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Alcon completed its acquisition of Aerie Pharmaceuticals. Through the transaction, Alcon has added the commercial products Rocklatan (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% and Rhopressa (netarsudil ophthalmic solution) 0.02%, as well as AR-15512, a Phase 3 product candidate for dry eye disease (DED). Alcon has also acquired a pipeline of ophthalmic pharmaceutical product candidates with the opportunity to leverage Aerie’s existing research and development capabilities. Alcon intends to fully integrate Aerie into its business.
- The FDA has accepted Apellis Pharmaceuticals’ unsolicited major amendment to the new drug application for intravitreal pegcetacoplan for the treatment of geographic atrophy secondary to AMD. The updated Prescription Drug User Fee Act goal date is Feb. 26, 2023.
- OKYO Pharma filed an investigational new drug (IND) application with the FDA for the development of OK-101 to treat DED. Both nonclinical and clinical development plans on OK-101 were reviewed with the FDA in an earlier Pre-IND meeting facilitated by OKYO’s contract research organization, Ora Inc., with the FDA agreeing to a first-in-human Phase 2 trial in DED patients. The FDA also concurred with OKYO’s plans for designating primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the trial’s clinical protocol.
- Sightpath Medical, a provider of mobile ophthalmic services for cataract and refractive surgery, has acquired Accusite Surgical, a mobile cataract surgical company that outsources equipment, technology, and certified staff to surgeons, ASCs, and hospitals. The strategic combination enhances Sightpath’s ability to deliver variable, tailored access to the expert personnel, equipment and supplies surgeons need to provide critical eye care.
- Kinarus Therapeutics announced the receipt of a Notice of Allowability from the United States Patent and Trademark Office for US Patent Application No. 16/500,504 "Methods of preventing or treating Ophthalmic Diseases" covering its therapeutic candidate KIN001 in AMD. The method of use patent is on top of granted US Patent No. 11285155 that protects the KIN001 pharmaceutical combination of pamapimod and pioglitazone until at least 2037. Kinarus is currently developing KIN001as an oral treatment for wet AMD, idiopathic pulmonary fibrosis and COVID-19.
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