Breaking News
September 22, 2018 - Brigham Genomic Medicine program unravels 30 medical mysteries
September 22, 2018 - New system harnesses power of bubbles to destroy dangerous biofilms
September 22, 2018 - Inflammation plays crucial role in preventing heart attacks and strokes, study reveals
September 22, 2018 - Calorie dense, nutrient deficient meals common across the world
September 22, 2018 - Researchers develop technology to study behavior of implants without animal testing
September 22, 2018 - First gut bacteria in newborns may have lasting effect on ability to ward off chronic diseases
September 22, 2018 - Detection of BFD virus in parrots in 8 new countries raises concerns for threatened species
September 22, 2018 - Insulin treatment shows great potential against chronic bowel inflammation
September 22, 2018 - ‘Liking Gap’ Might Stand in Way of New Friendships
September 22, 2018 - Simple factors that can avoid harmful side effects in type 2 diabetes
September 22, 2018 - ALSAM Foundation invests additional $2 million for drug discovery and development projects
September 22, 2018 - Study findings may advance discussion of how to effectively curb human-wildlife conflict
September 22, 2018 - Dopamine neurons may involve in conditions ranging from Parkinson’s disease to schizophrenia
September 22, 2018 - Protein C and Protein S Tests: MedlinePlus Lab Test Information
September 22, 2018 - Obesity and diabetes—two reasons why we should be worried about the plastics that surround us
September 22, 2018 - Concern over fussy eating prompts parents to use non-responsive feeding practices
September 22, 2018 - Novel mathematical approach uncovers existence of unsuspected biological cycles
September 22, 2018 - Cancer Research UK invests £14 million to transform London into cancer biotherapeutics hub
September 22, 2018 - Scientists predict how well the body will fight lung cancer by analyzing immune cell shapes
September 22, 2018 - New outbreak of rare eye disease identified in contact lens wearers
September 22, 2018 - Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections
September 22, 2018 - Research finds divide in dental health accessibility between city and regional areas
September 22, 2018 - Premature babies show better brain development when fed breast milk, finds study
September 22, 2018 - Novel system uses AI to detect abnormalities in fetal hearts
September 22, 2018 - UNC scientists reveal new approach to prevent obesity and diabetes
September 22, 2018 - CWRU receives NIH grant to learn how non-coding genes contribute to spread of colorectal cancer
September 22, 2018 - Scientists better understand influenza virus and how it spreads
September 22, 2018 - Scientists to focus on length of time when a person is alive and healthy
September 22, 2018 - Study shows positive financial impacts of Medicaid expansion for low-income Michigan residents
September 22, 2018 - Innovative approach for developing vaccine against most prevalent human malaria parasite
September 22, 2018 - Survey estimates caregiving costs for family members
September 22, 2018 - Inhibiting NF-kB improves heart function in a mouse model of Duchenne muscular dystrophy
September 22, 2018 - Introducing new EMR system may affect several aspects of clinic workflow
September 22, 2018 - Study finds why some human genes are more popular with biomedical researchers
September 22, 2018 - Finding epigenetic signature appears to predict inflammation risk in serious type of IBD
September 22, 2018 - Researchers develop light-based technique to measure very weak magnetic fields
September 22, 2018 - UAB researchers study dysfunction of the immune system associated with NSAID carprofen
September 22, 2018 - QIAGEN and DiaSorin launch automated, CE-marked workflow for high-throughput TB screening
September 22, 2018 - EFS checklist provides user-friendly tool for evaluating feeding skills in preterm infants
