Spherix Ophthalmology

Spherix Global Insights is a leading provider of market research, business intelligence & advisory services to the global ophthalmology & life sciences industry

[Spherix Ophthalmology @SpherixOphtha]

The FDA has issued a CRL in response to @OutlookTx ’s BLA for ONS-5010, an ophthalmic bevacizumab to treat nAMD. Despite meeting safety/efficacy endpoints, the FDA did not approve the BLA due to CMC issues, manufacturing inspections, and a lack of substantial evidence.

[Spherix Ophthalmology @SpherixOphtha]

@Regeneron announced the FDA approval of EYLEA HD for the treatment of wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. It is the only treatment approved in wAMD and DME at 8-week and up to 16-week intervals following three monthly doses.

[Regeneron @Regeneron]

#BREAKING: The U.S. FDA has approved our treatment for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Learn more about the #FDAapproval and our ongoing commitment to those impacted by these #RetinalDiseases: https://t.co/IyNDXM50nk

[Regeneron @Regeneron]

Today, we shared positive two-year data from the pivotal clinical trial evaluating our treatment for people living with wet age-related macular degeneration. Learn more: https://t.co/l6uUJW4FPw #RetinalDiseases

[BioSpace @biospace]

@IvericBio scored a regulatory win for its geographic atrophy eye injection #Izervay, just three months after the biotech was bought by @AstellasUS Pharma for $5.9 billion.
#IvericBio #Izervay #AstellasPharma #DrugDevelopment #BioSpace
https://t.co/rYBnpBeG2L

[Spherix Ophthalmology @SpherixOphtha]

Chrystal Ferguson, Spherix's Ophthalmology Senior Insights Director, will be attending ASRS – American Society of Retina Specialists 2023 Annual Meeting in Seattle, Washington!

The ASRS conference will take place from July 28th to August 1st.

[Spherix Ophthalmology @SpherixOphtha]

Today, Spherix's Ophthalmology Senior Insights Director, Chrystal Ferguson, will be attending the OIS Retina Innovation Summit in Seattle, Washington!

Chrystal is eagerly looking forward to gaining valuable insights into the current medical needs in the retina space.

#OIS

[Spherix Ophthalmology @SpherixOphtha]

Today, @KodiakSciences announced the discontinuation of their phase 3 antibody biopolymer conjugate, tarcocimab tedromer due to a failure to meet the primary efficacy endpoints in DME alongside an unexpected increase in cataracts.

#ophthalmology #tarcocimab

[Spherix Ophthalmology @SpherixOphtha]

@AstellasUS has announced the successful completion of their acquisition of @IvericBio, which is now a wholly owned subsidiary of Astellas.

Read more: https://t.co/zLUnsPawuf

[Spherix Ophthalmology @SpherixOphtha]

Yesterday, 4D Molecular Therapeutics, Inc. announced a license agreement with @AstellasUS, granting Astellas rights to deliver their unique genetic payloads with the use of 4DMT proprietary R100 vector technology for the treatment of rare ophthalmic diseases.

#Ophthalmology

[Formycon @formycon]

Formycon has submitted the biologics license application for its aflibercept #biosimilar candidate #FYB203 to the #FDA

Please find our press release here:
https://t.co/jGQV68f3RB

#TeamFormycon #Ophthalmology #nAMD #biotech #Eylea

[Spherix Ophthalmology @SpherixOphtha]

Yesterday, @Regeneron announced it received a CRL from the @US_FDA for its BLA of 8mg aflibercept in wAMD, DME, and DR due to an ongoing review of inspection findings at a third-party filler setting back the highly anticipated launch of the Eylea follow-on agent.

[Clearside Biomedical, Inc. @clearsidebio]

Our focus may be #backoftheeye, but we think protecting the rest of the eye is pretty important too!
#clearsidebio #nationalsunglassesday #WearYourShades!

[Spherix Ophthalmology @SpherixOphtha]

Spherix Global Insights would like to recognize Diabetes Week this week!

Join us in raising awareness and advocating for advancements in treatment options. By coming together, we can empower those affected by diabetes and strive for a brighter and healthier future.

[Spherix Ophthalmology @SpherixOphtha]

Ocular Therapeutix @OCUTX announced 12-month data from its Ph1 US trial evaluating OTX-TKI, their axitinib intravitreal hydrogel implant, for the treatment of nAMD. It maintained vision comparable to aflibercept q8w, with 89% reduction in treatment burden over a 12-month period

[Ophthalmology Times @OphthTimes]

WHO and other public health companies celebrate World No Tobacco Day today.

Smokers can develop AMD up to 5.5 years earlier and are 4 times more likely to develop AMD and are 2 to 3 times more likely to develop cataracts than non-smokers.

Read More: https://t.co/xNRUEIylkv

[Spherix Ophthalmology @SpherixOphtha]

@annexonbio announced topline results from the Phase 2 clinical trial called ARCHER, evaluating the efficacy of ANX007 in individuals suffering from GA. The results reveal a significant & dosage-dependent preservation of visual function.

Read more: https://t.co/Xguy0ni2jV

[Spherix Ophthalmology @SpherixOphtha]

With summer right around the corner, be sure to take the proper precautions!

The sun is powerful and diseases like pterygium (growths on the eye), photokeratitis, and eye cancers can develop over time.

Follow these helpful tips to stay safe for Summer 2023!

[Spherix Ophthalmology @SpherixOphtha]

Oculis Holding AG announced positive top line results from the Phase 3, Stage 1 DIAMOND trial of OCS-01 eye drops in DME, & met the primary efficacy endpoint of demonstrating a statistically significant improvement in the mean BCVA ETDRS score.

Read more: https://t.co/dk52tNqqtc

[Retinal Physician @RetinalPhys]

In our special edition on #geographicatrophy, Drs. Carrera and Heier review the concept of complement inhibition. Read it in the digital edition: https://t.co/kjf4bWy2tG