Foulks
    Allysta Pharmaceuticals Inc, Bellevue, Washington, United States
  • Stephen C Pflugfelder
    Baylor College of Medicine, Houston, Texas, United States
  • David Evans
    Total Eye Care, Memphis, Tennessee, United States
  • Philip Shettle
    Shettle Eye Research Inc., Largo, Florida, United States
  • Jeanette Stewart
    Allysta Pharmaceuticals Inc, Bellevue, Washington, United States
  • Henry Hsu
    Allysta Pharmaceuticals Inc, Bellevue, Washington, United States
  • Footnotes
    Commercial Relationships   Kenneth Sall None; Gary Foulks None; Stephen Pflugfelder None; David Evans None; Philip Shettle None; Jeanette Stewart None; Henry Hsu None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 3959. doi:
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    • Get Citation

      Kenneth Sall, Gary Foulks, Stephen C Pflugfelder, David Evans, Philip Shettle, Jeanette Stewart, Henry Hsu; A Phase 1/2a Study of ALY688 Ophthalmic Solution in Dry Eye Subjects. Invest. Ophthalmol. Vis. Sci. 2023;64(8):3959.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Ocular surface damage with chronic inflammation are key features of dry eye disease. ALY688 is a novel small peptide analogue of adiponectin with epithelial wound healing and broad anti-inflammatory actions. We conducted a Phase 1/2a study to evaluate the safety and exploratory efficacy of ALY688 in subjects with moderate-to-severe dry eye disease.

Methods : This was a first-in-human, randomized, double-masked study of ALY688 Ophthalmic Solution (0.1% and 0.4%) vs vehicle (Veh) (1:1:1) applied topically BID for 8 weeks. After a 2-week run-in, randomized subjects were seen at Weeks 2, 4, and 8. The primary objective was ocular safety; exploratory activity included change from baseline (BL) in: conjunctival lissamine green staining (CLGS), corneal fluorescein staining (CFS), eye dryness score (EDS), Schirmer’s tear test (STT), and tear breakup time (TBUT).

Results : All 138 randomized subjects completed treatment. ALY688 was well tolerated with a low rate of ocular adverse events (AEs): ALY688 0.1%: 22%; ALY688 0.4%: 15%; Veh: 26%. The most common AE was transient post-instillation discomfort (all mild). A dose response was seen in CLGS, CFS, and EDS, with ALY688 0.4% showing greater improvements compared with Veh with consistent results at Week 4 and 8. At Week 8, the improvement from BL in mean ± SD CLGS score was greater for ALY688 0.4% [-1.68 ± 3.38 units] vs Veh [-0.34 ± 2.29 units] (p = 0.043) in subjects with BL staining. Similarly, for CFS, a larger decrease was seen for ALY688 0.4% [-2.90 ± 2.34 units] vs Veh [-2.00 ± 2.25 units] (p = 0.079). Large improvements (≥4-unit decrease) in CFS were seen in 41% in ALY688 0.4% (n=39) vs 18% in vehicle (n=38) (p = 0.03). Individual zones for both measures favored ALY688 0.4% with separation from vehicle at 2 weeks. In post hoc analyses of EDS, subjects with BL EDS >40 showed greater improvement in the ALY688 0.4% group vs Veh (mean difference: -7.27 units; p = 0.067). For STT, ALY688 0.4% trended towards improvement vs Veh. TBUT showed no differences.

Conclusions : ALY688 Ophthalmic Solution was safe and well tolerated at both doses. ALY688 0.4% showed consistent improvements in ocular surface staining (both cornea and conjunctiva) and symptoms as early as 2 weeks. Based upon these encouraging results, a Phase 2b/3 study (N=900) evaluating 0.4% and 1% is underway with data expected in 2023.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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