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The investigational therapy met all primary endpoints of absence of inflammation at both Day 8 and Day 15 for the treatment of pain and inflammation following cataract surgery.
Surface Ophthalmics Inc. has announced positive top-line results from the Phase II trial for betamethasone 0.2% (SURF-201), an investigational therapy for the treatment of post-cataract surgery pain and inflammation.
With twice-daily dosing, betamethasone 0.2% met its primary endpoints of absence of inflammation at both Day 8 and Day 15, according to the report.
Betamethasone 0.2% is a 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. The drug 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 betamethasone 0.2% 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, betamethasone 0.2% 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 affirms not only the potential for this product, but also the merit of the common building blocks found across the therapies in our pipeline,” Kamran Hosseini, MD, PhD, president and CEO of Surface Ophthalmics, said in a statement.
According to Hosseini, based on the date, the drugmaker is confident that its building block approach to product development will continue to demonstrate positive results and allow it to fully recognize the potential of its pipeline to offer innovative solutions for unmet patient needs in the ophthalmic space.
Surface Ophthalmics is advancing three clinical programs: one in chronic dry eye disease (SURF-100), one in episodic dry eye disease (SURF-200), and one in pain and inflammation following ocular surgery (SURF-201). These programs utilize Klarity as the delivery vehicle, which has a proven track record of protecting and rehabilitating the ocular surface.