EYEN - Earnings announcements

Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for interim analysis this quarter Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device Announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery Appointed Andrew Jones as Chief Financial Officer Company to host conference call and webcast today, November 12th, at 4:30 pm ET NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company developing and commercializing adv

NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced that the Company will release financial results for the third quarter ended September 30, 2024 on Tuesday, November 12th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international) and reference Conference ID# 13748714. To access t

Following FDA consultation, announced plans for validation of the Gen-2 Optejet® device and 2025 regulatory submission with Mydcombi™ as lead product Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4 Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years Announced development collaborations with Formosa, Senju and SGN to leverage the Optejet for the $5 billion global dry eye disease market Company to host conference call and webcast today, August 12th, a

NEW YORK, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will release financial results for the second quarter ended June 30, 2024 on Monday, August 12th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international) and reference Conference ID# 13747356. To access the Call me™ feature, which avoids having to wait for an operat

Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the fi

NEW YORK, May 14, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that the Company will release financial results for the first quarter ended March 31, 2024 on Wednesday, May 15th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-800-717-1738 (domestic) or 1-646-307-1865 (international). To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of

Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery Reacquired development and commercialization rights to MicroPine for progressive pediatric myopia in the U.S. and Canada Continued to advance commercial operations with launch of Mydcombi™, FDA approval of manufacturing facility, onboarding of sales organization and signing of copromotion agreement Company to host conference call and webcast today, March 18th, at 4:30 pm ET NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today announced its financial and operating results for the

NEW YORK, March 11, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic pharmaceutical technology company, today announced that the Company will release financial results for the fourth quarter ended December 31, 2023 on Monday, March 18th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international) and referencing conference ID 13744365. To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of the conferen

Approval based on nearly 9 out of 10 patients achieving complete absence of post-surgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post-ocular surgery Eyenovia plans to launch in the U.S. as soon as this summer using its Mydcombi™ sales force providing pre-surgical pupil dilation and post-surgical care in an estimated $1.3 billion annual U.S. market NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today congratulates Formosa Pharmaceuticals (TWO:6838) on the FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of post-operative inflammation and pain following

Acquired U.S. commercial rights to APP13007, currently under FDA review for post-surgical ocular pain and inflammation, from Formosa Pharmaceuticals Announced FDA approval of Coastline International as contract manufacturer for Mydcombi cartridge subassemblies and preparations for national launch Company to host conference call and webcast today, November 13th, at 4:30 pm ET NEW YORK, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage, topical ophthalmic company leveraging its Optejet® dispensing technology for both internally developed and acquired programs as well as out-licensing for additional indications, today announced its financial and opera

NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company commercializing Mydcombi™ for mydriasis, preparing for regulatory approval of APP13007 for relief of pain and inflammation post ocular surgery, and incorporating its advanced Optejet® device with late-stage product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the Company will release financial results for the third quarter ended September 30, 2023 on Monday, November 13, 2023, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ED

Announced FDA approval of and first commercial sale of Mydcombi™, the only fixed dose combination of tropicamide and phenylephrine for mydriasis and the first FDA approved product to utilize the Optejet® Continued to advance its Phase 3 Apersure™ (Microline) presbyopia candidate following receipt of guidance from FDA that establishes an efficient path forward for the program Company to host conference call and webcast today, August 10, at 4:30 pm ET NEW YORK, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company commercializing Mydcombi™ (tropicamide+phenylephrine ophthalmic spray) for mydriasis and developing the Optejet® device for use both i

Announced FDA approval of Mydcombi™, a fixed dose combination of tropicamide and phenylephrine for mydriasis, the first FDA approved product to utilize the Optejet® Received feedback from FDA on its Phase 3 Microline presbyopia candidate that provides a clear and efficient path forward for the program Entered into co-development agreement with Formosa Pharmaceuticals for the potential development of new topical ophthalmic therapeutics Company to host conference call and webcast today, May 11, at 4:30 pm ET NEW YORK, May 11, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company developing the Optejet delivery system for use both in combination

Represents the first FDA approved fixed-combination of tropicamide and phenylephrine for mydriasis Provides critical validation of key technology that is core to Eyenovia's proprietary development programs as well as current and future partnerships NEW YORK, May 08, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic technology company developing the Optejet® device for use both in connection with its own drug-device therapeutic product candidates for presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced that the U.S. Food and Drug Administration (FDA) has approved Mydcombi (tropicamide and phenylephrine hydrochl

NEW YORK, May 04, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications, today announced that the Company will release financial results for the first quarter ended March 31, 2023 on Thursday, May 11, 2023, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. EDT to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international). A live webcast of

Announced FDA acceptance of Mydcombi New Drug Application (NDA) and PDUFA action date of May 8, 2023 Announced positive results from Microline Phase 3 program as a potential treatment for presbyopia and received feedback from the FDA outlining a clear path forward for the program Entered into co-development agreement with Formosa Pharmaceuticals Company to host conference call and webcast today, March 30th, at 4:30 pm ET NEW YORK, March 30, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pe

NEW YORK, March 23, 2023 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications, today announced that the Company will release financial results for the fourth quarter and full year ended December 31, 2022 on Thursday, March 30, 2023, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international

Announced positive results from the second Phase 3 study of MicroLine in presbyopia, VISION-2; Company planning to meet with the FDA to gain alignment on regulatory path forward as a drug/device combination product Company to host conference call and webcast today, November 10, at 4:30 pm ET NEW YORK, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for

NEW YORK, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs as well as out-licensing for additional indications, today announced that the Company will release financial results for the third quarter ended September 30, 2022 on Thursday, November 10, 2022, after the markets close. Following the release, Eyenovia management will host a conference call to review the financial and operating results. The conference call is scheduled to begin at 4:30pm ET on Thursday, November 10, 2022. Participants should dial 1-866-5

