We remind investors that the FDA earlier issued a complete response letter (CRL) to the company's biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wAMD, DME and DR. The cause of the CRL was only an ongoing review of inspection findings at a third-party filler and the FDA did not request any additional clinical data or studies. The approval of Eylea HD will relieve investors somewhat, as Eylea sales have been under pressure in the last couple of quarters due to competition from Roche's Vabysmo and sale deductions. Regulatory filings for aflibercept 8 mg are under review in Europe and Japan. Submissions to other regulatory authorities in additional countries are also planned. Please note that Regeneron co-developed Eylea with Bayer AG ( BAYRY - Free Report ).