Palatin Technologies Eyes Growing $6B Dry Eye Disease Market With Late-Stage Study Data
Palatin Technologies Eyes Growing $6B Dry Eye Disease Market With Late-Stage Study Data
On Monday, Palatin Technologies Inc. (NYSE:PTN) announced the presentation of topline results for its Phase 3 PL9643 MELODY-1 trial, which evaluated the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED) at the American Society of Cataract and Refractive Surgery.
週一，帕拉丁科技公司（紐約證券交易所代碼：PTN）在美國白內障和屈光外科學會公佈了其三期 PL9643 MELODY-1 試驗的主要結果，該試驗評估了 PL9643 與載體治療乾眼病（DED）的安全性和有效性。
The company released the mixed topline data in February 2024.
該公司於2024年2月發佈了喜憂參半的收入數據。
The presentation included MELODY-1 Phase 3 data results, which indicate that the Intent-to-Treat PL9643 treatment population demonstrated clinically meaningful and statistically significant results at the change from baseline to week 12 for the co-primary symptom endpoint of pain (p<0.025) and multiple exploratory secondary symptom endpoints.
該演示包括 MELODY-1 第 3 期數據結果，這些結果表明，在疼痛的共同主要症狀終點（p
The presentation also included an overview of the excellent and superior safety and tolerability profile of PL9643 compared to other approved treatments.
該演示還概述了 PL9643 與其他批准的治療方法相比具有出色和卓越的安全性和耐受性。
"Analysis of our successful Phase 3 MELODY-1 clinical trial results demonstrate that PL9643 has broad, robust, and rapid efficacy for multiple symptom endpoints. The efficacy results were statistically significant for the co-primary symptom endpoint of pain and 7 of 11 exploratory secondary endpoints, including eye dryness, as early as two weeks. The effect improved and maintained statistical significance over the 12-week treatment period," said Carl Spana, President and CEO of Palatin.
“對我們成功的 3 期 MELODY-1 臨床試驗結果的分析表明，PL9643 對多個症狀終點具有廣泛、穩健和快速的療效。早在兩週，疼痛的共同主要症狀終點和11個探索性次要終點中的7個（包括眼睛乾澀）的療效結果就具有統計學意義。在12周的治療期內，效果改善並保持了統計學意義。” 帕拉丁總裁兼首席執行官卡爾·斯帕納說。
"Additionally, we have identified a substantial patient population with statistically significant efficacy results after two weeks of treatment with PL9643 for multiple sign endpoints, including all four fluorescein staining endpoints, which improves ocular surface disorders and facilitates the identification and treatment of epithelial damage and corneal injuries."
“此外，對於包括所有四個熒光素染色終點（包括所有四個熒光素染色終點）的 PL9643 治療兩週後，我們已經確定了大量患者群體，其療效結果具有統計學意義，這有助於識別和治療上皮損傷和角膜損傷。”
"The early onset of efficacy for multiple symptoms and signs of dry eye disease and the excellent ocular safety and tolerability profile positions PL9643 as a highly differentiated product," Dr. Spana continued.
斯帕納博士繼續說：“乾眼病多種症狀和體徵的早期療效，以及出色的眼部安全性和耐受性，使 PL9643 成爲一種高度差異化的產品。”
Safety analysis from the Phase 3 MELODY-1 trial indicated PL9643 was well-tolerated.
MELODY-1 三期試驗的安全性分析表明，PL9643 耐受性良好。
There were fewer ocular treatment-related adverse events in the PL9643 arm (5.6%) compared to the vehicle (6.3%) and fewer study discontinuations in the PL9643 arm (7%) compared to the vehicle (11.1%).
與載體（6.3％）相比，PL9643 組中與眼部治療相關的不良事件較少（5.6％），與載體（11.1％）相比，PL9643 組中止的研究較少（7％）。
A higher proportion of the vehicle-treated patients dropped out of the study before week 12 compared to the PL9643-treated patients.
與接受PL9643治療的患者相比，在第12周之前退出研究的患者中，接受車輛治療的患者比例更高。
While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed, and less than 10% of those diagnosed are treated with a prescription product.
儘管DED是最常見的眼部疾病之一，在美國估計有3,800萬人受到影響，但只有大約1800萬人被診斷出來，而在被診斷的人中，只有不到10％的人接受處方藥治療。
The dry eye disease market is estimated at $6.11 billion in 2024 and is expected to reach $7.46 billion by 2029, growing at a CAGR of 4.09% during the forecast period (2024-2029).
乾眼病市場在2024年估計爲61.1億美元，預計到2029年將達到74.6億美元，在預測期（2024-2029年）內以4.09％的複合年增長率增長。
Price Action: PTN shares are up 33.1% at $2.34 on the last check Monday.
價格走勢：週一的最後一次支票中，PTN股價上漲33.1％，至2.34美元。
Photo by Gerax Sotelo on Unsplash
由 Gerax Sotelo 在 Unsplash 上拍攝的照片
譯文內容由第三人軟體翻譯。