Wills Eye Hospital

EyePoint Pharmaceuticals Reports First Quarter 2024 Financial Results and Highlights Recent Corporate Developments

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Mercoledì, Maggio 8, 2024
Science, FDA, AMD, Investment, DOI, Safety, OIS, Stuart, Florida, Food, Research, Cleveland Clinic, Growth, FACS, KOL, Therapy, Thomas Jefferson University, Eye, Wills Eye Hospital, Marketing, DME, Clinical trial, Associate, Diabetic retinopathy, ARVO, Plasma, Uveitis, Pharmaceutical industry

WATERTOWN, Mass., May 08, 2024 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious retinal diseases, today announced financial results for the first quarter ended March 31, 2024, and highlighted recent corporate developments.

Key Points: 
  • The Company plans to provide an update on the path forward for DURAVYU as a potential treatment in NPDR following a review of the full 12-month data in the third quarter of 2024.
  • EyePoint plans to host an R&D Day on June 26, 2024 in New York City.
  • Net product revenue for the first quarter was $0.7 million, compared to net product revenues for the first quarter ended March 31, 2023 of $7.4 million.
  • Operating expenses for the first quarter ended March 31, 2024 totaled $45.0 million versus $29.2 million in the prior year period.

Sight Sciences Announces the Results of the Three-Year Prospective GEMINI Trial and the Cross-Over Phase of the SAHARA RCT at the 2024 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting

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Martedì, Aprile 2, 2024
IOP, Gland, Signs, Ciclosporin, Glaucoma, LHT, Wills Eye Hospital, ASCRS, BCEC, Patient, Telecanthus, Meibomian gland dysfunction, Doctor of Philosophy, MD, GEMINI, DED, OMNI, Signs and symptoms, Safety, Poster, Pharmaceutical industry

MENLO PARK, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused on developing and commercializing innovative, interventional technologies intended to transform care and improve patients’ lives, announced today that data from studies of two of its proprietary glaucoma and dry eye technologies, the OMNI Surgical System (“OMNI”) and the TearCare System (“TearCare”), will be presented in two oral presentations and two posters at this year’s ASCRS Annual meeting April 5th to 8th in Boston, MA.

Key Points: 
  • OMNI technology facilitates surgeons’ ability to perform a comprehensive, implant-free, minimally invasive glaucoma surgical procedure in adults with primary open-angle glaucoma (“POAG”).
  • Lead author: Julio Echegoyen, MD, PhD
    Localized Heat Therapy (LHT) Compared to Cyclosporine Ophthalmic Emulsion (CsA): A Subanalysis on Age, Gender, and Disease Burden (SAHARA subanalysis) – poster presentation.
  • The event will be on Saturday, April 6, 2024, from 3:45 PM to 4:30 PM ET.
  • Learn more about this and other Sight Sciences activities at ASCRS at www.sightsciences.com/ascrs

Stuart Therapeutics Announces Chief Medical and Chief Financial Officer Appointments

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Giovedì, Febbraio 1, 2024
Principal, Public key certificate, Cordis, MD, Society, FDA, Columbia University, International Society, Book, Family, American Academy, Cataract, Don, Lehigh University, Culture, University, Refraction, ASCRS, Refractive surgery, Growth, American College, Mount Sinai Medical Center, Publication, Wills Eye Hospital, CFO, Congress, Therapy, Eye surgery, MBA, Executive, Accounting

STUART, Fla., Feb. 1, 2024 /PRNewswire/ -- Stuart Therapeutics, Inc. ("Stuart"), a clinical-stage biopharmaceutical company with candidate therapeutics in various phases of clinical development, today announced that it has appointed Jodi Luchs, MD to the position of Chief Medical Officer, and Don Stires to the position of Chief Financial Officer.

Key Points: 
  • STUART, Fla., Feb. 1, 2024 /PRNewswire/ -- Stuart Therapeutics, Inc. ("Stuart"), a clinical-stage biopharmaceutical company with candidate therapeutics in various phases of clinical development, today announced that it has appointed Jodi Luchs, MD to the position of Chief Medical Officer, and Don Stires to the position of Chief Financial Officer.
  • With the appointment of Dr. Luchs, Robert Baratta, MD has stepped aside from his current role as Chief Medical Officer but will continue as Stuart's Executive Chairman of the Board.
  • "Stuart Therapeutics' growth, international operations and increase in pipeline opportunities require an expansion of our team and capabilities," said Eric Schlumpf, President and Chief Executive Officer of Stuart.
  • He completed an internship at the Mount Sinai Medical Center, and his Ophthalmology residency at Long Island Jewish Medical Center.

