Kala Reports Positive Results for Phase III Trial of KPI-121 for Post-Cataract Surgery Pain, Inflammation

May 12, 2017: By Jon Swedien

KalaA confirmatory Phase III trial for Kala Pharmaceuticals’ product candidate for post-cataract surgery pain and inflammation produced positive topline results, the Waltham, Massachusetts, company announced May 1.

KPI-121 is a novel nanoparticle formulation of loteprednol etabonate using Kala’s mucus-penetrating particle technology to enhance penetration into tissues of the eye.

The company said it intends to submit a new drug application to the US FDA in late 2017.

In the Phase III multicenter, randomized, double-masked trial of 520 patients, KPI-121 1% was dosed twice daily for two weeks and achieved statistical significance versus placebo for both primary efficacy endpoints and all secondary endpoints, Kala said.

The primary efficacy endpoints were the proportion of patients with complete resolution of anterior chamber cells—a marker of ocular inflammation—in the study eye at day eight, and the proportion of subjects with grade zero pain in the study eye at day eight, Kala said.

Secondary endpoints were complete resolution of anterior chamber flare at day four, complete resolution of pain at day four, and mean change in anterior chamber cells at day four. Each case maintained through day 15 with no need for rescue medication, Kala said.

The positive results followed Kala’s first Phase III trial for KPI-121 1% for post-cataract surgery pain and inflammation that concluded in 2015. In 380 patients, the treatment achieved complete resolution of ocular pain by the eighth day of treatment.

Kala also is studying KPI-121’s effectiveness as a proposed dry eye treatment in a pair of Phase III trials, expected to be completed by the end of 2017.

 

Need Deeper Analysis? Sign up for Market Scope's monthly newsletter to get in-depth coverage of the ophthalmic market, including quarterly procedure volumes based on survey data and meeting coverage from around the world.

Recent Ophthalmic News

Eylea Gains Approval in China for DME-Related Visual Impairment

Second Trial for Ophthalmic Industry Leader James Mazzo Ends in Hung Jury, Mistrial

Melgen Receives 17-Year Sentence for Medicare Fraud

NIH’s National Eye Institute Solicits Next-Generation Retina Organoids in $1 Million Prize Competition

Taiwan Liposome Company Registers for $50 Million IPO in US

US FDA Approves Icon Bioscience’s DEXYCU for Post-Cataract Surgery Inflammation

FDA’s Gottlieb Appears to Soften Stance on Compounding for Office Use

Genentech’s RG7716 Outperformed Ranibizumab in Phase II Study in Diabetic Macular Edema

Santen Reports Promising Data in Phase I/II Study in Refractory Wet AMD

Q Biomed Signs Agreement with Washington University for Novel Biomarker for Monitoring Glaucoma

pSivida’s Durasert for Posterior Segment Uveitis Yields Positive 12-Month Results in Second Phase III Study

Foundation Fighting Blindness Provides $7.5 Million to Help Develop ProQR’s Candidate for Usher Syndrome

Presbia Names Casey Lind as Chief Operating Officer, Magda Michna, MD, PhD, as Chief Clinical Officer

Astellas Acquires Universal Cells

Pixium Vision Completes Two Successful PRIMA Implantations in Atrophic Dry AMD Patients

Omeros Loses Pass-through Status for Omidria

USC Donations Drop $100 Million after Puliafito Scandal, Report Says

Regeneron’s US Eylea Sales Increase 14 Percent in Q4-2017

Allergan’s Net Sales Climb 12 Percent in Q4-2017; Restasis Sales Grow Nearly 1 Percent

Lucentis’ US Sales Drop 11 percent in Q4-2017, Grow 1 Percent for Full 2017

Coming soon

2018 Retinal Surgical Devices Report: A Global Market Analysis for 2017 to 2023