April 2023
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00 issues in this vol.

ASTELLAS ACQUIRES IVERIC BIO FOR ~$5.9 B

GEOGRAPHIC ATROPHY (GA)

Astellas US Holding, Inc., has agreed to acquire 100% of the outstandingshares of Iveric Bio for $40.00 per share in cash, making Iveric Bio anindirectly wholly-owned subsidiary of Astellas. This acquisition will beinclusive of Iveric's Avacincaptad Pegol (GA), for which the FDA accepteda New Drug Application with Priority Review in February anddemonstrated a 59% risk reduction in vision loss at ARVO 2023.

In its Press Release, Astellas stated it expects the acquisition to contribute to Astellas' FY2025 revenue goals and help to offset sales declines of other assets secondary to upcoming patent expiration.

EARLY DETECTION OF DIABETIC RETINOPATHY IN UNDERSERVED COMMUNITIES

DIABETIC RETINOPATHY (DR)

DR is the most common cause of vision loss in workingage adults in most developed countries. Early detectionof this condition can lead to better control of systemicA1C. Historically, the pathological changes that occur indiabetic patients precede clinically detectable changes.The theme of this year's ARVO was diversity. Dr.Edmund Arthur from the University of Alabama'sBirmingham School of Optometry presented researchthat examines the use advanced retinal imaging,optical coherence tomography angiography, to developa novel retinal vascular biomarker for early detection ofDR and diabetic macular edema (DME), especially inunderserved communities

This research was sponsored by Genentech, who continues to have the greatest breadth of marketed and pipeline products in this space.

THE SUMMIT OF AMERICAS ON IMMUNOTHERAPIES FOR HEME MALIGNANCIES

RETINITIS PIGMENTOSA

Nanoscope Therapeutics reported positive results fromits Phase 2b RESTORE trial evaluating MCO-010, agene therapy for the treatment of retinitis pigmentosa.The trial enrolled 46 patients with inherited retinaldiseases, who received a single injection of the therapy.At six months after treatment, there was a statisticallysignificant improvement in visual acuity compared toplacebo, and no serious adverse events were reported.The company's CEO stated Nanoscope has upcomingdiscussions with the FDA regarding an expeditiouspath to market forMCO-010.

These results suggest that MCO-010 has the potential to be a safe and effective treatment for patients with retinitis pigmentosa.

OPREGEN® PHASE 1/2A RESULTS DEMONSTRATE POTENTIAL TO REVERSE DISEASE PROGRESSION IN GA

GEOGRAPHIC ATROPHY

The Phase 1/2a clinical study of RG6501 is acollaboration between Genentech and Lineage CellTherapeutics. OPREGEN is an allogeneic retinal pigmentepithelial (RPE) cell therapy being developed for thetreatment of GA secondary to AMD. The study showedpreliminary evidence of outer retinal structure andvisual function improvements with OpRegen in patientswith GA and impaired vision. The study also highlightedthe potential for a single dose of OpRegen to providesignificant clinical outcomes for patients in a diseasewith a tremendous unmet need

In a space where there is only one approved option and no treatments that reverse disease progression, this novel cell therapy has the potential to be a practice-altering therapy for GA.

GENENTECH'S VABYSMO EXTENDS DOSING INTERVALS EARLY IN THE REAL-WORLD

AGE-RELATED MACULAR DEGENERATION (AMD) AND DME

LOOKING AHEAD...Among the 30 abstracts presented by Genentech at thisyear's ARVO, two Vabysmo real-world studies in wetAMD and DME demonstrated that patients extendedtheir dosing intervals early in treatment whilemaintaining or improving their vision. The majority ofpatients were able to extend their treatment intervals byat least 6 weeks during the four initial doses. Over 70%of DME patients were experiencing an extension withinthe first 2 injections. Most of these patients were comingin with 20/40 or better vision.

Vabysmo is the first bispecific antibody approved for macular diseases that has the potential for extending treatment intervals for a large population of patients.

RESEARCHERS AT UNIVERSITY COLLEGE LONDON DEVELOP AI BREAKTHROUGH IN DETECTING LEADING CAUSE OF CHILDHOOD BLINDNESS

RETINOPATHY OF PREMATURE (ROP)

A team of international researchers at University College London-Moorfields developed a deep learning Al model to screen for ROP. The Al model was trained on a sample of 7,414 images of the eyes of 1,370 newborns who had been admitted to the Homerton Hospital, London, and assessed for ROP by ophthalmologists. The algorithm was able to identify ROP with 91% accuracy, and successfully identified ROP in over 1,200 cases.

This new technology could improve early detection and treatment for ROP, potentially saving the vision of countless premature infants

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