SpliceBio Appoints Leading Ophthalmology Expert Aniz Girach as Chief Medical Officer

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Mercoledì, Gennaio 3, 2024
Conference, Wills Eye Hospital, Biotechnology, Paratriathlon, Medicine, Nightstar, Acquisition, Eli Lilly, Alcon, Retina, ProQR, Drug, MD, Ocriplasmin, Merck & Co., Stargardt disease, Abstract, Protein splicing, Laboratory, Stargardt, Merck, Gene, Genetic, Growth, Biogen, Pharmaceutical industry

BARCELONA, Spain, Jan. 3, 2024 /PRNewswire/ -- SpliceBio, a genetic medicines company harnessing Protein Splicing to develop the next generation of gene therapies, is pleased to announce the appointment of Aniz Girach, MD as Chief Medical Officer.

Key Points: 
  • BARCELONA, Spain, Jan. 3, 2024 /PRNewswire/ -- SpliceBio, a genetic medicines company harnessing Protein Splicing to develop the next generation of gene therapies, is pleased to announce the appointment of Aniz Girach, MD as Chief Medical Officer.
  • Dr Girach was Global Head of Ophthalmology at Merck & Co and Vice President, Clinical Development at Alcon Laboratories.
  • Prior to joining SpliceBio, he led the development of genetic therapies for inherited retinal diseases at ProQR Therapeutics NV as its Chief Medical Officer.
  • Aniz Girach, MD., Chief Medical Officer of SpliceBio, commented: "Inherited retinal diseases are a heterogenous group of rare diseases that can lead to severe visual disability and blindness, affecting approximately 5.5 million people worldwide.

SpliceBio Appoints Leading Ophthalmology Expert Aniz Girach as Chief Medical Officer

Retrieved on: 
Mercoledì, Gennaio 3, 2024
Conference, Wills Eye Hospital, Biotechnology, Paratriathlon, Medicine, Nightstar, Acquisition, Eli Lilly, Alcon, Retina, ProQR, Drug, MD, Ocriplasmin, Merck & Co., Stargardt disease, Abstract, Protein splicing, Laboratory, Stargardt, Merck, Gene, Genetic, Growth, Biogen, Pharmaceutical industry

BARCELONA, Spain, Jan. 3, 2024 /PRNewswire/ -- SpliceBio, a genetic medicines company harnessing Protein Splicing to develop the next generation of gene therapies, is pleased to announce the appointment of Aniz Girach, MD as Chief Medical Officer.

Key Points: 
  • BARCELONA, Spain, Jan. 3, 2024 /PRNewswire/ -- SpliceBio, a genetic medicines company harnessing Protein Splicing to develop the next generation of gene therapies, is pleased to announce the appointment of Aniz Girach, MD as Chief Medical Officer.
  • Dr Girach was Global Head of Ophthalmology at Merck & Co and Vice President, Clinical Development at Alcon Laboratories.
  • Prior to joining SpliceBio, he led the development of genetic therapies for inherited retinal diseases at ProQR Therapeutics NV as its Chief Medical Officer.
  • Aniz Girach, MD., Chief Medical Officer of SpliceBio, commented: "Inherited retinal diseases are a heterogenous group of rare diseases that can lead to severe visual disability and blindness, affecting approximately 5.5 million people worldwide.

Renowned Philadelphia Oculoplastic Surgeon, Dr. John J.W. Lee, Named a 2023 Top Patient Rated Doctor by Find Local Doctors

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Mercoledì, Novembre 15, 2023
Specialization, Eyelid, Ophthalmic, Patient, Multimedia, Hospital, Society, Wills Eye Hospital, Dentistry, Nursing, Blepharoplasty

BRYN MAWR, Pa., Nov. 15, 2023 /PRNewswire-PRWeb/ -- Dr. John J.W. Lee, a highly-credentialed oculoplastic and reconstructive surgeon in the Philadelphia, PA, area has recently been recognized as a Top Patient Rated Doctor by Find Local Doctors. His patient-centered approach and expert knowledge in oculoplastic procedures have fostered a large volume of outstanding reviews from his patients across multiple online sources. Such superior ratings have led Find Local Doctors, a credible online directory of medical providers, to honor him with this award. Dr. Lee is a skilled oculoplastic surgeon who is highly sought-after for his specialization in reconstructive, revisional and cosmetic surgery of the eyes and surrounding tissue. Dr. Lee is known for exceptional Blepharoplasty (Eyelid Surgery) outcomes. He also operates a full-service med spa, Lux Skin Lasers, which offers the latest non-surgical treatments in facial rejuvenation. Renowned for his artistic approach and meticulous attention to detail, Dr. Lee holds elite qualifications and experience in his field. He has spent 15+ years performing over 12,000+ eyelids surgeries and has honed and evolved his surgical techniques. Using the latest advancements and cutting-edge technology at his clinic, Dr. Lee passionately pursues new innovative techniques to produce beautiful results with minimal downtime for his patients.

Key Points: 
  • Dr. Lee is known for his expertise in Blepharoplasty (Eyelid Surgery) and exceptional outcomes with Facial Fillers and Neuromodulators.
  • Lee, a highly-credentialed oculoplastic and reconstructive surgeon in the Philadelphia, PA, area has recently been recognized as a Top Patient Rated Doctor by Find Local Doctors .
  • Such superior ratings have led Find Local Doctors, a credible online directory of medical providers, to honor him with this award.
  • Renowned for his artistic approach and meticulous attention to detail, Dr. Lee holds elite qualifications and experience in his field.

