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Lipocine Announces Presentations at the 21st Annual Fall Meeting of the Sexual Medicine Society of North America

SALT LAKE CITY, Oct. 14, 2020 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present results from studies suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men as well as the safety and efficacy of TLANDO™, an oral testosterone replacement therapy without a dose titration requirement, at the 21st Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (“SMSNA”). Lipocine will outline the possible mechanisms and clinical evidence that suggests men with low testosterone have poor COVID-19 outcomes, and the rationale of using an oral testosterone therapy for men with COVID-19. Results from the previously completed dose validation (“DV”) study of a fixed dose TLANDO in hypogonadal males will also be presented at the meeting.  The presentations will take place virtually on November 9, 2020 from 7:00 p.m.9:00 p.m. EST during Session 2 (Androgens and Ejaculation/Orgasm Disorders). 

https://www.smsna.org/V1/2020/program/scientific-program?where_person=44
https://www.smsna.org/V1/2020/program/scientific-program?where_person=42

“We know that while COVID-19 infection rates are comparable between men and women, men are developing severe symptoms and dying at a significant higher rate than women. Furthermore, men with comorbidities commonly associated with lower testosterone are at greater risk for severe disease and death,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc.  “The presentation on COVID-19 highlight key clinical evidences suggesting that low testosterone levels may play an important role on the clinical outcomes of COVID-19 in men. Based on the published data, the use of oral testosterone with the goal of achieving physiological testosterone levels should be evaluated in clinical trials of COVID-19.”

Dr. Anthony DelConte, Chief Medical Director of Lipocine further stated, “TLANDO will be the first oral testosterone for treatment hypogonadism without titration requirement. It is expected to be easy to prescribe and use.” Dr. DelConte added, “The SMSNA presentation on TLANDO highlights the key safety and efficacy data from multiple clinical studies supporting TLANDO’s ability to effectively restore testosterone levels in hypogonadal men without need for any dose adjustment.”

Is Oral Testosterone a Potential Treatment for COVID-19 in Men? (Benjamin J. Bruno et al)

The authors performed a literature search to understand the possible mechanisms and clinical evidence concerning testosterone levels in COVID-19 patients.  A recent clinical study investigating testosterone levels in men with COVID-19 found 80% of men who died due to COVID-19 had low total or bioavailable testosterone levels at the time of hospital admission. Those with severe Acute Respiratory Distress Syndrome (“ARDS”) had acutely depressed total testosterone compared to patients who did not exhibit severe ARDS. The mean total testosterone levels for men who required invasive ventilation was 29 ng/dL (normal range ~300-1100 ng/dL), whereas those who were discharged from the ICU had mean total T of 254 ng/dL at the time of ICU admission.

In comparison to other routes of testosterone administration, oral testosterone therapy may be the most convenient and suitable for acute treatment of COVID-19 in

Eyenovia to Present Clinical Study Updates at the American Academy of Optometry Annual Meeting

Optometry and ophthalmology doctors to present latest analyses and updates from studies of its MAP therapeutics for mydriasis, pediatric myopia and presbyopia

Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics, today announced that Drs. Siddarth Rathi and April Jasper will present the latest analyses and updates from the company’s clinical studies at the American Academy of Optometry Academy 2020 At Home Con.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201005005232/en/

On Wednesday, October 7, April Jasper, OD, medical monitor for the company’s CHAPERONE study and member of the Eyenovia Scientific Advisory Board, will provide pre-recorded updates on the CHAPERONE (evaluation of low-dose atropine for the reduction of pediatric myopia progression) and the VISION (evaluation of low-dose pilocarpine for improvement in near vision) clinical trials. Dr. Jasper will also provide an update on the company’s upcoming Mydcombi (low-dose tropicamide and phenylephrine fixed combination for pupil dilation) NDA filing with the U.S. Food and Drug Administration (FDA).

On Thursday, October 8 at 6 p.m. EDT, Siddarth Rathi, MD, of The Eye Institute of West Florida and medical monitor for the MIST 1 and MIST 2 studies, will present additional analyses of data from the MIST 1 and MIST 2 studies of Eyenovia’s proprietary first-in-class fixed combination microdose formulation of phenylephrine and tropicamide for mydriasis (pupil dilation). Clinical results will cover Pupil Dilation Speed with MAP™ Fixed Combination (FC) Tropicamide 1% Phenylephrine 2.5% (TR-PH)-Ophthalmic Solution.

