Surface Ophthalmics, Inc. has announced positive top-line results from the Phase II trial for SURF-201, an investigational therapy for the treatment of post-cataract surgery pain and inflammation. With twice-daily dosing, SURF-201 met its primary endpoints of absence of inflammation at both Day 8 and Day 15.
SURF-201 is 0.2% betamethasone, a unique and potent corticosteroid, formulated as a solution in Surface's patented Klarity vehicle, and is intended to provide improved efficacy and safety when compared to currently used corticosteroids. SURF-201 marks the first ophthalmic therapeutic in the United States to utilize betamethasone, as well as being the first preservative-free unit dose therapy for the treatment of post-operative pain and inflammation.
The trial involved 91 patients and met the primary endpoints of complete clearance of anterior chamber cells, which is a marker for inflammation, at both Day 8 and Day 15 with p-values of 0.01 and 0.001, respectively. While SURF-201 was dosed at only twice per day, a higher percentage of patients were inflammation free by the end of the dosing when compared to the previously reported results of all other branded corticosteroids. In addition to inflammation, when looking at the secondary endpoint, an unprecedented high percentage of almost 90% of patients were pain-free at Day 15. Overall, SURF-201 was found to be safe and well-tolerated and there was zero incidence of intraocular pressure increase of more than 10 mm/Hg from the base and exceeding the 22 mm/Hg mark.
"The extremely positive data for SURF-201 affirms not only the potential for this product, but also the merit of the common building blocks found across the therapies in our pipeline," said Kamran Hosseini, MD, PhD, President and CEO, Surface Ophthalmics. "This is a critical point in time for Surface Ophthalmics – over the coming months, we will be moving forward with SURF-201 as well as advancing our pipeline of SURF-100 (Chronic Dry Eye) and SURF-200 (Episodic Dry Eye) into Phase II trials. Based on the data we received from this study, we feel even more confident that our building block approach to product development will continue to demonstrate positive results and allow us to fully recognize the potential of our robust pipeline to offer innovative solutions for unmet patient needs in the ophthalmic space."
"These results are, to me, extremely promising – showing impressive reduction in pain and inflammation – giving us strong Phase II evidence that SURF-201 has benefits for patients following ocular surgery," said Richard Lindstrom, MD, internationally recognized leader in corneal, cataract, refractive and laser surgery. "With SURF-201, I'm excited to see betamethasone, a potent and safe corticosteroid popular in many countries, advance through clinical trials in the United States. I expect SURF-201 to be a significant new treatment option for the eyecare community, particularly in its unique unit-dose, preservative-free solution with the comforting Klarity vehicle."
Full press release: surfaceophthalmics.com/news/
Source: Surface Ophthalmics