Biotech firm developing potential treatment for rare eye disease called 'persistent corneal epithelial defect.'
Shares of Kala Pharmaceuticals surged Wednesday after the small biotechnology company announced a drug candidate for a rare eye disease.
The Food and Drug Administration has accepted Kala's investigational drug application for KPI-012, a potential treatment for persistent corneal epithelial defect, or PCED, the Arlington, Massachusetts-based company announced on Tuesday.
About 100,000 cases of PCED occur in the U.S. each year. The disease can lead to significant loss of vision, among other things, Kala stated. "We are now turning our focus to clinical execution," Brazzell said."We are working closely with investigators to initiate our Phase 2b clinical trial of KPI-012 for PCED in the first quarter of 2023."
If drug is cleared for use, it could become the first first approved treatment for PCED, according to Kala. The company expects to start enrolling patients in its trial in the first quarter of 2023 and to report preliminary results in early 2024.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
Kala Pharmaceuticals stock rockets after FDA accepts IND application for PCED treatmentShares of Kala Pharmaceuticals Inc. shot up 45.7% in premarket trading Wednesday, after the biopharmaceutical company said the Food and Drug Administration...
Lire la suite »
Two Sigma’s Perovic Expects AI to Drive More Biotech Innovation in 2023Advances in genomics, computing and automation generate biological data and insights for drugmakers, predicts partner at venture-capital firm.
Lire la suite »
U.S. FDA weighs regulating cannabis compound CBD in food, supplements - WSJAfter weighing the evidence on the compound's safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report. Cannabis products, excluding Jazz Pharmaceuticals PLC's Epidiolex, are illegal at the federal level in the United States, although some states allow their use. The agency wants to know if CBD can be safely eaten every day for a long period or during pregnancy amid concerns about future fertility, Patrick Cournoyer, who heads the FDA office developing the agency's cannabis strategy, told WSJ.
Lire la suite »
Blood pressure tablets recalled over potential cancer risk, FDA announcesThe FDA announced the second recall in months of blood-pressure medication over an elevated cancer risk. This time Quinapril tablets are being pulled.
Lire la suite »
Blood pressure tablets recalled over potential cancer risk, FDA announcesFour lots of the blood pressure medication Quinapril were voluntarily recalled over concerns it could increase the risk of cancer, the Food and Drug Administration said.
Lire la suite »
WSJ News Exclusive | FDA, Concerned About Safety, Explores Regulating CBD in Foods, SupplementsThe agency is studying whether cannabis-derived ingredients are safe in food and supplements and aims to reveal its oversight plans in the coming months.
Lire la suite »