About Eyenovia

Eyenovia, Inc. (NASDAQ: EYEN) is a clinical stage ophthalmic biopharmaceutical company developing a pipeline of microdose array print (MAP™) therapeutics. Eyenovia’s pipeline is currently focused on the late-stage development of microdosed medications for presbyopia, myopia progression and mydriasis. For more Information, please visit www.eyenovia.com.

About MicroPine for Progressive Myopia

MicroPine (atropine ophthalmic solution) is being evaluated in the CHAPERONE Phase 3 clinical study for reduction in pediatric myopia progression. Progressive myopia is estimated to affect close to 5 million children in the United States who suffer from uncontrolled axial elongation of the sclera leading to increasing levels of myopia and in some cases major pathologic changes such as retinal atrophy, myopic maculopathy, retinal detachment, posterior subcapsular cataract, glaucoma and visual impairment. MicroPine has been developed for comfort, hygiene and ease-of-use in children. Microdose administration of MicroPine is anticipated to result in low systemic and ocular drug exposure. A recent therapeutic evidence assessment and review by the American Academy of Ophthalmology indicates Level 1 (highest) evidence of efficacy for the role of low dose atropine for progressive myopia (Ophthalmology 2017;124:1857-1866; Ophthalmology 2016; 123(2) 391:399).

Feasibility Dose-finding Atropine Studies: ATOM 1; ATOM 2; LAMP (Independent Collaborative Group Trials)

About MicroLine for Presbyopia

MicroLine (pilocarpine ophthalmic solution) is a pharmacologic treatment for presbyopia which will be evaluated in the VISION 1 and VISION 2 Phase 3 clinical studies. Presbyopia is the non-preventable, age-related hardening of the natural lens, which causes a gradual loss of the eye’s ability to accommodate or focus on nearby

54 Dentists Supported By 42 North Dental Receive “Top Dentist” Awards In Annual Boston Magazine Guide | News

BOSTON, Oct. 1, 2020 /PRNewswire/ — 42 North Dental, a leading dental support organization in the Northeast, announced today that 54 of their supported dentists have been awarded the honor of “Top Dentist” in Boston Magazine’s “Top Dentists in Boston” Guide, 2020. 54 is a record number of wins for any dental practice in a single year. In total, since program inception, 42 North Dental has had more “top dentist” wins than any other dental practice in the coverage area.

“I’m proud of the winning dentists and their colleagues across the company.” says Dr. Michael Scialabba, 42 North Dental Vice President of Clinical Affairs. He continues “To have other dentists in our region vote 42 North Dental dentists as ‘top dentists’ further proves our message that group dentistry, and our model, leads to exceptional patient care.”

As a member of 42 North Dental, dentists are able to focus their time and effort on maintaining positive relationships with their patients and providing expert care, rather than the business burdens that come with running a dental practice. As part of a large network of dentists, they are also able to effectively collaborate on best practices, pooling their knowledge and expertise.

And the Winners are:

Roua al Timimi – General Dentistry, Gentle Dental Quincy; Marissa Alikpala – General Dentistry, Gentle Dental Arlington; Saishree Amin – General Dentistry, Gentle Dental Wakefield, Marjan Askari – Orthodontics, Gentle Dental Arlington, Belmont, Boston, Milford, Natick, Newton, South Boston, Waltham; John Brangan – General Dentistry, Great Hill Dental Somerville; David Buczak – Endodontics, Gentle Dental South Attleboro, Saugus; Hannah Cohen – Endodontics, Gentle Dental Somerville, Wakefield, Waltham; Jose Oscar Colon – Periodontics, Gentle Dental Derry, Jamaica Plain, Nashua, Wakefield; Yonathon Dassa – General Dentistry, Gentle Dental Brookline; Leena Desai – General Dentistry, Gentle Dental Chelmsford; Ian Fessler – General Dentistry, Gillis Dental; Matteo Giamarco – General Dentistry, Gentle Dental Peabody, Robert Girschek – General Dentistry, Gentle Dental Waltham; David Goldberg – Periodontics, Abington Family Dental Care, Newbury Dental Associates, Gentle Dental Cambridge, Natick, Waltham, Worcester; Lawrence Goodman – General Dentistry, Great Hill Dental Braintree; Erin Hersey – General Dentistry, Dynamic Dental; Matthew Hickin – Periodontics, Gentle Dental Brookline, Malden, Methuen, South Boston, Great Hill Dental Peabody, Somerville; Natalia Hoffmann – Orthodontics, Gentle Dental Brighton, Jamaica Plain, Malden, Peabody, Wakefield, West Roxbury; Yong Hur – Periodontics, Great Hill Dental Boston; Maryanne Irwin – Endodontics, Great Hill Dental Boston, Braintree, ; Jennifer Kim – Endodontics, Gentle Dental Braintree, Brighton, Milford, New Bedford, Quincy, Worcester; Kirill Klimashov – Oral Surgery, Gentle Dental Arlington, Cambridge, Natick, Norwood, Somerville, Waltham, West Roxbury, Worcester; Ibrahim Lakkis – Oral Surgery, Attleboro, Braintree, Brookline, Jamaica Plain, Quincy; Ryan Lee – General Dentistry, Great Hill Dental Boston; Cheri Li – General Dentistry, Gentle Dental Cambridge;

