Category Archives: Company news

PTAB Upholds Alcon Patent For Glaucoma Treatment

As reported by Law360 at URL: https://www.law360.com/ip/articles/1085124/ptab-upholds-alcon-patent-for-glaucoma-treatment

The Final Written Decision itself is included below, and can be downloaded by clicking this link:

Argentum-v-Alcon-FWD-IPR2017-01053

The patent may be viewed at the USPTO website at
http://pdfpiw.uspto.gov/.piw?Docid=08268299.

PTAB Upholds Alcon Patent For Glaucoma Treatment

Law360 (September 21, 2018, 8:52 PM EDT) — The Patent Trial and Appeal Board on Thursday upheld the validity of an Alcon patent covering the glaucoma treatment Travatan Z, rejecting arguments by generics maker Argentum that the invention was obvious.

The board held that Argentum Pharmaceuticals LLC failed to establish that a combination of publications and patents that preceded Alcon Research Ltd.’s patent would have made the challenged patent claims obvious for an ordinarily skilled artisan, according to the final written decision. Continue reading

Ivantis Fires Back: It Petitions for Invalidation of the Glaukos iStent® Patent

Last month, it was reported that Glaukos filed a lawsuit against Ivantis, alleging that the Ivantis Hydrus Microstent device infringes on patents held by Glaukos covering its iStent® devices. See “Glaukos Sues Ivantis over patents on iStent® Devices”.

Ivantis has now launched a response: In a filing on May 23, 2018, Ivantis has petitioned the USPTO to invalidate one of the two patents asserted by Glaukos in its lawsuit. Continue reading

Glaukos Sues Ivantis over patents on iStent® Devices

April 17, 2018: Glaukos Corporation of San Clemente, CA, has filed a patent infringement lawsuit against Ivantis, Inc. of Irvine, CA. The lawsuit was filed April 14, 2018.

The patents involved are:
U.S. Patent No. 6,626,858 (Lynch et al.), “Shunt Device and Method For Treating Glaucoma”
U.S. Patent No. 9,827,143 (Lynch et al.), “Shunt Device and Method For Treating Ocular Disorders”

In its Complaint, Glaukos alleges that the Ivantis Hydrus Microstent device infringes on patents held by Glaukos covering its iStent® devices.
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Aerie Pharmaceuticals Announces U.S. FDA Approval of Rhopressa® (netarsudil ophthalmic solution) 0.02% for the Lowering of Elevated Intraocular Pressure in Patients with Open-Angle Glaucoma or Ocular Hypertension

Aerie LogoAerie Pharmaceuticals, Inc. of Irvine, CA, an ophthalmic pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma and other diseases of the eye, announced on December 18, 2017, that the U.S. Food and Drug Administration (FDA) has approved Rhopressa® (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

According to the announcement, the FDA approval decision was made two months ahead of the scheduled PDUFA (Prescription Drug User Fee Act) goal date of February 28, 2018. Continue reading

Liquid Biopsy for Retinoblastoma Developed by Children’s Hospital Los Angeles and Keck Medicine of USC

A team of investigators at the Vision Center of Children’s Hospital Los Angeles and the University of Southern California (USC) Roski Eye Institute, part of Keck Medicine of USC, announced on October 12, 2017, of the publication in JAMA Ophthalmology of their study that provides proof of concept for a safe and effective way to derive genetic information from retinoblastoma tumors without removing the eye.

According to the announcement, the study indicates proof of concept for using a surrogate liquid biopsy to provide genetic profile of retinoblastoma tumors, at an earlier stage in treatment of the disease, before enucleation is indicated.

The announcement provides further explanation as follows: Continue reading

Second Sight Receives Approval to Begin Implantation and Evaluation Studies in Germany

Second Sight Medical Products, Inc., a developer, manufacturer and marketer of implantable visual prosthetics to provide useful vision to blind patients, announced on October 17, 2017, that it has received approval from Bundesinstitut für Arzneimittel und Medizinprodukte (“BfArM”), the German competent authority, and a favorable opinion by the applicable ethics committees, to begin a 10-patient study in Germany to implant and evaluate the Argus® II Retinal Prosthesis System (“Argus II”) in better sighted retinitis pigmentosa (“RP”) patients, or those individuals who have some “tunnel vision.” Tunnel vision is a condition defined by a visual field that is severely constricted.

According to the announcement:

The clinical study will be conducted with lead principal investigators at three sites in Germany as follows: Universitätsklinikum Aachen with Professor Walter, Städtisches Klinikum Kalrsruhe with Professor Augustin, and Universitätsklinikum Schleswig-Holstein, Universitätsklinikum Lübeck with Professsor Grisanti. Continue reading

Aerie Pharmaceuticals Announces FDA Advisory Committee Vote in Favor of Rhopressa™ (netarsudil ophthalmic solution) 0.02%

Aerie LogoAerie Pharmaceuticals, Inc. of Irvine, CA, a clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye, announced on October 13, 2017, of a favorable vote from members of Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA).

Before the announcement, NASDAQ had halted trading of Aerire’s common stock.

According to the announcement on the Advisory Committee’s vote, in their review of Aerie product candidate Rhopressa™ (netarsudil ophthalmic solution) 0.02%, the members of Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted as follows on the two points for Advisory Committee consideration:

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Second Sight Receives Conditional FDA Approval to Begin First Orion Human Clinical Study

Second Sight Medical Products, Inc., a developer, manufacturer and marketer of implantable visual prosthetics to provide useful vision to blind patients, announced on August 28, 2017, that the Company has received conditional approval from the U.S. Food and Drug Administration (FDA) to begin the Orion™ Cortical Visual Prosthesis System (Orion) feasibility clinical study. The conditional approval allows two U.S. sites to enroll up to five total patients. The FDA has also requested that the Company conduct additional device testing and address outstanding questions. Second Sight has 45 days to respond to FDA’s requests.
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Santen and TRACON Announce Initiation of a Phase 2a Study of DE-122 for the Treatment of Wet Age-Related Macular Degeneration

Together with Santen Pharmaceutical Co. Ltd. of Osaka, Japan, TRACON Pharmaceuticals, Inc. of San Diego, CA, announced on July 25, 2017 that Santen has initiated a Phase 2a clinical study of DE-122 in patients with wet age-related macular degeneration (AMD).

According to the announcement: The Phase 2a study is a randomized controlled trial assessing the efficacy and safety of intravitreal injections of DE-122 in combination with Lucentis® (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD. DE-122 is the ophthalmic formulation of TRACON’s proprietary anti-endoglin antibody, TRC105. The initiation of the Phase 2a study triggers a US$7 million milestone payment from Santen to TRACON.

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Allegro Ophthalmics Secures $10.7 Million in Private Financing

Allegro Ophthalmics, LLC, of San Juan Capistrano, CA, announced on June 24, 2017 that it had completed a private round of equity financing for $10.7 million.

According to the announcement: With this infusion of capital, the company is strongly positioned to reach future corporate milestones. Allegro is a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases. The company’s lead drug candidate, Luminate®, has successfully met the endpoints for two Phase 2 monotherapy studies for the treatment of diabetic macular edema (DME) and vitreomacular traction (VMT). In addition, topline results of its Phase 2, Stage 2 DME clinical trial in which Luminate is being evaluated in combination and as an adjunctive therapy with anti-VEGFs will soon be announced.
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