Announced appointment of Michael Rowe as Chief Executive Officer and Board member Mydcombi™ NDA resubmission on track for the fourth quarter of 2022 Phase 3 VISION-2 study evaluating MicroLine as an on-demand treatment for improving near vision (presbyopia) progressing as planned; topline data expected in the third quarter of 2022 Company to host conference call and webcast today, August 10, at 4:30 pm ET NEW YORK, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial and ope

NEW YORK, Aug. 04, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, announced that the Company will release financial results for the second quarter ended June 30, 2022 on Wednesday, August 10, 2022, after the markets close. Following the release, Eyenovia management will host a conference call to review the financial and operating results. The conference call is scheduled to begin at 4:30pm ET on Wednesday, August 10, 2022. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international) with the conference code 13731733. A live webcast of the conf

Mydcombi™ NDA resubmission on track for Q3 2022 Phase 3 VISION-2 study evaluating MicroLine as an on-demand treatment for improving near vision (presbyopia) progressing as planned; topline data expected mid-year Ended Q1 with sufficient cash and cash equivalents for the potential launch of Mydcombi and completion of the VISION program Company to host conference call and webcast today, May 12, at 4:30pm ET NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial and operating results fo

NEW YORK, May 05, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, announced that the Company will release financial results for the first quarter ended March 31, 2022 on Thursday, May 12, 2022, after the markets close. Following the release, Eyenovia management will host a conference call to review the financial and operating results. The conference call is scheduled to begin at 4:30pm ET on Thursday, May 12, 2022. Participants should dial 1-877-207-9876 (domestic) or 1-212-231-2932 (international) with the conference code 22018217. A live webcast of the conference ca

Successfully completed Type A meeting with FDA and anticipates MydCombi™ NDA resubmission in Q3 2022 Enrolled first patient in the Phase 3 VISION-2 study evaluating MicroLine as an on-demand treatment for improving near vision (presbyopia) Entered into a $15 million Securities Purchase Agreement with Armistice Capital to support the Company's clinical and manufacturing operations Company to host conference call and webcast today, March 28, at 4:30pm ET NEW YORK, March 28, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, toda

NEW YORK, March 21, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, announced that the Company will release financial results for the fourth quarter and full year ended December 31, 2021 on Monday, March 28, 2022, after the markets close. Following the release, Eyenovia management will host a conference call to review the financial and operating results. The conference call is scheduled to begin at 4:30pm ET on Monday, March 28, 2022. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international) with the conference code 13727374. A live webcast of t

NEW YORK, Feb. 08, 2022 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that the company successfully completed a Type A meeting with the U.S. Food and Drug Administration (FDA) related to the refiling of the NDA for MydCombi. On October 22, 2021, Eyenovia received a complete response letter (CRL) from the FDA stating that MydCombi, the company's proprietary, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation, had been reclassified as a drug-device combination product. Following the recent Type A meeting, Eyenovia a

On track with VISION-2 phase 3 presbyopia trial and expedited resubmission of MydCombi™ New Drug Application as a drug/device combination in early 2022 Current cash resources anticipated to be sufficient to cover MydCombi NDA resubmission, completion of Phase 3 MicroLine program, and completion of manufacturing facility Company to host conference call and webcast tomorrow, November 11, at 5:00pm ET NEW YORK, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial results for the third quarter

Eyenovia will release third quarter 2021 results on Wednesday, November 10, after the close. The prior version of this press release incorrectly stated that third quarter 2021 results would be released on Thursday, November 11, after the close. Company to host an investor conference call and webcast on Thursday, November 11 at 5:00pm ET NEW YORK, Nov. 05, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, announced that the Company will release financial results for the third quarter ended September 30, 2021 on Wednesday, November 10, 2021, after the market close. E

NEW YORK, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print (MAP™) therapeutics, announced that the Company will release financial results for the third quarter ended September 30, 2021 on Thursday, November 11, 2021, after the market close. Following the release, Eyenovia management will host a conference call to review the financial and operating results and provide a business update. The conference call is scheduled to begin at 5:00pm ET on Thursday, November 11, 2021. Participants should dial 877-407-9039 (domestic) or 201-689-8470 (international) with the conference code 13724

Announced positive topline data from its Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia Company on track to initiate second Phase 3 presbyopia trial, VISION-2, by year-end 2021 MydCombi PDUFA date confirmed for October 28, 2021 Company to host conference call and webcast today, August 11, at 4:30pm ET NEW YORK, Aug. 11, 2021 (GLOBE NEWSWIRE) --  Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial and operating results for the second quarter ended June 30, 2021. Second Quarter 2021 and Recent B

NEW YORK, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, announced that the Company will release financial results for the second quarter ended June 30, 2021 on Wednesday, August 11, 2021, after the market close. Following the release, Eyenovia management will host a conference call to review the financial and operating results. The conference call is scheduled to begin at 4:30pm ET on Wednesday, August 11, 2021. Participants should dial 855-327-6837 (domestic) or 631-891-4304 (international) with the conferenc

MydCombi PDUFA date confirmed for October 28, 2021 Completed patient enrollment in Phase 3 VISION-1 study evaluating MicroLine for the treatment of presbyopia; top-line data on track for Q2 Secures $25 million credit facility through Silicon Valley Bank Company to host conference call and webcast today, May 12, at 4:30pm ET NEW YORK, May 12, 2021 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its proprietary microdose array print (MAP™) platform technology, today announced its financial results for the first quarter ended March 31, 2021. First Quarter 2021 and Recent Business Highlights U.S