54 Dentists Supported By 42 North Dental Receive “Top Dentist” Awards In Annual Boston Magazine Guide

“I’m proud of the winning dentists and their colleagues across the company.” says Dr. Michael Scialabba, 42 North Dental Vice President of Clinical Affairs. He continues “To have other dentists in our region vote 42 North Dental dentists as ‘top dentists’ further proves our message that group dentistry, and our model, leads to exceptional patient care.”

As a member of 42 North Dental, dentists are able to focus their time and effort on maintaining positive relationships with their patients and providing expert care, rather than the business burdens that come with running a dental practice. As part of a large network of dentists, they are also able to effectively collaborate on best practices, pooling their knowledge and expertise.

And the Winners are:

Roua al Timimi – General Dentistry, Gentle Dental Quincy; Marissa Alikpala – General Dentistry, Gentle Dental Arlington; Saishree Amin – General Dentistry, Gentle Dental Wakefield, Marjan Askari – Orthodontics, Gentle Dental Arlington, Belmont, Boston, Milford, Natick, Newton, South Boston, Waltham; John Brangan – General Dentistry, Great Hill Dental Somerville; David Buczak – Endodontics, Gentle Dental South Attleboro, Saugus; Hannah Cohen – Endodontics, Gentle Dental Somerville, Wakefield, Waltham; Jose Oscar Colon – Periodontics, Gentle Dental Derry, Jamaica Plain, Nashua, Wakefield; Yonathon Dassa – General Dentistry, Gentle Dental Brookline; Leena Desai – General Dentistry, Gentle Dental Chelmsford; Ian Fessler – General Dentistry, Gillis Dental; Matteo Giamarco – General Dentistry, Gentle Dental Peabody, Robert Girschek – General Dentistry, Gentle Dental Waltham; David Goldberg – Periodontics, Abington Family Dental Care, Newbury Dental Associates, Gentle Dental Cambridge, Natick, Waltham, Worcester; Lawrence Goodman – General Dentistry, Great Hill Dental Braintree; Erin Hersey – General Dentistry, Dynamic Dental; Matthew Hickin – Periodontics, Gentle Dental Brookline, Malden, Methuen, South Boston, Great Hill Dental Peabody, Somerville; Natalia Hoffmann – Orthodontics, Gentle Dental Brighton, Jamaica Plain, Malden, Peabody, Wakefield, West Roxbury; Yong Hur – Periodontics, Great Hill Dental Boston; Maryanne Irwin – Endodontics, Great Hill Dental Boston, Braintree, ; Jennifer Kim – Endodontics, Gentle Dental Braintree, Brighton, Milford, New Bedford, Quincy, Worcester; Kirill Klimashov – Oral Surgery, Gentle Dental Arlington, Cambridge, Natick, Norwood, Somerville, Waltham, West Roxbury, Worcester; Ibrahim Lakkis – Oral Surgery, Attleboro, Braintree, Brookline, Jamaica Plain, Quincy; Ryan Lee – General Dentistry, Great Hill Dental Boston; Cheri Li – General Dentistry, Gentle Dental Cambridge; Andrew Mancini – General Dentistry, Gentle Dental Jamaica Plain; Jonathan Millen – General Dentistry, Newbury Dental Associates; Catherine Moshirfar – Periodontics, Great Hill Dental Boston; Cassandra Myer – General Dentistry, Gentle Dental Brighton; Jake Park – Periodontics, Gentle Dental Braintree, Burlington, Chelmsford; Shimul Patel – General Dentistry, Gentle Dental Natick; David Pawlowski, Great Hill Dental Boston; Stephanie Payne– General Dentistry, Gentle Dental Malden; Joseph Purman – General Dentistry, Great Hill Dental Boston; Marisa Reason – Orthodontics, Dynamic