Aura Biosciences Receives FDA Agreement Under Special Protocol Assessment (SPA) for CoMpass Phase 3 Clinical Trial of Belzupacap Sarotalocan (Bel-sar) in Early-stage Choroidal Melanoma

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Lunedì, Novembre 6, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Neoplasm, Wills Eye Hospital, Șaeș, CM, Food, I Am the Moon, AAO, Compass, Cohort, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Radiation, American Academy, American Academy of Ophthalmology, Annual general meeting, Paratriathlon, Safety, Visual acuity, SPA, Patient, SC, VDC, Thomas Jefferson University, Pharmaceutical industry, Ophthalmology

The results were presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting in San Francisco, California.

Key Points: 
  • The results were presented at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting in San Francisco, California.
  • The safety profile continues to be favorable with no treatment-related serious adverse events or significant adverse events.
  • The Phase 3 trial is designed as a superiority trial comparing bel-sar versus sham.
  • The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 19 adult patients.

Outlook Therapeutics® Provides Regulatory Update on FDA Review of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

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Mercoledì, Agosto 30, 2023
Retina, Bevacizumab, AMD, Public, CMC, Wills Eye Hospital, Outlook, MD, Patient, Agency, Webcast, CRL, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Safety, Cryptocurrency, Pharmaceutical industry

ISELIN, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the U.S. Food and Drug Administration (FDA) has issued a CRL to the Company’s BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the Agency concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.

Key Points: 
  • “We continue to believe in the public health need to provide the retina community with an FDA-approved bevacizumab treatment option for wet AMD.
  • We will request a formal meeting as soon as possible with the FDA to further understand the BLA deficiencies and how best to resolve them.
  • Following this meeting with the FDA, the Company will be able to discuss next steps and the expected timing for resolution,” said Russell Trenary, President and CEO of Outlook Therapeutics.
  • Interested participants and investors may access the conference call by dialing (877) 407-8291 (domestic) or (201) 689-8345 (international).

Sight Sciences Announces Positive Results and Primary Endpoint Successfully Met in SAHARA, a Randomized Controlled Clinical Trial Comparing Interventional Eyelid Procedures Enabled by TearCare® Technology to Restasis¹ for the Treatment of Dry Eye

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Giovedì, Luglio 20, 2023
American Academy of Optometry, RCT, Eye disease, American Academy, Wills Eye Hospital, Gland, OSDI, Telecanthus, Optometry, Patient, Physician, Randomized controlled trial, Entrepreneurship, Principal, Bias, MGD, Pharmaceutical industry, Medical imaging, MD, Ciclosporin

The trial successfully met its primary endpoint and the data reported statistically significant improvements as compared to Restasis eye drops for the treatment of dry eye disease.

Key Points: 
  • The trial successfully met its primary endpoint and the data reported statistically significant improvements as compared to Restasis eye drops for the treatment of dry eye disease.
  • The SAHARA trial also observed that procedures enabled by TearCare were non-inferior to Restasis eyedrops in Ocular Surface Disease Index (OSDI), which was the co-primary six-month endpoint.
  • Symptoms endpoints include two commonly used patient-reported questionnaires: Ocular Surface Disease Index (OSDI) and Symptom Assessment in Dry Eye (SANDE).
  • Sight Sciences designed its TearCare technology and its comprehensive interventional eyelid procedure to safely and effectively treat the underlying obstructive causes of MGD.

OcuTerra Completes Enrollment in Phase 2 DR:EAM Clinical Trial of Topically Delivered OTT166 in Adults with Diabetic Retinopathy

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Martedì, Luglio 18, 2023
Health, Diabetes, General Health, Clinical Trials, Pharmaceutical, Optical, Biotechnology, Retina, Thomas Jefferson University, Clinical trial, DR, DRSS, Diabetic retinopathy, Wills Eye Hospital, RGD, ClinicalTrials.gov, Synthetic control method, Patient, Engineering, PDR, Principal, Paratriathlon, Therapy, Safety, Disease, Pharmaceutical industry, Medical device, Ophthalmology

“With limited therapeutic options for the treatment of DR on the market, we recognize an immense need for a non-invasive, earlier intervention.

Key Points: 
  • “With limited therapeutic options for the treatment of DR on the market, we recognize an immense need for a non-invasive, earlier intervention.
  • The trial enrolled 225 adult patients who were randomly assigned one of two doses of OTT166 or to one of two control groups receiving vehicle.
  • OTT166 is a small molecule RGD integrin inhibitor delivered topically in the form of an eye drop and is purpose-engineered to distribute to the retina in therapeutic concentrations.
  • “This is an essential milestone for the development of a treatment that could benefit millions of patients with DR.”