September 22, 2018 - Family history in blacks, Latinos associated with higher risk of AFib
September 22, 2018 - Researchers identify new genetic disorder in a human patient
September 22, 2018 - Cardiac MR With Contrast Feasible in Developing World
September 22, 2018 - Daily low-dose aspirin doesn’t reduce heart-attack risk in healthy people
September 21, 2018 - Children with asthma found to be disadvantaged in education and future occupation
September 21, 2018 - Interaction of chemical slurry and ancient shale in fracking wastewater causes radioactivity
September 21, 2018 - Scientists use mice to study transmission of Lyme disease bacteria by infected ticks
September 21, 2018 - Researchers find that sample size is key factor determining accuracy of study results
September 21, 2018 - Study shows how the drive to eat overpowers the brain’s signal to stop
September 21, 2018 - 30 Million Americans Now Have Diabetes
September 21, 2018 - Thousands of breast cancer gene variants engineered and analyzed
September 21, 2018 - The current fellowship interview process is cumbersome — Stanford researchers have a better idea
September 21, 2018 - Progenitor cells for human bone and cartilage have been identified
September 21, 2018 - Study reveals new therapeutic target for pediatric tumor-associated intractable epilepsy
September 21, 2018 - SLU’s College professor receives NIH grant to develop I-TEST project
September 21, 2018 - DermTech completes enrollment in clinical study to assess DNA damage and reversal
September 21, 2018 - Grieving patients treated with talk therapy have lower risk of suicide and psychiatric illness
September 21, 2018 - NIH and FDA call for eliminating involvement of RAC in human gene therapy experiments
September 21, 2018 - New system uses algorithm to convert 2D videos into 3D printed ‘motion sculptures’
September 21, 2018 - Sea squirt model reveals key molecules in dopaminergic neuron differentiation
September 21, 2018 - Effective management of neonatal abstinence syndrome requires coordinated ‘cascade of care’
September 21, 2018 - Refugees seek care for wounds of war
September 21, 2018 - Under the sea, in an octopus’ garden on ecstacy
September 21, 2018 - Eating foods with low nutritional quality ratings linked to cancer risk in large European cohort
September 21, 2018 - Giving kids honest information about water consumption may help them make healthy choices
September 21, 2018 - Horwitz Prize Awarded for Work on Hormones
September 21, 2018 - CHMP issues positive opinion supporting use of Trelegy Ellipta in broader group of COPD patients
September 21, 2018 - Scientists discover new molecules that work together to remove unwanted DNA
September 21, 2018 - Dr. Fenella France to deliver 2019 Plenary Lecture
September 21, 2018 - New research finds that MHC-II molecules have more influence on tumors than MHC-I
September 21, 2018 - Researchers study effects of cardiac cycle in simple learning task
September 21, 2018 - FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy
September 21, 2018 - Positive Barhemsys Phase 3 Treatment Data Published in Anesthesia & Analgesia
September 21, 2018 - Celiac Disease Screening: MedlinePlus Lab Test Information
September 21, 2018 - Autism linked to egg cells’ difficulty creating large proteins
September 21, 2018 - Tweaking nuclear pores could provide new avenue to battle against cancer
September 21, 2018 - Experts warn health care providers to slow down in allowing smart pill in patient care settings
September 21, 2018 - MoreGrasp reports breakthrough development of grasp neuroprosthetics activated by thought control
September 21, 2018 - Study reveals new way to target HER2-negative metastatic breast cancer
September 21, 2018 - CHMP grants positive opinion for VENCLYXTO plus rituximab for treating relapsed/refractory CLL
September 21, 2018 - Study offers solid link between visceral organs and brain’s reward, motivation system
Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)

Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)

image_pdfDownload PDFimage_print
Treatment for Postoperative Ocular Inflammation

Kala Pharmaceuticals Submits NDA to U.S. Food And Drug Administration for Inveltys (KPI-121 1%)

WALTHAM, Mass.–(BUSINESS WIRE)–Oct. 25, 2017– Kala Pharmaceuticals, Inc. (NASDAQ:KALA) today announced that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for Inveltys (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery. If approved, Kala expects Inveltys would be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain. The brand name for KPI-121 1%, Inveltys, has been conditionally approved by the FDA.

Inveltys utilizes Kala’s proprietary Mucus Penetrating Particle (MPP) technology. MPPs are selectively-sized nanoparticles with proprietary coatings that significantly enhance drug penetration and distribution in ocular tissues. In pre-clinical studies, MPPs increased delivery into ocular tissues more than three-fold by facilitating penetration through the tear film mucus.

“Inveltys administered twice-a-day to patients following cataract surgery demonstrated statistically significant resolution of both inflammation and pain in each of two Phase 3 clinical trials,” said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. “Based on these results, as well as its safety profile and twice-daily dosing, we believe that Inveltys would be a valuable treatment option for doctors and patients.”

The NDA filing is supported by positive data from two Phase 3 trials. The first Phase 3 clinical trial was designed to evaluate Inveltys administered twice-a-day and KPI-121 0.25% administered four times a day for 14 days following cataract surgery. Statistical significance was achieved for the primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications compared to placebo with both Inveltys and KPI-121 0.25%. In May 2017, Kala announced topline results from the second, confirmatory Phase 3 clinical trial with Inveltys. Compared to placebo, administration of Inveltys twice-a-day for 14 days achieved statistical significance for both primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications and all secondary endpoints. Inveltys was found to be well tolerated with no treatment-related serious adverse events observed during the course of either trial.

“The filing of the NDA for Inveltys marks a major milestone for Kala in advancing our mission of developing treatments for eye conditions using our MPP technology,” said Mark Iwicki, Chairman and Chief Executive Officer of Kala Pharmaceuticals. “We believe that our MPP technology has the potential to not only improve the post-operative care of patients undergoing ocular surgery, but also help advance care in other ophthalmic indications such as dry eye disease using our KPI-121 0.25% product candidate. We expect to receive topline results from the Phase 3 clinical program for KPI-121 0.25% in patients with dry eye disease by the end of 2017.”

About Post-Operative Inflammation and Pain

Ocular inflammation and pain are common complications following ocular surgery. According to Marketscope, in 2016 there were 7.7 million ocular surgeries in the United States, which is projected to grow to up to 9.4 million in 2021. More than half of the ocular surgeries performed in the U.S. are cataract surgeries. Tissue damage caused by ocular surgery leads to the production of prostaglandins, lipids that aid in recovery at the site of an injury, and an increase in blood flow to the affected area, both of which contribute to inflammation. The standard of care for post-operative inflammation and pain includes anti-inflammatory drugs such as corticosteroids, which improve patient comfort and accelerate recovery through disruption of the inflammatory cascade. The current four-times-a-day dosing regimen for corticosteroid treatment can be burdensome for patients as they are taking multiple eye drop products following surgery, and is believed to reduce patient compliance. There are no twice-daily ocular corticosteroid products currently approved in the U.S. for the treatment of post-operative inflammation and pain.

About Inveltys (KPI-121 1%)

Inveltys (KPI-121 1%) is a twice-a-day corticosteroid for the treatment of inflammation and pain following ocular surgery. Inveltys utilizes Kala’s proprietary Mucus-Penetrating Particle (MPP) technology to enhance penetration into target tissues of the eye. In pre-clinical studies, MPP increased delivery of a corticosteroid into ocular tissues more than three-fold by facilitating penetration through the tear film mucus. Inveltys has successfully completed two Phase 3 clinical trials and achieved statistical significance for both primary efficacy endpoints in both trials. Kala believes Inveltys has a favorable treatment profile compared to the standard of care for the treatment of inflammation and pain following ocular surgery, due to its twice-a-day dosing regimen and rapid onset of relief. In each of these trials, Inveltys was well tolerated with no treatment-related serious adverse events observed.

About Kala Pharmaceuticals, Inc.

Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary Mucus-Penetrating Particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two product candidates in Phase 3 clinical development, Inveltys (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties including statements regarding the development and regulatory status of the company’s product candidates, including Inveltys (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. All statements, other than statements of historical facts, contained in this press release, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. For a discussion of the risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in our Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Source: Kala Pharmaceuticals, Inc.

Posted: October 2017

Inveltys (loteprednol etabonate) FDA Approval History

Tagged with:

About author

Related Articles