Formosa Pharmaceuticals announces top-line results from Chinese trial evaluating APP13007

Author(s):

Martin David Harp

Key Takeaways

APP13007, a clobetasol propionate nanosuspension, showed superior efficacy in resolving post-cataract surgery inflammation and pain compared to placebo in a Chinese phase 3 trial.
The study's primary endpoints were met, with 91.2% of APP13007 subjects pain-free by day 4, significantly outperforming placebo.
APP13007 is approved in the US, with Eyenovia holding commercial rights, and Apotex Inc. in Canada, while Grand Pharma will commercialize it in China.
The trial results in China are consistent with previous US studies, supporting a successful commercial launch in the Chinese market.

The phase 3 trial was conducted by licensee, Grand Pharma in Chinese cataract surgery patients.

(Image Credit: AdobeStock)

Formosa Pharmaceuticals has announced the completion and top-line results from CPN-303, a phase 3 clinical study of APP13007 (GPN00833), conducted in Chinese cataract surgery patients by licensee, Grand Pharma (0512.HK).

APP13007 is a novel ophthalmic nanosuspension formulation of the potent corticosteroid, clobetasol propionate (0.05%), and was recently approved and launched in the United States for the treatment of post-operative inflammation and pain following ocular surgery.

Grand Pharma obtained exclusive rights from Formosa in 2021 for the commercialization of APP13007 in Mainland China, Hong Kong and Macau.¹ Eyenovia has the US commercial rights of the drug, which were acquired last August from Formosa, while Apotex Inc. has exclusive commercial rights in Canada.

CPN-303 is a randomized, double-blind trial in China that evaluating APP13007 against matching placebo (2:1 ratio) in 255 subjects following cataract surgery.¹ The primary endpoints were complete and sustained resolution of ocular inflammation and pain after cataract surgery, like the CPN-301 and CPN-302 phase 3 studies completed in the United States in 2022.¹

According to the company, treatment with an APP13007 eyedrop twice daily for 14 days achieved both primary endpoints by “producing rapid and sustained clearance of ocular inflammation and cure of ocular pain which were clinically and statistically superior to placebo.” Furthermore, 91.2% of subjects on APP13007 were free of ocular pain by post-operative day 4 and remained pain-free through post-operative day 15, compared to only 55.3% of subjects taking placebo (p<0.001).¹

Erick Co, PhD, president and CEO of Formosa Pharmaceuticals, commented on the results in a press release from the company stating, "Formosa Pharma congratulates our partners at Grand Pharma on their successful and swift execution of this Phase 3 study in Chinese patients. We are pleased to note that the results of their trial are consistent with observations and outcomes of our United States trials. We look forward to working with Grand Pharma toward their commercial launch in China."

References:

Formosa Pharmaceuticals Announces Successful Top-Line Results from CPN-303, a Phase 3 Trial in Chinese Subjects for the Treatment of Inflammation and Pain after Cataract Surgery. Press Release; November 4, 2024. Accessed November 6, 2024. https://www.prnewswire.com/news-releases/formosa-pharmaceuticals-announces-successful-top-line-results-from-cpn-303-a-phase-3-trial-in-chinese-subjects-for-the-treatment-of-inflammation-and-pain-after-cataract-surgery-302295164.html